IP Library › Granted Patent US 12,447,139
Granted Patent B2
US 12,447,139 · App. 19/021,696 · Granted Oct 21, 2025

Levodopa dosing regimen

Inventors: Richard D'Souza (Morristown, NJ); Hester Visser (Neshanic Station, NJ); Suneel Gupta (Hayward, CA)
Assignee: Amneal Pharmaceuticals, LLC
A61K31/198A61K9/5005A61P25/16
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Quick Facts
Patent No.
US 12,447,139
App. No.
19/021,696
Granted
Oct 21, 2025
Kind
B2
Abstract

The invention is a method for treating patients with Parkinson's disease by orally administering a controlled release levodopa formulation and the method provides an improvement of a patient's total post-dose “Off” time, total post dose “On” time and total post dose “Good On” time compared to post-dose of treatment regimens with oral immediate release levodopa tablets.

Claims (55)

1. A method for treating a patient diagnosed with Parkinson's disease comprising:

(i) selecting a patient diagnosed with Parkinson's disease and being treated with oral immediate release levodopa tablets for a total daily levodopa dose of less than 500 mg;

(ii) determining the amount of levodopa administered to the patient with each administration of the immediate release levodopa tablets of step (i);

(iii) determining the patient's most frequent dose of immediate release levodopa tablets from step (ii);

(iv) discontinuing the administration of the immediate release levodopa tablets; and

(v) orally administering one or more multiparticulate controlled release levodopa dosage forms twice or thrice a day to the patient, wherein the amount of levodopa administered with each administration of the multiparticulate controlled release levodopa dosage form is 2.8 times the amount of levodopa the patient was receiving with each administration of the most frequent dose of immediate release levodopa tablets of step (iii),

wherein the patient after receiving treatment with the multiparticulate controlled release levodopa dosage form exhibits a decrease of at least 5% of the patient's total post dose “Off” time as compared to post dose of the oral immediate release levodopa tablets; and

wherein the multiparticulate controlled release dosage form is free of a catechol-O-methyl transferase inhibitor and comprises:

(a) a controlled release component comprising a plurality of beads that pass through a 12 mesh screen but are retained on a 24 mesh screen wherein the beads are substantially free of carbidopa and comprise: (i) a core comprising levodopa, (ii) a controlled release coating surrounding the core, (iii) a coating comprising a muco-adhesive polymer surrounding the controlled release coating, and (iv) a coating comprising an enteric polymer that surrounds the coating comprising the muco-adhesive polymer; and

(b) an immediate release component comprising levodopa and carbidopa.

2. The method of claim 1 , wherein the Parkinson's disease is primary parkinsonism, post-encephalitic parkinsonism, parkinsonism following carbon monoxide intoxication, or parkinsonism following manganese intoxication.

3. The method of claim 1 , wherein the multiparticulate controlled release dosage form is a capsule comprising:

140 mg of levodopa and 35 mg of carbidopa;

210 mg of levodopa and 52.5 mg of carbidopa;

280 mg of levodopa and 70 mg of carbidopa; or

350 mg of levodopa and 87.5 mg of carbidopa;

and the dose of levodopa administered in step (v) is provided by administering one or a combination of the foregoing capsules per dosing time.

4. The method of claim 3 , wherein the immediate release component comprises from about 90% to about 100% of the total amount of carbidopa in the multiparticulate controlled release formulation.

5. The method of claim 4 , wherein the multiparticulate controlled release dosage form when tested using a USP Apparatus I at 75 rpm and 37°±0.5° C. with 500-900 ml of simulated gastric fluid for 2 hours and pH 6.8 phosphate buffer thereafter exhibits the following levodopa release profile:

20% to 60% of levodopa is released after 2 hours;

40% to 80% of levodopa is released after 3 hours;

60% to 100% of levodopa is released after 4 hours; and

not less than 80% is released after 7 hours,

wherein the simulated gastric fluid has a pH of about 1 to about 4.

6. The method of claim 4 , wherein the controlled release coating comprises a controlled release material selected from the group consisting of ethyl cellulose, cellulose acetate, and mixtures thereof.

7. The method of claim 4 , wherein the mucoadhesive polymer is capable of forming a positive ionic charge at pHs present in the human gastrointestinal tract.

8. The method of claim 7 , wherein the mucoadhesive polymer is an amino methacrylate copolymer.

9. The method of claim 8 , wherein the amino methacrylate copolymer is poly(butyl methacrylate-co-(2-dimethylaminoethyl) methacrylate-co-methylmethacrylate).

10. The method of claim 4 , wherein step (v) comprises administering one or more of the multiparticulate controlled release levodopa dosage forms to the patient twice a day.

11. The method of claim 4 , wherein step (v) comprises administering one or more of the multiparticulate controlled release levodopa dosage forms to the patient thrice a day.

12. The method of claim 4 , wherein step (v) further comprises initially administering one or more of the multiparticulate controlled release levodopa dosage forms to the patient twice a day for one to nine days and thereafter administering the multiparticulate controlled release levodopa dosage forms thrice a day.

13. A method for treating a patient diagnosed with Parkinson's disease comprising:

(i) selecting a patient diagnosed with Parkinson's disease and being treated with oral immediate release levodopa tablets administered four or five times a day with each dose of oral immediate release levodopa tablets comprising 100 mg of levodopa;

(ii) discontinuing the administration of the immediate release levodopa tablets to the patient of step (i); and

(iii) orally administering one or more controlled release levodopa capsules twice or thrice a day to the patient,

wherein the one or more capsules are free of a catechol-O-methyl transferase inhibitor and comprise:

(a) a controlled release component comprising a plurality of plurality of beads that pass through a 12 mesh screen but are retained on a 24 mesh screen wherein the beads are substantially free of carbidopa and comprise: (i) a core comprising levodopa, (ii) a controlled release coating surrounding the core, (iii) a coating comprising a muco-adhesive polymer surrounding the controlled release coating, and (iv) a coating comprising an enteric polymer surrounding the coating comprising the muco-adhesive polymer; and

(b) an immediate release component comprising levodopa and carbidopa, wherein each administration of the one or more capsules comprises a total of 280 mg of levodopa; and

wherein the patient after receiving treatment with the one or more capsules exhibits a decrease of at least 5% of the patient's total post dose “Off” time as compared to post dose of the oral immediate release levodopa tablets.

14. The method of claim 13 , wherein the Parkinson's disease is primary parkinsonism, postencephalitic parkinsonism, parkinsonism following carbon monoxide intoxication, or parkinsonism following manganese intoxication.

