Granted Patent
B2
US 12,390,431 · App. 16/693,312 · Granted Aug 19, 2025
Method of escalating sotalol hydrochloride dosing
Inventors:
John Charin Somberg (Chicago, IL); Brandon Ira Kashfian (Chicago, IL); Janos Molnar (Chicago, IL)
Assignee:
AltaThera Pharmaceuticals LLC
View Patent ↗
Loading inventors, assignments & file history…
Abstract
This disclosure provides a method of safely and rapidly initiating or escalating oral sotalol therapy by administering an intravenous dosage of sotalol followed by oral sotalol twice daily.
Claims (16)
1. A method of rapidly escalating a subject's oral sotalol hydrochloride therapy to a higher oral dose, the method comprising:
(1) identifying a subject as having symptomatic atrial fibrillation or atrial flutter, who is currently in sinus rhythm, who is under QTc monitoring, and who is receiving 120 mg oral sotalol hydrochloride therapy such that the subject has a concentration of sotalol resulting therefrom;
(2) escalating the concentration of sotalol of the subject to a higher concentration, by administering over a period of 1 hour, a single IV dosage of sotalol hydrochloride in an amount in the range of 99 mg to 105.6 mg and at a rate in the range of 1.65-1.76 mg/min; and
(3) after completion of the single IV dosage of sotalol hydrochloride, increasing the amount of the subject's oral dosing from 120 mg to 160 mg by administering at least one oral dose of 160 mg sotalol hydrochloride to the subject.
2. The method of claim 1 , further comprising repeating oral administration of the 160 mg oral dose of sotalol hydrochloride at least once at a selected interval.
3. The method of claim 2 , wherein the administering of the oral dose of 160 mg starts at about 4-12 hours after completion of the single IV dosage of sotalol hydrochloride.
4. The method of claim 3 , wherein the administering of the oral dose of 160 mg starts at about 4 hours after completion of the single IV dosage of sotalol hydrochloride.
5. The method of claim 1 , wherein:
the administering of the oral dose of 160 mg starts at about 6 hours after completion of the single IV dosage of sotalol hydrochloride.
6. The method of claim 5 , further comprising repeating oral administration of the 160 mg oral dose of sotalol hydrochloride at a selected interval, wherein the repeating of the oral administration is performed at least once.
7. The method of claim 1 , wherein:
the administering of the oral dose of 160 mg starts at about 4-12 hours after completion of the single IV dosage of sotalol.
8. The method of claim 7 , further comprising repeating oral administration of the 160 mg oral dose of sotalol hydrochloride at a selected interval, wherein the administering of the oral dose of 160 mg and the repeating of the oral administration is performed at least once and according to a once daily or twice daily schedule.
9. The method of claim 1 , wherein the subject received a 120 mg oral dose of sotalol hydrochloride 12-24 hours before administration of the single IV dose.
10. The method of claim 2 , wherein the administering of the oral dose of 160 mg and the repeating is performed according to a once or twice daily schedule.
11. The method of claim 3 , wherein the administering of the oral dose of 160 mg and the repeating is performed according to a once or twice daily schedule.
Assignments (3)
ASSIGNMENT OF SECURITY INTEREST IN PATENT COLLATERAL
Recorded Jul 14, 2023
From: SAGARD HEALTHCARE ROYALTY PARTNERS, LP
To: SAGARD HEALTHCARE PARTNERS (DELAWARE) LP
Reel/Frame 064275/0433 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 29, 2021
From: SOMBERG, JOHN CHARIN; KASHFIAN, BRANDON IRA; MOLNAR, JANOS
To: ALTATHERA PHARMACEUTICALS LLC
Reel/Frame 055820/0938 →
SECURITY INTEREST
Recorded Feb 26, 2021
From: ALTATHERA PHARMACEUTICALS LLC
To: SAGARD HEALTHCARE ROYALTY PARTNERS, LP
Reel/Frame 055427/0934 →
Continuity (2)
Continuation
16103815
· Aug 14, 2018
References Cited (376)
US 6043273A
· Duhaylongsod
· 2000
[cited by applicant]
US 6060454A
· Duhaylongsod
· 2000
[cited by applicant]
US 6101412A
· Duhaylongsod
· 2000
[cited by applicant]
US 6124363A
· Appleby et al.
· 2000
[cited by applicant]
US 6136327A
· Gupta et al.
· 2000
[cited by applicant]
US 6281246B2
· Sankaranarayanan
· 2001
[cited by applicant]
US 6369114B1
· Weil et al.
· 2002
[cited by applicant]
US 6482811B1
· Bacaner et al.
