IP Library › Granted Patent US 12,702,659
Granted Patent B2
US 12,702,659 · App. 17/763,615 · Granted Aug 11, 2026

Rifaximin liquid formulations

Inventors: Arturo J. Angel (Santa Rosa, CA); Kasturi R. Pawar (Rohnert Park, CA); Radhakrishnan S. Pillai (Santa Rosa, CA)
Assignee: Bausch Health Ireland Limited
A61K31/437A61K9/4825A61K9/4858A61K9/4866A61P31/04
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Quick Facts
Patent No.
US 12,702,659
App. No.
17/763,615
Filed
Mar 24, 2022
Granted
Aug 11, 2026
Kind
B2
Art Unit
1627
USPC
514/279
Abstract

Provided herein are pharmaceutical compositions which enhance the intestinal levels of soluble rifaximin, formulations comprising said compositions, and their use in treating one or more bowel related disorders.

Claims (34)

1 . A pharmaceutically acceptable composition comprising rifaximin, a hydrogenated castor oil in an amount ranging from about 25% to about 65% by weight of the composition, and at least one additional solubilizing excipient comprising a combination of castor oil, glyceryl caprylate, and polysorbate 80.

2 . The composition of claim 1 , wherein the hydrogenated castor oil is polyoxyl 60 hydrogenated castor oil or polyoxyl 40 hydrogenated castor oil.

3 . The composition of claim 1 , wherein the at least one additional solubilizing excipient further comprises polyethylene glycol 600, benzyl alcohol, polyethylene glycol 400, diethylene glycol monoethyl ether, glyceryl monooleate, triethylene glycol, diisopropyl adipate, diethyl sebacate, olelyl alcohol, polysorbate 20, oleic acid, caprylic capric triglycerides, propylene glycol, sesame oil, soybean oil, and corn oil, and combinations thereof.

4 . The composition of claim 1 , wherein the at least one additional solubilizing excipient is present in an amount ranging from about 45% to about 65% by weight of the composition.

5 . The composition of claim 1 , wherein

the castor oil is present in an amount ranging from about 5% to about 15% by weight of the composition;

the glyceryl caprylate is present in an amount ranging from about 5% to about 15% by weight of the composition; and

the polysorbate 80 is present in an amount ranging from about 20% to about 40% by weight of the composition.

6 . The composition of claim 1 , wherein

the castor oil is present in an amount ranging from about 10% to about 20% by weight of the composition;

the glyceryl caprylate is present in an amount ranging from about 5% to about 15% by weight of the composition; and

the polysorbate 80 is present in an amount ranging from about 20% to about 40% by weight of the composition.

7 . The composition of claim 1 , wherein

the castor oil is present in an amount ranging from about 5% to about 15% by weight of the composition;

the glyceryl caprylate is present in an amount ranging from about 10% to about 15% by weight of the composition; and

the polysorbate 80 is present in an amount ranging from about 35% to about 45% by weight of the composition.

8 . The composition of claim 1 , wherein the at least one additional solubilizing excipient further comprises a combination of diethyl sebacate and diethylene glycol monoethyl ether.

9 . The composition of claim 8 , wherein

the diethyl sebacate is present in an amount ranging from about 20% to about 35% by weight of the composition; and

the diethylene glycol monoethyl ether is present in an amount ranging from about 20% to about 35% by weight of the composition.

10 . The composition of claim 8 , wherein

the diethyl sebacate is present in an amount ranging from about 10% to about 20% by weight of the composition; and

the diethylene glycol monoethyl ether is present in an amount ranging from about 30% to about 45% by weight of the composition.

11 . The composition of claim 1 , wherein the composition further comprises an antioxidant and/or a chelating agent.

12 . The composition of claim 1 , wherein the composition further comprises one or more of butylated hydroxytoluene (BHT) and citric acid, each in an amount ranging from about 0.01% to about 0.1% by weight of the composition.