15. The method of claim 13 wherein the controlled release levodopa capsule comprises 280 mg of levodopa and 70 mg of carbidopa; and the dose of levodopa administered in step (iii) is provided by administering one capsule per dosing time.

16. The method of claim 13 , wherein the immediate release component comprises from about 90% to about 100% of the total amount of carbidopa in the controlled release levodopa capsules.

17. The method of claim 16 , wherein the controlled release levodopa capsules when tested using a USP Apparatus I at 75 rpm and 37°±0.5° C. with 500-900 ml of simulated gastric fluid for 2 hours and pH 6.8 phosphate buffer thereafter exhibits the following levodopa release profile:

20% to 60% of levodopa is released after 2 hours;

40% to 80% of levodopa is released after 3 hours;

60% to 100% of levodopa is released after 4 hours; and

not less than 80% is released after 7 hours,

wherein the simulated gastric fluid has a pH of about 1 to about 4.

18. The method of claim 16 , wherein the controlled release coating comprises a controlled release material selected from the group consisting of ethyl cellulose, cellulose acetate, and mixtures thereof.

19. The method of claim 16 , wherein the mucoadhesive polymer is capable of forming a positive ionic charge at pHs present in the human gastrointestinal tract.

20. The method of claim 19 , wherein the mucoadhesive polymer is an amino methacrylate copolymer.

21. The method of claim 20 , wherein the amino methacrylate copolymer is a poly(butyl methacrylate-co-(2-dimethylaminoethyl) methacrylate-co-methylmethacrylate).

22. The method of claim 16 , wherein step (iii) comprises administering one or more of the controlled release levodopa capsules to the patient twice a day.

23. The method of claim 16 , wherein step (iii) comprises administering one or more of the controlled release levodopa capsules to the patient thrice a day.

24. The method of claim 16 , wherein step (iii) further comprises initially administering one or more of the controlled release levodopa capsules to the patient twice a day for one to nine days and thereafter administering the controlled release levodopa capsules thrice a day.