· 2002
[cited by applicant]
US 6491039B1
· Dobak, III
· 2002
[cited by applicant]
US 6500459B1
· Chhabra et al.
· 2002
[cited by applicant]
US 6544981B2
· Stein et al.
· 2003
[cited by applicant]
US 6627223B2
· Percel et al.
· 2003
[cited by applicant]
US 6632217B2
· Harper et al.
· 2003
[cited by applicant]
US 6645524B2
· Midha et al.
· 2003
[cited by applicant]
US 6720001B2
· Chen et al.
· 2004
[cited by applicant]
US 6800668B1
· Odidi et al.
· 2004
[cited by applicant]
US 6899700B2
· Gehling et al.
· 2005
[cited by applicant]
US 6916813B2
· Atwal et al.
· 2005
[cited by applicant]
US 7004171B2
· Benita et al.
· 2006
[cited by applicant]
US 7005425B2
· Belardinelli et al.
· 2006
[cited by applicant]
US 7005436B2
· Lloyd et al.
· 2006
[cited by applicant]
US 7022343B2
· Philbrook et al.
· 2006
[cited by applicant]
US 7048945B2
· Percel et al.
· 2006
[cited by applicant]
US 7090830B2
· Hale et al.
· 2006
[cited by applicant]
US 7179597B2
· Woosley
· 2007
[cited by applicant]
US 7289847B1
· Gill et al.
· 2007
[cited by applicant]
US 7341737B2
· Gehling et al.
· 2008
[cited by applicant]
US 7371254B2
· Dobak, III
· 2008
[cited by applicant]
US 7396524B2
· Yan
· 2008
[cited by applicant]
US 7417038B1
· Anker et al.
· 2008
[cited by applicant]
US 7526335B2
· Ferek-Petric
· 2009
[cited by applicant]
US 7538092B2
· Orlando et al.
· 2009
[cited by applicant]
US 7572776B2
· Yu et al.
· 2009
[cited by applicant]
US 7674820B2
· Fedida et al.
· 2010
[cited by applicant]
US 7745665B2
· Gant et al.
· 2010
[cited by applicant]
US 7765110B1
· Koneru
· 2010
[cited by applicant]
US 7776844B2
· Yu et al.
· 2010
[cited by applicant]
US 7815936B2
· Hasenzahl et al.
· 2010
[cited by applicant]
US 7829573B2
· Curwen et al.
· 2010
[cited by applicant]
US 7846968B2
· Chien et al.
· 2010
[cited by applicant]
US 7885824B1
· Koneru
· 2011
[cited by applicant]
US 7885827B1
· Koneru
· 2011
[cited by applicant]
US 7951183B2
· Dobak, III
· 2011
[cited by applicant]
US 8106099B2
· Brendel et al.
· 2012
[cited by applicant]
US 8236782B2
· Mosher et al.
· 2012
[cited by applicant]
US 8263125B2
· Vaya et al.
· 2012
[cited by applicant]
US 8268352B2
· Vaya et al.
· 2012
[cited by applicant]
US 8313757B2
· van Lengerich
· 2012
[cited by applicant]
US 8377994B2
· Gray et al.
· 2013
[cited by applicant]
US 8399018B2
· Lichter et al.
· 2013
[cited by applicant]
US 8440168B2
· Yang et al.
· 2013
[cited by applicant]
US 8465769B2
· Petereit et al.
· 2013
[cited by applicant]
US 8466277B2
· Orlando et al.
· 2013
[cited by applicant]
US 8575348B2
· Rao et al.
· 2013
[cited by applicant]
US 8696696B2
· Solem
· 2014
[cited by applicant]
US 8709076B1
· Matheny et al.
· 2014
[cited by applicant]
US 8753674B2
· Helson
· 2014
[cited by applicant]
US 8828432B2
· van Lengerich
· 2014
[cited by applicant]
US 8865213B2
· Sheth et al.
· 2014
[cited by applicant]
US 8871452B2
· Lee
· 2014
[cited by applicant]
US 8906847B2
· Cleemann et al.
· 2014
[cited by applicant]
US 8962574B2
· Reilly
· 2015
[cited by applicant]
US 8987262B2
· Leaute-Labreze et al.
· 2015
[cited by applicant]
US 9011526B2
· Matheny
· 2015
[cited by applicant]
US 9016221B2
· Brennan et al.
· 2015
[cited by applicant]
US 9044319B2
· Matheny
· 2015
[cited by applicant]
US 9060969B2
· Matheny
· 2015
[cited by applicant]
US 9078929B2
· Kuebelbeck et al.
· 2015
[cited by applicant]
US 9161952B2
· Matheny et al.