13 . The composition of claim 1 , wherein the composition further comprises one or more of butylated hydroxytoluene (BHT), citric acid, and ascorbyl palmitate, each in an amount ranging from about 0.05% to about 0.15% by weight of the composition.

14 . The composition of claim 1 , wherein the rifaximin is present in an amount ranging from about 1.0% to about 15% by weight of the composition.

15 . The composition of claim 1 , wherein the rifaximin is present in an amount ranging from about 1% to about 5% by weight of the composition.

16 . The composition of claim 1 , wherein the rifaximin is present in an amount of about 2.5% by weight of the composition.

17 . The composition of claim 1 , wherein the total amount of rifaximin in the composition ranges from about 1 mg to about 50 mg.

18 . The composition of claim 1 , wherein the composition comprises about 10% rifaximin, about 10% castor oil, about 12% glyceryl caprylate, about 33% polysorbate 80, and about 35% polyoxyl 40 hydrogenated castor oil, by weight of the composition.

19 . The composition of claim 1 , wherein the composition comprises about 5% rifaximin, about 15% castor oil, about 12% glyceryl caprylate, about 33% polysorbate 80, and about 35% polyoxyl 40 hydrogenated castor oil, by weight of the composition.

20 . The composition of claim 1 , wherein the composition comprises about 2.5% rifaximin, about 10% castor oil, about 12% glyceryl caprylate, about 40% polysorbate 80, and about 35% polyoxyl 40 hydrogenated castor oil, by weight of the composition.

21 . The composition of claim 1 , wherein the composition is a liquid composition.