Assignments (3)
SECURITY INTEREST Recorded Sep 22, 2025
From: AMNEAL PHARMACEUTICALS LLC; IMPAX LABORATORIES, LLC
To: TRUIST BANK, AS COLLATERAL AGENT
Reel/Frame 072321/0852 →
SECURITY INTEREST Recorded Aug 1, 2025
From: AMNEAL PHARMACEUTICALS LLC; IMPAX LABORATORIES, LLC
To: JPMORGAN CHASE BANK, N.A., AS COLLATERAL AGENT
Reel/Frame 071905/0166 →
PATENT SECURITY AGREEMENT Recorded Aug 1, 2025
From: AMNEAL PHARMACEUTICALS LLC; IMPAX LABORATORIES, LLC; GEMINI LABORATORIES, LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS COLLATERAL AGENT
Reel/Frame 072312/0127 →
Continuity (9)
Continuation 18823575 · Sep 3, 2024
Continuation 18634040 · Apr 12, 2024
Continuation 17967332 · Oct 17, 2022
Continuation In Part 17558337 · Dec 21, 2021
Provisional Application 63247639 · Sep 23, 2021
Provisional Application 63236403 · Aug 24, 2021
Provisional Application 63150121 · Feb 17, 2021
Provisional Application 63129063 · Dec 22, 2020
Related Publication 20250152539A1 · May 15, 2025
References Cited (293)
US 3891696A · Bodor et al. · 1975 [cited by applicant]
US 4021555A · Seyfried et al. · 1977 [cited by applicant]
US 4160020A · Ayer et al. · 1979 [cited by applicant]
US 4367217A · Gruber et al. · 1983 [cited by applicant]
US 4424235A · Sheth et al. · 1984 [cited by applicant]
US 4427648A · Brickl et al. · 1984 [cited by applicant]
US 4438091A · Grubet et al. · 1984 [cited by applicant]
US 4826875A · Chiesi · 1989 [cited by applicant]
US 4839177A · Colombo et al. · 1989 [cited by applicant]
US 4849227A · Cho · 1989 [cited by applicant]
US 4855326A · Fuisz · 1989 [cited by applicant]
US 4900755A · Dempski et al. · 1990 [cited by applicant]
US 4938968A · Mehta · 1990 [cited by applicant]
US 5051262A · Panoz et al. · 1991 [cited by applicant]
US 5135950A · Pippuri et al. · 1992 [cited by applicant]
US 5188840A · Tida et al. · 1993 [cited by applicant]
US 5446194A · Bäckström et al. · 1995 [cited by applicant]
US 5532274A · Wenzel et al. · 1996 [cited by applicant]
US 5576022A · Yang et al. · 1996 [cited by applicant]
US 5594030A · Conte et al. · 1997 [cited by applicant]
US 5624960A · Wenzel et al. · 1997 [cited by applicant]
US 5637320A · Bourke et al. · 1997 [cited by applicant]
US 5650169A · Conte et al. · 1997 [cited by applicant]
US 5652271A · Harris et al. · 1997 [cited by applicant]
US 5681583A · Conte et al. · 1997 [cited by applicant]
US 5738874A · Conte et al. · 1998 [cited by applicant]
US 5773031A · Shah et al. · 1998 [cited by applicant]
US 5780057A · Conte et al. · 1998 [cited by applicant]
US 5840756A · Cohen et al. · 1998 [cited by applicant]
US 5945424A · Schmidt · 1999 [cited by applicant]
US 6024981A · Khankari et al. · 2000 [cited by applicant]
US 6027748A · Conte et al. · 2000 [cited by applicant]
US 6126969A · Shah et al. · 2000 [cited by applicant]
US 6183778B1 · Conte et al. · 2001 [cited by applicant]
US 6194000B1 · Smith et al. · 2001 [cited by applicant]
US 6221392B1 · Khankari et al. · 2001 [cited by applicant]
US 6238699B1 · Rubin · 2001 [cited by applicant]
US 6294200B1 · Conte et al. · 2001 [cited by applicant]
US 6309666B1 · Hatano et al. · 2001 [cited by applicant]
US 6372252B1 · Blume et al. · 2002 [cited by applicant]
US 6372254B1 · Ting et al. · 2002 [cited by applicant]
US 6376545B1 · Levin · 2002 [cited by applicant]
US 6500867B1 · Virkki et al. · 2002 [cited by applicant]
US 6531153B2 · Seth · 2003 [cited by applicant]
US 6602521B1 · Ting et al. · 2003 [cited by applicant]
US 6627223B2 · Percel et al. · 2003 [cited by applicant]
US 6630162B1 · Nilvebrant et al. · 2003 [cited by applicant]
US 6723348B2 · Faham et al. · 2004 [cited by applicant]
US 6730321B2 · Ting et al. · 2004 [cited by applicant]
US 6733781B2 · Abu-Izza et al. · 2004 [cited by applicant]
US 6793936B2 · Devane et al. · 2004 [cited by applicant]
US 6797732B2 · Virkki et al. · 2004 [cited by applicant]
US 6811794B2 · Burnside et al. · 2004 [cited by applicant]
US 7048945B2 · Percel et al. · 2006 [cited by applicant]
US 7094427B2 · Han et al. · 2006 [cited by applicant]
US 8377474B2 · Hsu et al. · 2013 [cited by applicant]
US 8591913B2 · Miyazaki et al. · 2013 [cited by applicant]
US 10098845B2 · Hsu et al. · 2018 [cited by applicant]
US 10292935B2 · Hsu et al. · 2019 [cited by applicant]
US 10688058B2 · Hsu et al. · 2020 [cited by applicant]
US 10973769B2 · Hsu et al. · 2021 [cited by applicant]
US 10987313B2 · Hsu et al. · 2021 [cited by applicant]
US 11357733B2 · Hsu et al. · 2022 [cited by applicant]
US 11622941B2 · Hsu et al. · 2023 [cited by applicant]
US 11666538B2 · Hsu et al. · 2023 [cited by applicant]
US 20020155154A1 · Wong et al. · 2002 [cited by applicant]
US 20030147957A1 · Licht et al. · 2003 [cited by applicant]
US 20030152628A1 · Licht et al. · 2003 [cited by applicant]
US 20030224045A1 · Han et al. · 2003 [cited by applicant]
US 20040028613A1 · Quay · 2004 [cited by applicant]
US 20040166159A1 · Han et al. · 2004 [cited by applicant]
US 20050070608A1 · Remenar et al. · 2005 [cited by applicant]
US 20050147670A1 · Hsu et al. · 2005 [cited by applicant]
US 20050203185A1 · Remenar et al. · 2005 [cited by applicant]
US 20060013875A1 · Han et al. · 2006 [cited by applicant]
US 20060018965A1 · Moodley et al. · 2006 [cited by applicant]
US 20060045865A1 · Jacob et al. · 2006 [cited by applicant]
US 20060057197A1 · Han et al. · 2006 [cited by applicant]
US 20070003621A1 · Nangia et al. · 2007 [cited by applicant]
US 20070082048A1 · Warner · 2007 [cited by applicant]
US 20070148238A1 · Nangia et al. · 2007 [cited by applicant]
US 20070190145A1 · Venkatesh et al. · 2007 [cited by applicant]
US 20070275060A1 · Befumo et al. · 2007 [cited by applicant]
US 20080131492A1 · Nangia et al. · 2008 [cited by applicant]
US 20080299204A1 · Nangia et al. · 2008 [cited by applicant]
US 20090004229A1 · Pastini et al. · 2009 [cited by applicant]
US 20090220611A1 · Dargelas et al. · 2009 [cited by applicant]
US 20100298268A1 · Hsu et al. · 2010 [cited by applicant]
US 20100331244A1 · Miyazaki · 2010 [cited by applicant]