Assignments (10)
U.S. PATENT SECURITY AGREEMENT Recorded Nov 25, 2025
From: BAUSCH HEALTH IRELAND LIMITED
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 073715/0375 →
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH, CANADA INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
Reel/Frame 073654/0300 →
RELEASE OF SECURITY INTEREST Recorded Apr 8, 2025
From: BARCLAYS BANK PLC, AS COLLATERAL AGENT
To: SOLTA MEDICAL, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH IRELAND LIMITED (F/K/A/ VALEANT PHARMACEUTICALS IRELAND LIMITED); SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD; SANTARUS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; HUMAX PHARMACEUTICAL S.A.; SOLTA MEDICAL IRELAND LIMITED; BAUSCH & LOMB MEXICO, S.A. DE C.V.; BAUSCH+LOMB OPS B.V.; BAUSCH HEALTH AMERICAS, INC.; BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH HOLDCO LIMITED; BAUSCH HEALTH MAGYARORSZAG KFT (A/K/A BAUSCH HEALTH HUNGARY LLC); BAUSCH HEALTH POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA (F/K/A VALEANT PHARMA POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA); BAUSCH HEALTH US, LLC; BAUSCH HEALTH, CANADA INC. / SANTE BAUSCH, CANADA INC.; ICN POLFA RZESZOW SPOLKA AKCYJNA (A/K/A ICN POLFA RZESZOW S.A.); ORAPHARMA, INC.; PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA SPOLKA AKCYJNA (A/K/A PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA S.A.); SOLTA MEDICAL DUTCH HOLDINGS B.V.; V-BAC HOLDING CORP.; VRX HOLDCO LLC; 1261229 B.C. LTD.; 1530065 B.C. LTD.
Reel/Frame 070778/0199 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Feb 24, 2023
From: BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 062853/0655 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 23, 2023
From: ANGEL, ARTURO J.; PAWAR, KASTURI R.; PILLAI, RADHAKRISHNAN S.
To: BAUSCH HEALTH IRELAND LIMITED
Reel/Frame 062788/0412 →
SECURITY AGREEMENT (FIRST LIEN) Recorded Nov 4, 2022
From: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061882/0708 →
SECURITY AGREEMENT (SECOND LIEN) Recorded Nov 4, 2022
From: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 062078/0276 →
SECURITY AGREEMENT (SECOND LIEN) Recorded Oct 5, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061606/0468 →
SECURITY AGREEMENT (FIRST LIEN) Recorded Oct 4, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061595/0066 →
SECURITY INTEREST Recorded Jun 13, 2022
From: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH, CANADA INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON
Reel/Frame 060346/0705 →
Continuity (3)
Provisional Application 63044447 · Jun 26, 2020
Provisional Application 62904790 · Sep 24, 2019
Related Publication 20220378758A1 · Dec 1, 2022
References Cited (122)
US 4717569A · Harrison et al. · 1988 [cited by applicant]
US 5352679A · Ferrieri et al. · 1994 [cited by applicant]
US 6861053B1 · Lin et al. · 2005 [cited by applicant]
US 7915275B2 · Viscomi et al. · 2011 [cited by applicant]
US 8003118B2 · Kodsi · 2011 [cited by applicant]
US 8309569B2 · Forbes et al. · 2012 [cited by applicant]
US 8383151B2 · Jahagirdar et al. · 2013 [cited by applicant]
US 8946252B2 · Forbes et al. · 2015 [cited by applicant]
US 9133217B2 · Parent et al. · 2015 [cited by applicant]
US 10137114B2 · Jahagirdar et al. · 2018 [cited by applicant]
US 11779571B2 · Forbes et al. · 2023 [cited by applicant]
US 20040034021A1 · Michaelis · 2004 [cited by examiner]
US 20090028940A1 · Jahagirdar et al. · 2009 [cited by applicant]
US 20120196887A1 · Darkoh et al. · 2012 [cited by applicant]
US 20120214833A1 · Kulkarni et al. · 2012 [cited by applicant]
US 20130184302A1 · Bortey et al. · 2013 [cited by applicant]
US 20130210852A1 · DuPont et al. · 2013 [cited by applicant]
US 20140221414A1 · Kulkarni et al. · 2014 [cited by applicant]
US 20150164866A1 · Randall · 2015 [cited by applicant]
US 20160024051A1 · Genov et al. · 2016 [cited by applicant]
US 20160243144A1 · Garegnani et al. · 2016 [cited by applicant]
US 20170087134A1 · Golden · 2017 [cited by applicant]
US 20170333562A1 · Selbo et al. · 2017 [cited by applicant]
US 20180021297A1 · Hauser · 2018 [cited by applicant]
US 20180049979A1 · Zhao et al. · 2018 [cited by applicant]
US 20180243272A1 · Forbes et al. · 2018 [cited by applicant]
US 20190224175A1 · Golden · 2019 [cited by applicant]
US 20230027192A1 · Bajaj · 2023 [cited by applicant]
US 20230277447A1 · Cole et al. · 2023 [cited by applicant]
CN 101137350B · 2008 [cited by applicant]
CN 101502513A · 2009 [cited by applicant]
CN 102716168A · 2012 [cited by applicant]
CN 103118666A · 2013 [cited by applicant]
CN 103263523A · 2013 [cited by applicant]
CN 103263668A · 2013 [cited by applicant]
CN 105025717A · 2015 [cited by applicant]
CN 110290781A · 2019 [cited by applicant]
EP 2011486A1 · 2009 [cited by applicant]
EP 1996710B1 · 2019 [cited by applicant]
JP 2002537317A · 2022 [cited by applicant]
RU 2609833C2 · 2015 [cited by applicant]
WO 2003101445A1 · 2003 [cited by applicant]
WO WO03101445A1 · 2003 [cited by examiner]
WO 200473692A1 · 2004 [cited by applicant]
WO 2005030142A2 · 2005 [cited by applicant]
WO 2005044823A2 · 2005 [cited by applicant]
WO 2006094737A2 · 2006 [cited by applicant]
WO 2006094662A1 · 2006 [cited by applicant]
WO WO2007117556A2 · 2007 [cited by examiner]
WO 2008016708A2 · 2008 [cited by applicant]
WO 2009008005A1 · 2009 [cited by applicant]
WO 2010044093A1 · 2010 [cited by applicant]
WO 2010067072A1 · 2010 [cited by applicant]
WO 2011051971A2 · 2011 [cited by applicant]
WO 2012035283A1 · 2012 [cited by applicant]
WO 2012103119A1 · 2012 [cited by applicant]
WO 2006112541A1 · 2013 [cited by applicant]
WO 2014006576A1 · 2014 [cited by applicant]
WO 2016014437A1 · 2016 [cited by applicant]
WO 2016140952A1 · 2016 [cited by applicant]
WO 2017205302A1 · 2017 [cited by applicant]
WO 2018064472A1 · 2018 [cited by applicant]
WO 2018165404A1 · 2018 [cited by applicant]
Hecht et al., In Vitro Activities of 15 Antimicrobial Agents against 110 Toxigenic Clostridium difficile Clinical Isolates Collected from 1983 to 2004, Antimicrob Agents Chemother. May 21, 2007;51(8):2716-2719. [cited by examiner]
Office Action issued in corresponding Mexican Application No. MX/a/2022/003481 dated Oct. 18, 2024, 12 pages. [cited by applicant]
Office Action issued in Russian Patent Application No. 2022110800, dated Jan. 23, 2024, 26 pages. [cited by applicant]
Arya et al. Rifaximin—the promising anti-microbial for enteric infections. J Infect. 51(3): 262, Abstract only (2005). [cited by applicant]
Cober et al. Stability of extemporaneously prepared rifaximin oral suspensions. Am J Health Syst Pharm. 67(4):287-9 (2010). [cited by applicant]
Office Action issued in European Patent Application No. 21739302.4, dated Jun. 13, 2024, 11 pages. [cited by applicant]
Office Action issued in Chinese Patent Application No. 202180052294.0, dated Mar. 27, 2024, 30 pages. [cited by applicant]
Kornbluth Asher et al.: “Efficacy and Safety of Rifaximin in the Treatment of Mild-Moderate Crohn's Disease: Results of An Ope⋅⋅Label Pilot Study”, Gastroenterology, vol. 128, No. 4 Suppl 2, Apr. 1, 2005, pp. A-579, XP9… [cited by applicant]
Office Action issued in Japanese Patent Application No. 2022-518665, mailed Oct. 1, 2024, 9 pages. [cited by applicant]
Lu Bin, People's Health Publishing House, New Techniques and New Dosage Forms of Drugs, 2nd version in Jul. 2005, date of publication: May 31, 2005, pp. 51-53. [cited by applicant]
Office Action issued in European Patent Application No. 19163419.5, dated Mar. 13, 2024, 6 pages. [cited by applicant]