US 20110111024A1 · Mao et al. · 2011 [cited by applicant]
US 20120177731A1 · Hsu et al. · 2012 [cited by applicant]
US 20130195973A1 · Gupta et al. · 2013 [cited by applicant]
US 20160250170A1 · Hsu et al. · 2016 [cited by applicant]
US 20160287523A1 · Hsu et al. · 2016 [cited by applicant]
US 20190254978A1 · Hsu et al. · 2019 [cited by applicant]
US 20200009062A1 · Hsu et al. · 2020 [cited by applicant]
US 20200253881A1 · Hsu et al. · 2020 [cited by applicant]
US 20210128480A1 · Hsu et al. · 2021 [cited by applicant]
US 20210338591A1 · Hsu et al. · 2021 [cited by applicant]
US 20230301923A1 · Hsu et al. · 2023 [cited by applicant]
EP 0253490 · 1988 [cited by applicant]
EP 0313845 · 1989 [cited by applicant]
EP 0320051 · 1989 [cited by applicant]
EP 0393572 · 1990 [cited by applicant]
EP 1262198 · 2002 [cited by applicant]
EP 1964566 · 2008 [cited by applicant]
EP 2508174 · 2012 [cited by applicant]
WO 1995001781 · 1995 [cited by applicant]
WO 1999004765 · 1999 [cited by applicant]
WO 199917745 · 1999 [cited by applicant]
WO 1999017745 · 1999 [cited by applicant]
WO 1999051209 · 1999 [cited by applicant]
WO 2000015197 · 2000 [cited by applicant]
WO 2000018447 · 2000 [cited by applicant]
WO 2002000213 · 2002 [cited by applicant]
WO 2003000018 · 2003 [cited by applicant]
WO 2003005967 · 2003 [cited by applicant]
WO 2003101432 · 2003 [cited by applicant]
WO 2004062577 · 2004 [cited by applicant]
WO 2005023185 · 2005 [cited by applicant]
WO 2005099678 · 2005 [cited by applicant]
WO 2006026556 · 2006 [cited by applicant]
WO 2007002516 · 2007 [cited by applicant]
WO 2007002518 · 2007 [cited by applicant]
WO 2007022956 · 2007 [cited by applicant]
WO 2007090091 · 2007 [cited by applicant]
WO 2009085306 · 2009 [cited by applicant]
WO 2010134074 · 2010 [cited by applicant]
WO 2010140531 · 2010 [cited by applicant]
WO 2012136819 · 2012 [cited by applicant]
WO 2015054302 · 2015 [cited by applicant]
Impax Laboratories, LLC, “A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease,” ClinicalTrials.gov archive (identifier NCT02271530), Oct. 22, 2014, 9 pages. [cited by applicant]
Impax Laboratories, LLC, “A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor Fluctuations,” ClinicalTrials.gov archive (identifier NCT03670953), Sep. 14, 2018, 7 pages. [cited by applicant]
Impax Laboratories, LLC, “Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations,” ClinicalTrials.gov archive (identifier NCT03877510), Mar. 15, 2019, 14 pag… [cited by applicant]
Impax Laboratories, LLC, “A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease,” ClinicalTrials.gov archive (identifier NCT03007888) Jan. 2, 2017, 7 pages. [cited by applicant]
Impax Laboratories, LLC, “An Open-Label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients with Motor Fluctuations,” Clinicaltrialsregister.eu, EudraCT No. 2018-002234-21 (Germa… [cited by applicant]
Impax Laboratories, LLC, “An Open-Label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients with Motor Fluctuations,” Clinicaltrialsregister.eu, EudraCT No. 2018-002234-21 (Czech… [cited by applicant]
Stacy et al., “Motor Effects and Safety of IPX203, an Investigational Extended-Release Formulation of Carbidopa-Levodopa, in Advanced Parkinson's Disease: A Single Dose Study,” Poster presented at the American Academy o… [cited by applicant]
Stacy et al., “Motor Effects and Safety of IPX203, an Investigational Extended-Release Formulation of Carbidopa-Levodopa, in Advanced Parkinson's Disease: A Single Dose Study,” Poster presented at the 21st International… [cited by applicant]
Mittur et al., “Multiple-Dose Pharmacodynamics of IPX203: A New Investigational Oral Extended-Release Formulation of Carbidopa-Levodopa, in Patients with Advanced Parkinson's Disease,” Poster presented at the Annual Mee… [cited by applicant]
Opposition submission against European Patent No. 2 234 963 filed by Dr. Luigi Rumi, Jan. 7, 2021. [cited by applicant]
Hayashi et al., “Physiological Mechanism for Enhancement of Paracellular Drug Transport,” Journal of Controlled Release 62 (1999) pp. 141-148. [cited by applicant]
Nagayama et al., “Effect of Ascorbic Acid on the Pharmacokinetics of Levodopa in Elderly Patients with Parkinson Disease,” Clin. Neuropharmacol., vol. 27, No. 6, Nov.-Dec. 2004, pp. 270-273. [cited by applicant]
Opposition submission against European Patent No. 2 234 963 filed by Teva Pharmaceutical industries, Limited, Jan. 7, 2021. [cited by applicant]
Carbidopa and Levodopa Tablet, extended release, Package Insert, Mylan Pharmaceuticals Inc., Feb. 2020 revision (original publication 1999). [cited by applicant]
LeWitt et al., “Controlled-Release Carbidopa/Levodopa (Sinemet 50/200 CR4) Clinical and Pharmacokinetic Studies,” Neurology 1989; 39 (Suppl. 2); pp. 45-53. [cited by applicant]
Response to Oppositions of European Patent No. 2 234 967 filed by Impax Laboratories LLC Jun. 8, 2021. [cited by applicant]
Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 9th ed. (1996), pp. 509-511. [cited by applicant]
Opposition submission against European Patent No. 3 054 929 filed by Dr. Luigi Rumi, May 5, 2021. [cited by applicant]
Summons and Preliminary Non-Binding Opinion of the Opposition Division in the opposition of European Patent No. 2 234 963 dated Dec. 23, 2021. [cited by applicant]
Summons and Preliminary Non-Binding Opinion of the Opposition Division in the opposition of European Patent No. 3 054 929 dated Dec. 16, 2021. [cited by applicant]
Roy et al., “Polymers in Mucoadhesive Drug-Delivery Systems: A Brief Note,” Designed Monomers and Polymers 12 (2009) pp. 483-495. [cited by applicant]
Inbrija (levodopa inhalation powder) Prescribing Information, Aug. 2020. [cited by applicant]
Impax Laboratories, LLC, “A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor Fluctuations,” ClinicalTrials.gov archive (identifier NCT03670953), Jul. 26, 2021 update, 7 page… [cited by applicant]
PCT International Search Report for PCT/US2014/059554, Jan. 13, 2015. [cited by applicant]