Prantera et al: “Antibiotic treatment of Crohn's disease: results of a multicentre, double blind, randomized, placebo⋅ controlled trial with rifaximin”, Alimentary Pharmacology & Therapeutics, Blackwell Scientific Publi… [cited by applicant]
Office Action issued in U.S. Appl. No. 18/628,353, dated Aug. 22, 2024, 14 pages. [cited by applicant]
Office Action issued in U.S. Appl. No. 18/628,366, dated Sep. 17, 2024, 16 pages. [cited by applicant]
Kornbluth Asher: “Efficacy and Safety of Open Label Rifaximin in the Treatment of Mild-Moderate Crohn's Disease (CD) Refractory to Multiple Medical Therapies”, American College of Gastroenterology, vol. 111, Sep. 1, 200… [cited by applicant]
Sharara et al., A Randomized Double-Blind Placebo-Controlled Trial of Rifaximin in Patients with Abdominal Bloating and Flatulence, Am J Gastroenterol, 101:326-333, 2006. [cited by applicant]
Scarpignato, Rifaximin, a Poorly Absorbed Antibiotic: Pharmacology and Clinical Potential, Chemotherapy, 51(suppl 1):36-66, 2005. [cited by applicant]
Marchina et al., Infectious diarrhea in the aged: controlled clinical trial of Rifaximin, Chemioterapia, 7(5):336-40, 1988. [cited by applicant]
Nikolett Kallai et al: “Evaluation of Drug Release From Coated Pellets Based on Isomalt, Sugar, and Microcrystalline Cellulose Inert Cores”, AAPS Pharmscitech, vol. 11, No. 1, Mar. 1, 2010, pp. 383-391, XP055024443, ISS… [cited by applicant]
Bhavik Solanki et al: “Multiple Unit Dosage Forms: a Review”, Pharmtechmedica, vol. 1, No. 1, Jan. 1, 2012, pp. 11-21, XP055235562. [cited by applicant]
Lim Seah H. et al: “Rifaximin for sickle cell disease”, American Journal of Hematology vol. 94, No. 12 Oct. 7, 2019, XP055816244, US ISSN: 0361-8609, DOI: 10.1002/ajh.25637 Retrieved from the Internet: URL:https://onlin… [cited by applicant]
Viscomi G C et al: “Crystal forms of rifaximin and their effect on pharmaceutical properties”, Crystengcomm, Royal Society of Chemistry, Cambridge, GB, vol. 10, Jan. 1, 2008, pp. 1074-1081, XP009152378, ISSN: 1466-8033,… [cited by applicant]
Carmelo Scarpignato et al.: “Impact of crystal polymorphism on the systemic bioavailability of rifaximin, an antibiotic acting locally in the gastrointestinal tract, in healthy volunteers”, Drug Design, Development and … [cited by applicant]
Siepmann et al: “Polymer blends for controlled release coatings”, Journal of Controlled Release, Elsevier, Amsterdam, NL, vol. 125, No. 1, Oct. 13, 2007, pp. 1-15, XP022375058, ISSN: 0168-3659, DOI: 10.1016/J.JCONREL.20… [cited by applicant]
Office Action issued in Brazilian Patent Application No. BR112022003500-4, dated Sep. 3, 2024, 5 pages. [cited by applicant]
Decision of Rejection issued in Chinese Patent Application No. 202080067056.2, dated Sep. 9, 2024, 21 pages. [cited by applicant]
Office Action issued in Chinese Patent Application No. 202180052294.0, dated Nov. 6, 2024, 18 pages. [cited by applicant]
Office Action issued in U.S. Appl. No. 18/012,362, dated Feb. 12, 2025, 12 pages. [cited by applicant]
Office Action issued in European Patent Application No. 20785690.7, dated Apr. 17, 2024, 7 pages. [cited by applicant]
Office Action issued in Chinese Patent Application No. 202080067056.2, dated Apr. 26, 2024, 12 pages. [cited by applicant]
Decision on Grant issued in Russian Patent Application No. 2022110800, dated Jul. 1, 2024, 25 pages. [cited by applicant]
Decision on Rejection issued in Chinese Patent Application No. 202080067056.2, dated Sep. 9, 2024, 21 pages. [cited by applicant]
Office Action issued in Canadian Patent Application No. 3, 151,010, dated Nov. 14, 2023, 5 pages. [cited by applicant]
International Search Report and Written Opinion issued in PCT/EP2020/076746, dated Jan. 12, 2021, 13 pages. [cited by applicant]