PCT International Written Opinion for PCT/US2014/059554, Jan. 13, 2015. [cited by applicant]
PCT International Preliminary Report on Patentability for PCT/US2014/059554, Apr. 12, 2016. [cited by applicant]
Armstrong et al., Diagnosis and Treatment of Parkinson's Disease: A Review. JAMA. Feb. 2020;323:548-560. [cited by applicant]
Bibbiani et al., “Continuous Dopaminergic Stimulation Reduces Risk of Motor Complications in Parkinsonian P,” Exp Neurol. Jan. 2005;192(1):73-8. [cited by applicant]
Cilia et al., “The Modern Pre-Levodopa Era of Parkinson's Disease: Insights Into Motor Complications From Sub-Saharan Africa,” Brain. Jul. 2014;137(10):2731-42. [cited by applicant]
Freitas et al., “Motor Complications of Dopaminergic Medications in Parkinson's Disease,” Semin Neurol. Apr. 2017;37:147-157. [cited by applicant]
Jankovic et al., “Therapies in Parkinson's Disease,” Curr Opin Neurol. Aug. 2012;25(4):433-47. [cited by applicant]
LeWitt et al., “Levodopa Therapy for Parkinson Disease a Look Backward and Forward,” Neurology. Apr. 2016;86 (Suppl 1):S3-12. [cited by applicant]
Mittur et al., “Pharmacokinetics of Rytary, an Extended-Release Capsule Formulation of Carbidopa-Levodopa,” Clin Pharmacokinet. Feb. 2017;56:999-1014. [cited by applicant]
Nilsson et al., “Duodenal Levodopa Infusion in Parkinson's Disease-Long-Term Experience,” Acta Neurologica Scandinavica. Jun. 2001;104:343-348. [cited by applicant]
Nyholm et al., “Duodenal Levodopa Infusion Monotherapy vs Oral Polypharmacy in Advanced Parkinson Disease,” Neurology. Jan. 2005;64:216-223. [cited by applicant]
Olanow et al. “Double-Blind, Double-Dummy, Randomized Study of Continuous Intrajejunal Infusion of Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease,” Lancet Neurol. Feb. 2014; 13:141-149. [cited by applicant]
Othman et al., “Levodopa-Carbidopa Intestinal Gel Pharmacokinetics: Lower Variability Than Oral Levodopa-Carbidopa,” J Parkinson's Dis. Jan. 2017;7:275-8. [cited by applicant]
Pfeiffer et al. “Clinical Implications of Gastric Complications on Levodopa Treatment in Parkinson's Disease,” Parkinsonism Relat Disord. May 2020;76:63-71. [cited by applicant]
Stocchi et al., “Intermittent vs Continuous Levodopa Administration in Patients with Advanced Parkinson Disease: a Clinical and Pharmacokinetic Study,” Arch Neurol. Jun. 2005:62(6):905-910. [cited by applicant]
Zhang et al., “The Advantages of Levodopa-Carbidopa Intestinal Gel for Patients with Advanced Parkinson's Disease: a Systematic Review,” Drug Des Devel Ther. Feb. 2020; 14:845-54. [cited by applicant]
Response to opposition of European Patent No. 3 054 929 dated Sep. 17, 2021. [cited by applicant]
Response to opposition of European Patent No. 2 234 963 dated Jun. 8, 2021. [cited by applicant]
Inbrija (levodopa inhalation powder) Prescribing Information, Dec. 2018. [cited by applicant]
Margolesky et al., “Extended-Release Oral Capsule of Carbidopa-Levodopa in Parkinson Disease,” Therapeutic Advances in Neurological Disorders 2018, vol. 11, pp. 1-12. [cited by applicant]
PCT International Search Report for PCT/US2021/064693, Mar. 17, 2022. [cited by applicant]
PCT International Written Opinion for PCT/US2021/064693, Mar. 17, 2022. [cited by applicant]
Response to Summons to Attend Oral Proceedings in opposition of European Patent No. 3 054 929 dated Jul. 29, 2022. [cited by applicant]
Declaration of Richard D'Souza submitted on Jul. 29, 2022 in response to Summons to Attend Oral Proceedings in opposition of European Patent No. 3 054 929. [cited by applicant]
Response to Summons to Attend Oral Proceedings in opposition of European Patent No. 2 234 963 dated Jul. 15, 2022. [cited by applicant]
Declaration of Anita Kumar submitted on Jul. 15, 2022 in response to Summons to Attend Oral Proceedings in opposition of European Patent No. 2 234 963. [cited by applicant]
Nyholm, Dag, “Phamacotherapy for Parkinson's Disease—Observations and Innovations,” Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine 1236, May 2003. [cited by applicant]
Lewitt, Peter et al., “New Developments in Levodopa Therapy,” Neurology, 62(1 suppl. 1):S9-S16, Jan. 2004. [cited by applicant]
Han, Chien-Hsuan, Declaration Under 37 C.F.R. §1.132, Oct. 14, 2004. [cited by applicant]
Hiroshi, et al., “The Effect of Ascorbic Acid on the Pharmacokinetics of Levodopa in Elderly Patients with Parkinson's Disease,” Clinical Neuropharmacology, Nov. 2004, 27:270-3. [cited by applicant]
Fincher, “Particle Size of Drugs and its Relationship to Absorption and Activity,” Journal of Pharmaceutical Sciences, 1968, 57:1825-35. [cited by applicant]
Actavis Laboratories FL, Inc., Notification of Certification for U.S. Pat. Nos. 9,089,607 and 9,089,608 Pursuant to § 505(j)(2)(B)(ii) of the Federal Food, Drug, and Cosmetic Act, Aug. 13, 2015. [cited by applicant]
Actavis Laboratories FL, Inc., Notification of Certification for U.S. Pat. Nos. 8,377,474; 8,557,283; 8,454,998; and 7,094,427 Pursuant to § 505(j)(2)(B)(ii) of the Federal Food, Drug, and Cosmetic Act, Aug. 4, 2015. [cited by applicant]
Impax Laboratories, Inc., Complaint against Actavis Laboratories FL, Inc. and Actavis Pharma Inc., Action for Patent Infringement under the Food and Drug Laws and Patent Laws of the United States, Sep. 17, 2015. [cited by applicant]
Mark, et al., “Controlled-Release Carbidopa-Levodopa (Sinemet) in Combination with Standard Sinimet in Advanced Parkinson's Disease,” 19 Annals Clinical Laboratory Sci. vol. 19, No. 2, 101-106(1989). [cited by applicant]
Hoffman, et al., “Pharmacokinetic and Pharmacodynamic Aspects of Gastroretentive Dosage Forms,” Intl. J. of Pharmaceutics, 227, 141-153. (2004). [cited by applicant]
Yeh, et al., “Pharmacokinetics and Bioavailability of Sinimet CR; A Summary of Human Studies,” Neurology vol. 39, 25-38 (Supp. 2 1989). [cited by applicant]
Cedarbaum, et al., “A Pharmacokinetic and Pharmacodynamic Comparison of Sinemet CR (50/200) and Standard Sinimet (25/100),” 39 Neurology 38-44 (Supp. 2 1989). [cited by applicant]
Grahnen, et al., “Comparative Multiple-Dose Pharmacokinetics of Controlled-Release Levodopa Products,” 32 European Neurology 343-348 (1992). [cited by applicant]
Young, Rosabel, “Update on Parkinson's Disease,” 59 American Family Physician vol. 59, 2155-2167 (1999). [cited by applicant]
Sasahara, et al., “Dosage Form Design for Improvement of Bioavailability of Levodopa II: Bioavailability of Marketed Levodopa Preparations in Dogs and Parkinsonian Patients,” Journal of Pharmaceutical Sciences, 69(3), 2… [cited by applicant]
Klausner, et al., “Novel Levodopa Gastroretentive Dosage Form: In-Vivo Evaluation in Dogs,” J. Controlled Release, 88, 117-126 (2003). [cited by applicant]
Klausner, et al., “Novel Gastroretentive Dosage Form: Evaluation of Gastroretentivity and its Effect on Levodopa Absorption in Humans,” Pharm. Res., 20(9), 1466-1473 (2003). [cited by applicant]
Sandoz Notification pursuant to Section 505 (j) (2) (B) (iv) of the Federal Food Drug and Cosmetic Act, Feb. 14, 2017. [cited by applicant]
Akhgari et al. “Statistical Optimization of Indomethacin Pellets Coated with pH-Dependent Methacrylic Polymers for Possible Colonic Drug Delivery.” International Journal of Pharmaceutics, 305:22-30 (2005). [cited by applicant]
Badawy, et al., “Microenvironmental pH Modulation in Solid Dosage Forms.” Journal of Pharmaceutical Sciences, vol. 96, No. 5, 948-59 (2007). [cited by applicant]
Bredenberg et al., “An Automatic Dose Dispenser for Microtablets—A New Concept for Individual Dosage of Drugs in Tablet Form.” International Journal Pharmaceutics, 261:137-146 (2003). [cited by applicant]
Cedarbaum, “Clinical Pharmacokinetics of Anti-Parkinsonian Drugs.” Clinical Pharmacokinetics, 13(3): 141-178 (1987). [cited by applicant]
Cedarbaum, “The Promise and Limitations of Controlled-Release Oral Levodopa Administration.” Clinical Neuropharmacology, 12(3): 147-166 (1989). [cited by applicant]
Chourasia, et al. “Pharmaceutical Approaches to Colon Targeted Drug Delivery Systems.” Journal of Pharmacy and Pharmaceutical Sciences, 6(1); 33-66 (2003). [cited by applicant]
Cole et al., “Enteric Coated HPMC Capsules Designed to Achieve Intestinal Targeting.” International Journal Pharmaceutics, 231(1): 83-95 (2002). [cited by applicant]
Contin et al., “Pharmacokinetic Optimisation in the Treatment of Parkinson's Disease.” Clinical Pharmacokinetics, Jun. 30(6): 463-481 (1996). [cited by applicant]
Crevoisier et al., “Bioavailability of L-Dopa after Madopar HBS Administration in Healthy Volunteers.” European Neurology, 27 (Suppl. 1): 36-46 (1987). [cited by applicant]
Crevoisier et al., “Comparative Single- and Multiple-Dose Pharmacokinetics of Levodopa and 3-O-Methyldopa Following a New Dual-Release and a Conventional Slow-Release Formulation of Levodopa and Benserazide in Healthy V… [cited by applicant]
Dave et al., “Expression of Heteromeric Amino Acid Transporters along the Murine Intestine.” J Physiol 558.2, 597-610 (2004). [cited by applicant]
Dingemanse, et al. “Pharmacokinetic Studies with a Dual-Release Formulation of Levodopa, a Novel Principle in the Treatment of Parkinson's Disease.” European Neurology, 39(2): 119-124 (1998). [cited by applicant]
Espinoza et al., “Influence of Admixed Citric Acid on the Release Profile of Pelanserin Hydrochloride from HPMC Matrix Tablets.” International Journal Pharmaceutics, 201(2): 165-173 (2000). [cited by applicant]
Gomes, et al., “Na+ Independent Transporters, LAT-2 and B0,+, Exchange L-DOPA with Neutral and Basic Amino Acids in Two Clonal Renal Cell Lines.” Journal Membrane Biology, 186(2): 63-80 (2002). [cited by applicant]
Gomes, et al., “L-DOPA Transport Properties in an Immortalised Cell Line of Rat Capillary Cerebral Endothelial Cells, RBE 4.” Brain Research, 829 (1-2): 143-150 (1999). [cited by applicant]
Goole et al., “Developmental and Evaluation of New Multiple-Unit Levodopa Sustained-Release Floating Dosage Forms.” International Journal of Pharmaceutics, 334(1-2): 35-41 (2007). [cited by applicant]
Goole et al., “Evaluation and Floating Enhancement of Levodopa Sustained Release Floating Minitablets Coated with Insoluble Acrylic Polymer.” Drug Development and Industrial Pharmacy, 34(8): 827-833 (2008). [cited by applicant]
Guthmann et al., “Development of a Multiple Unit Pellet Formulation for a Weakly Basic Drug.” Drug Development and Industrial Pharmacy, 33(3): 341-349 (2007). [cited by applicant]
Horter, et al., “Influence of Physicochemical Properties on Dissolution of Drugs in the Gastrointestinal Tract.” Advance Drug Delivery Reviews, 46(1-3): 75-87 (2001). [cited by applicant]
Iida, et al., “Improvement of Intestinal Absorption of P-glycoprotein Substrate by D-Tartaric Acid.” Drug Metabolism and Pharmacokinetics, 21(5): 424-428 (2006). [cited by applicant]
Jenner, “Avoidance of Dyskinesia: Preclinical Evidence for Continuous Dopaminergic Stimulation.” Neurology, 62 (Suppl. 1): S47-55 (2004). [cited by applicant]
Kendall, et al., “The Role of Polymers in Solid Oral Dosage Forms.” Polymers in Drug Delivery, 35-48 (Ijeoma F. Uchebbo and Andres G. Schatzlein eds., 2006). [cited by applicant]
Khor, et al., “The Pharmacokinetics and Pharmacodynamics of Levodopa in the Treatment of Parkinson's Disease.” Current Clinical Pharmacology, 2(3): 234-243 (2007). [cited by applicant]
Knop, et al., “Pharmaceutical Pellets.” ExAct, No. 15 (Nov. 2005). [cited by applicant]
Kranz, et al., “Development of a Single Unit Extended Release Formulation for Zk 811 752, a Weakly Basic Drug.” European Journal of Pharmaceutics Sciences, 26(1): 47-53 (2005). [cited by applicant]
Lees, “The On-Off Phenomenon.” Journal of Neurology, Neurosurgery, and Psychiatry, Special Supplement 29-37 (1989). [cited by applicant]
Lewitt, “Clinical Studies with and Pharmacokinetic Considerations of Sustained-Release Levodopa.” Neurology, 42 (Suppl. 1): 29-32 (1992). [cited by applicant]