Omez® DSR Label (LP-003998-061216. Dec. 6, 2016). State Register of Medicines [online] [retrieved Aug. 31, 2023]. Found on <https://grls.rosminzdrav.ru/Instrlmg/2016/12/13/1413974/%D0%9B%D0%9F- 003998[2016]_0.pdf>, 27 p… [cited by applicant]
Office Action issued in Eurasian Patent Application No. 202390175, dated May 22, 2025, 10 pages. [cited by applicant]
Office Action issued in Japanese Patent Application No. 2022-580309, mailed Jul. 15, 2025, 7 pages. [cited by applicant]
Office Action issued in Canadian Patent Application. No. 3,151,010, dated Sep. 5, 2025, 3 pages. [cited by applicant]
Office Action issued in Japanese Patent Application No. 2022-518665, dated Apr. 1, 2025, 9 pages. [cited by applicant]
Cosmetic Ingredient Information Online “PEG-60 Hydrogenated Castor Oil,” https://cosmetic-ingredients.org/surfactants-emulsifying-agents/2066/. [cited by applicant]
Office Action issued in Mexican Patent Application No. MX/a/2022/003481, dated Apr. 22, 2025, 12 pages. [cited by applicant]
Decision of Rejection issued in Chinese Patent Application No. 202180052294.0, dated Apr. 7, 2025, 31 pages. [cited by applicant]
Office Action issued in U.S. Appl. No. 17/779,865, dated Mar. 13, 2025, 25 pages. [cited by applicant]
Vlachogiannakos et al., “Long-term administration of rifaximin improves the prognosis of patients with decompensated alcoholic cirrhosis,” Journal of Gastroenterology and Hepatology, 2012, 450-455. [cited by applicant]
Office Action issued in corresponding Chinese Application No. 202180052294.0, dated Nov. 6, 2024, 18 pages. [cited by applicant]
Shayto, R.H, Mrad, R.A., and Sharara, A.I., Use of rifaximin in gastrointestinal and liver diseases, World Journal of Gastroenterology, 22, p. 6638-6651 (Year: 2016). [cited by applicant]
Calanni, F., Renzulli, C., Barbanti, M., and Viscomi, G.C., Rifaximin: beyond the traditional antibiotic acitivty, The Journal of Antibiotics, 67, p. 667-670 (Year: 2014). [cited by applicant]
Li, T. and Chiang, J.Y.L., Bile Acid Signaling in Metabolic Disease and Drug Therapy, Pharmacological Reviews, 66, p. 948-983 ( Year: 2014). [cited by applicant]
Hughes, J.P., Rees, S., Kalindjian, S.B., Philpott, K.L., Principles of early drug discovery, British Journal of Pharmacology, 162, p. 1239-1249 (Year: 2011). [cited by applicant]
Office Action issued in U.S. Appl. No. 18/241,355, dated Jan. 21, 2026, 15 pages. [cited by applicant]
Office Action issued in Australian Patent Application No. 2020355603, dated Aug. 22, 2025, 4 pages. [cited by applicant]
Office Action issued in U.S. Appl. No. 17/779,865, dated Sep. 19, 2025, 12 pages. [cited by applicant]
Bausch Health Americas, Inc., “Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess The Efficacy and Safety of Three Different Doses (275, 550 AND 1100 MG) of Rifaximin Administered BID For Either T… [cited by applicant]
Canadian preliminary appeal decision issued in Canadian Patent Application No. 2,716,578 dated Nov. 28, 2025, 28 pages. [cited by applicant]
Pimentel et al. “The Effect of a Nonabsorbed Oral Antibiotic (Rifaximin) on the Symptoms of Irritable Bowel Syndrome,” Annals of Internal Medicine, 2006, 145, pp. 557-563. [cited by applicant]
Press release by Salix Pharmaceuticals, Ltd., “Rifaximin Demonstrates Statistically Significant Improvement in Co-Primary Endpoints in Treatment of Diarrhea-Associated Irritable Bowel Syndrome in Phase IIb Study,” Sep. … [cited by applicant]
Examination Report issued in Australian Patent Application No. 2021298178, mailed Jun. 2, 2026, 5 pages. [cited by applicant]
Office Action issued in U.S. Appl. No. 17/779,865, dated Mar. 10, 2026, 10 pages. [cited by applicant]
Notice of Acceptance issued in Australian Patent Application No. 2020355603, dated Jan. 28, 2026, 3 pages. [cited by applicant]