Lewitt, “Levodopa Therapeutics: New Treatment Strategies.” Neurology, 43 (Suppl. 6): S31-37 (1993). [cited by applicant]
Li et al., “Enteric-Coated Layered Double Hydroxides as a Controlled Release Drug Delivery System.” International Journal of Pharmaceutics, 287(1-2): 89-95 (2004). [cited by applicant]
Lorenzo-Lamosa et al., “Design of Microencapsulated Chitosan Microspheres for Colonic Drug Delivery.” Journal of Control Release, 52 (1-2): 109-118 (1998). [cited by applicant]
MacMahon et al., “A Comparison of the Effects of Controlled-Release Levodopa (Madopar CR) with Conventional Levodopa in late Parkinson's Disease.” Journal of Neurology, Neurosurgery, and Psychiatry, 53(3): 220-223 (1990… [cited by applicant]
Malcom et al., “Single-Dose Pharmacokinetics of Madopar HBS in Patients and Effect of Food and Antacid on the Absorption of Madopar HBS in Volunteers,” European Neology, 27 (Suppl. 1): 28-35 (1987). [cited by applicant]
FDA Bioequivalence Review for ANDA 75-091 (1998). [cited by applicant]
Nyholm, et al., “Levodopa Infusion Therapy in Parkinson Disease: State of the Art in 2004.” Clinical Neuropharmacology, 27(5): 245-256 (2004). [cited by applicant]
Nyholm, “Pharmacokinetic Optimisation in the Treatment of Parkinson's Disease: An Update.” Clinical Pharmacokinetics, 45(2): 109-136 (2006). [cited by applicant]
Nyholm et al., “Optimizing Levodopa Pharmacokinetics: Intestinal Infusion Versus Oral Sustained-Release Tablets.” Clinical Neuropharmacology, 26(3): 156-163 (2003). [cited by applicant]
Nykanen et al., “Citric Acid as Excipient in Multiple Unit Enteric-Coated Tablets for Targeting Drugs on the Colon.” International Journal Pharmaceuticas, 229(1-2): 155-162 (2001). [cited by applicant]
Ogawa, “Factors Affecting Levodopa Effects in Parkinson's Disease.” Acta Med Okayama, 54(3): 95-101 (2000). [cited by applicant]
Pinho et al., “Over Expression of Renal LAT1 and LAT2 and Enhanced LDOPA Update in SHR Immortalized Renal Proximal Tubular Cells.” Kidney International, 66(1): 216-226 (2004). [cited by applicant]
Poewe et al., “Treatment of Motor Fluctuations in Parkinson's Disease with an Oral Sustained-Release Preparation of L-Dopa: Clinical and Pharmacokinetic Observations.” Clinical Neuropharmacology, 9(5): 430-439 (1986). [cited by applicant]
Quinones et al., “The Dopamine Precursor L-Dihydroxyphenylalanine is Transported by the Amino Acid Transporters rBAT and LAT2 in Renal Cortex.” American Journal of Physiology Renal Physiology, 287(1): F74-80 (2004). [cited by applicant]
Rao et al., “Parkinson's Disease: Diagnosis and Treatment.” American Family Physician, 74(12): 2047-2054 (2006). [cited by applicant]
Scattergood et al., “Comparative Study of Theoretical Versus Actual Weight Gain for a Surelease® Barrier Membrane on Coated Pellets.” www.colorcon.com, mr/poster/SureSpheres/stud_comp_wt_gain_REV/Rev1.2009 (2004). [cited by applicant]
Seipe et al., “Strategies for the Design of Hydrophilic Matrix Tablets with Controlled Microenvironmental pH.” International Journal of Pharmaceutics, 316 (1-2): 14-20 (2006). [cited by applicant]
Simon et al., “The Effects of a Normal Protein Diet on Levodopa Plasma Kinetics in Advanced Parkinson's Disease.” Parkinsonism Related Disorders, 10(3): 137-142 (2004). [cited by applicant]
Sinemet® Package Insert, 2002. [cited by applicant]
Tang et al., “Coating of Multiparticulates for Sustained Release.” American Journal of Drug Delivery, 3(1): 17-28 (2005). [cited by applicant]
“Treatment of Early Parkinson's Disease.” American Family Physician, 72(3): 497-500 (2005), http://aafp.org/afp/2005/0801/p497.html. [cited by applicant]
HSU Declaration, Under 37 C.F.R. 1.132 (Sep. 24, 2012). [cited by applicant]
Bettini et al. “Influence of Layer Position on In Vitro and In Vivo Release of Levodopa Methyl Ester and Carbidopa from Three-Layer Matrix Tablets,” European Journal of Pharmaceutics and Biopharmaceutics, 53:227-232 (20… [cited by applicant]
Deleu, et al., “Clinical and Pharmacokinetic Comparison of Oral and Dodental Delivery of Levodopa/Carbidopa in Patients with Parkinson's Disease with a Fluctuating Response to Levodopa,” European Journal of Clinical Pha… [cited by applicant]
Pahwa et al., “Early Morning Akinesia in Parkinson's Disease: Effect of Standard Carbidopa/Levodopa and Sustained-Release Carbidopa/Levodopa,” Neurology, 46: 1059-1062 (1996). [cited by applicant]
Pahwa et al., “Comparison of Standard Carbidopa-Levodopa and Sustained-Release Carbidopa-Levodopa in Parkinson's Disease: Pharmacokinetic and Quality of Life Measures,” Movement Disorders, 12:677-681 (1997). [cited by applicant]
Kurlan et al., “Duodenal and Gastric Delivery of Levodopa in Parkinsonism,” Annals of Neurology, 23:589-595 (1988). [cited by applicant]
Kurlan et al., “Erratic Gastic Emptying of Lvodopa May Cause Random Fluctuations of Parkinsonian Mobility,” Neurology, 38:419-421 (1988). [cited by applicant]
Baruzzi et al., “Influence of Meal Ingestion Time on Pharmacokinetics of Orally Administered Levodopa in Parkinsonian Patients,” Clinical Neuropharmacolgy, 10:527-537 (1987). [cited by applicant]
Sinemet® CR Package Insert, Jan. 2011. [cited by applicant]
Rytary® Package Insert, Jan. 2015. [cited by applicant]
Stalevo® Package Insert, Sep. 2010. [cited by applicant]
FDA Draft Guidance for Carbidopa Levodopa Extended Release Capsule Sep. 2015. [cited by applicant]
Yao, et al. “Clinical Pharmacokinetics of IPX066: Evaluation of Dose Proportionality and Effect of Food in Healthy Volunteers,” Clinical Neuropharmacol., 29:10-17 (2016). [cited by applicant]
Hsu, et al., “Comparison of the Pharmacokinetics of an Oral Extended-Release Capsule Formulation of Carbidopa- Levodopa (IPX066) with Immediate-Release Carbidopa-Levodopa (Sinemet®), Sustained-Release Carbidopa-Levodopa… [cited by applicant]
Brooks, “Optimizing Levodopa Therapy for Parkinson's Disease with Levodopa/Carbidopa/Entacapone: Implications from a Clinical and Patient Perspective,” Neuropsychiatr Dis Treat 4:39-47 (2008). [cited by applicant]
Chana, et al., “Delayed Early Morning Turn “ON” in Response to a Single Dose of Levodopa in Advanced Parkinson's Disease: Pharmacokinetics Should be Considered,” J. Neurol Neurosurg Psychiaty 75:1782-1783 (2004). [cited by applicant]
Hauser, “Levodopa: Past, Present, and Future,” Eur. Neurol. 62:1-8 (2009). [cited by applicant]
Kempster et al., “Levodopa Peripheral Pharmacokinetics and Duration of Motor Response in Parkinson's Disease,” J. Neurol Neurosurg Psychiatry, 52:718-723 (1989). [cited by applicant]
Mao et al., “Population Pharmacodynamics of IPX066: An Oral Extended-Release Capsule Formulation of Carbidopa-Levodopa, and Immediate-Release Carbidopa-Levodopa in Patients with Advanced Parkinson's Disease,” J. Clin. P… [cited by applicant]
Fahn, “Parkinson Disease, the Effect of Levodopa and the ELLDOPA Trial, Earlier vs Later L-DOPA,” Arch Neurol. 56 (5):529-535 (1999). [cited by applicant]
Stocchi, et al., “Intermittent vs Continuous Levodopa Administration in Patients with Advanced Parkinson Disease: a Clinical and Pharmacokinetic Study,” Arch Neurol. 62(6):905-910 (2005). [cited by applicant]
Goetz, et al., “Handling Missing Values in the NDS-UPDRS,” Mov. Disord. 30(12):1632-1638 (2015). [cited by applicant]
Modi, et al., “Single-Dose Pharmacokinetics and Pharmacodynamics of IPX203 in PatientsWith Advanced Parkinson Disease: A Comparison with Immediate-Release Carbidopa-Levodopa and with Extended-Release Carbidopa-Levodopa … [cited by applicant]
Chen, et al., “Pharmacokinetics and Pharmacodynamics of Gastroretentive Delivery of Levodopa/Carbidopa in Patients with Parkinson Disease,” Clin Neuropharmacol 35:67-72 (2012). [cited by applicant]
Hauser, et al., “Crossover Comparison of IPX066 and a Standard Levodopa Formulation in Advanced Parkinson's Disease,” Mov. Disord, 26:2246-2252 (2011). [cited by applicant]
Stacy et al., “Motor Effects and Safety of IPX203, an Investigational Extended-Release Formulation of Carbidopa-Levodopa, in Advanced Parkinson's Disease: A Single-Dose Phase 2 Study,” Aug. 21, 2017. [cited by applicant]
Stacy et al., “Motor Effects and Safety of IPX203, an Investigational Extended-Release Formulation of Carbidopa-Levodopa, in Advanced Parkinson's Disease: A Single-Dose Phase 2 Study,” Neurology, 2017; 89, e99 (2017 Eme… [cited by applicant]
Impax Laboratories, “Impax Laboratories (IPXL) to Present Data on Neurology Development Programs at AAN” StreetInsider.com, Apr. 21, 2017. [cited by applicant]
Pena, “IPX203 Extended-Release Capsules Reduce ‘Off’ Time In Advanced Parkinson's,” parkinsonsnewtoday.com/2019/07/18/ipx203-extended-release-capsules-reuced-off-time-advanced-parkinsons/ Jul. 18, 2019. [cited by applicant]
Modi et al., “Pharmacodynamics, Efficacy, and Safety of IPX203 in Parkinson Disease Patients With Motor Fluctuations,” Clinical Neuropharmacology, 42(5) pp. 149-156 Sep. 2019 (published on line Jul. 12, 2019). [cited by applicant]
Mittur et al., “Multiple-Dose Pharmacodynamics of IPX203,” Annals of Neurology, vol. 84 (suppl 22) 2018, S324LBA (abstract presented during the 143 rd Annual Meeting of American Neurological Association Oct. 21-23, 2018… [cited by applicant]
Impax Laboratories, LLC, “An Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients with Motor Fluctuations,” Clinicaltrialsreg… [cited by applicant]
Impax Laboratories, LLC, “An Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients with Motor Fluctuations,” Clinicaltrialsreg… [cited by applicant]
Impax Laboratories, LLC, “An Open-Label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients with Motor Fluctuations,” Clinicaltrialsregister.eu, EudraCT No. 2018-002234-21 (Spain… [cited by applicant]
Decision in Opposition Proceedings for European Patent No. 3 054 929 dated Nov. 18, 2022. [cited by applicant]
Notice of Opposition to Columbian Patent Application No. NC20230009085 dated Nov. 29, 2023. [cited by applicant]
Mao et al., “Dose-Response Analysis of the Effect of Carbidopa-Levodopa Extended-Release Capsules (IPX066) in Levodopa-Naïve Patients with Parkinson Disease,” J. Clin. Pharm. 2016; 56: 974-82. [cited by applicant]
Clinical Trial NCT00880620, “A Study to Evaluate the Safety and Efficacy of IPX066 in Subjects With Parkinson's Disease” Oct. 25, 2019. [cited by applicant]
LeWitt et al., et al., “Pharmacokinetic-Pharmacodynamic Crossover Comparison of Two Levodopa Extension Strategies,” Mov. Disord. 2009; 24: 1319-24 (LeWitt). [cited by applicant]
Nyholm, et al., “Frequent Administration of Levodopa/Carbidopa Microtablets vs. Levodopa/Carbidopa/Entacapone in Healthy Volunteers,” Acta Neurol. Scand. 2013: 127:124-32. [cited by applicant]
Waters et al.,“Long-Term Treatment With Extended-Release Carbidopa-Levodopa (IPX066) in Early and Advanced Parkinson's Disease: a 9-Month Open-Label Extension Trial,” CNS drugs. Apr. 2015;29:341-50. [cited by applicant]
Pahwa et al., “Randomized Trial of IPX066, Carbidopa/Levodopa Extended Release, in Early Parkinson's Disease,” Parkinsonism & Related Disorders. Feb. 1, 2014;20(2):142-8. [cited by applicant]
Hauser et al., “Extended-Release Carbidopa-Levodopa (IPX066) Compared with Immediate-Release Carbidopa-Levodopa in Patients with Parkinson's Disease and Motor Fluctuations: a Phase 3 Randomised, Double-Blind Trial,” The… [cited by applicant]
Espay et al., “Optimizing Extended-Release Carbidopa/Levodopa in Parkinson Disease: Consensus on Conversion From Standard Therapy,” Neurology: Clinical Practice. Feb. 2017;7(1):86-93. [cited by applicant]
European Patent Application Publication No. 4267113 (application No. 21912079.7) Supplemental Search Report Oct. 23, 2024. [cited by applicant]
Obenewaa et al., “Chitosan-Coated Hydroxypropylmethyl Cellulose Microparticles of Levodopa (and Carbidopa): In Vitro and Rat Model Kinetic Characteristics,” Current Therapeutic Research, Excerpta Medica, vol. 93, Jan. 1… [cited by applicant]
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US 12,691,074