· 2015
[cited by applicant]
US 9239333B2
· Snider
· 2016
[cited by applicant]
US 9255104B2
· Rao et al.
· 2016
[cited by applicant]
US 9308084B2
· Matheny
· 2016
[cited by applicant]
US 9399067B2
· Mosher et al.
· 2016
[cited by applicant]
US 9474719B2
· Mullen et al.
· 2016
[cited by applicant]
US 9498481B2
· Rao et al.
· 2016
[cited by applicant]
US 9549912B2
· Milner et al.
· 2017
[cited by applicant]
US 9554989B2
· Kaplan et al.
· 2017
[cited by applicant]
US 9585851B2
· Yun et al.
· 2017
[cited by applicant]
US 9585884B2
· Rao et al.
· 2017
[cited by applicant]
US 9597302B1
· Yan et al.
· 2017
[cited by applicant]
US 9616026B2
· Singh
· 2017
[cited by applicant]
US 9682041B2
· Helson
· 2017
[cited by applicant]
US 9724297B2
· Thomas et al.
· 2017
[cited by applicant]
US 9770514B2
· Ghebre-Sellassie et al.
· 2017
[cited by applicant]
US 9889148B2
· Daemmgen et al.
· 2018
[cited by applicant]
US 9995756B2
· Saffitz et al.
· 2018
[cited by applicant]
US 20070009564A1
· McClain et al.
· 2007
[cited by applicant]
US 20070009654A1
· McClain et al.
· 2007
[cited by applicant]
US 20140235631A1
· Bunt et al.
· 2014
[cited by applicant]
US 20160082159A1
· Orlowski
· 2016
[cited by applicant]
US 20160128944A1
· Chawrai et al.
· 2016
[cited by applicant]
US 20160228379A1
· Kumar et al.
· 2016
[cited by applicant]
US 20160271157A1
· Ahmed et al.
· 2016
[cited by applicant]
US 20160303133A1
· Dudley et al.
· 2016
[cited by applicant]
US 20160317388A1
· Bhargava et al.
· 2016
[cited by applicant]
US 20170049705A1
· Mateescu et al.
· 2017
[cited by applicant]
US 20170087105A1
· Yan et al.
· 2017
[cited by applicant]
US 20170119627A1
· Bhargava et al.
· 2017
[cited by applicant]
US 20170157076A1
· Yacoby-Zeevi et al.
· 2017
[cited by applicant]
US 20170231885A1
· Cremers et al.
· 2017
[cited by applicant]
US 20170258781A1
· Noujaim et al.
· 2017
[cited by applicant]
US 20190380605A1
· Ivaturi et al.
· 2019
[cited by applicant]
US 20200226481A1
· Sim et al.
· 2020
[cited by applicant]
US 20200253903A1
· Somberg
· 2020
[cited by applicant]
US 20210283049A1
· Somberg
· 2021
[cited by applicant]
US 20220142954A1
· Somberg
· 2022
[cited by applicant]
US 20220339130A1
· Somberg et al.
· 2022
[cited by applicant]
US 20230075398A1
· Devlin et al.
· 2023
[cited by applicant]
US 20230187049A1
· Devlin et al.
· 2023
[cited by applicant]
US 20230225997A1
· Kashfian
· 2023
[cited by applicant]
US 20230248674A1
· Kashfian
· 2023
[cited by applicant]
US 20230255908A1
· Kashfian
· 2023
[cited by applicant]
US 20230255909A1
· Kashfian
· 2023
[cited by applicant]
US 20230270940A1
· Devlin et al.
· 2023
[cited by applicant]
US 20230285273A1
· Kashfian
· 2023
[cited by applicant]
US 20230293426A1
· Kashfian
· 2023
[cited by applicant]
US 20230310745A1
· Kashfian
· 2023
[cited by applicant]
US 20230372268A1
· Kashfian
· 2023
[cited by applicant]
US 20240156758A1
· Somberg
· 2024
[cited by applicant]
US 20240261242A1
· Kashfian
· 2024
[cited by applicant]
US 20250140361A1
· Kashfian et al.
· 2025
[cited by applicant]
US 20250152529A1
· Somberg et al.
· 2025
[cited by applicant]
US 20250152530A1
· Somberg et al.
· 2025
[cited by applicant]
US 20250213504A1
· Kashfian et al.
· 2025
[cited by applicant]
AU 737668B2
· 2001
[cited by applicant]
AU 765269B2
· 2003
[cited by applicant]
AU 2003233653A1
· 2003
[cited by applicant]
AU 2005299693A1
· 2006
[cited by applicant]
AU 2010231494A1
· 2011
[cited by applicant]
AU 2013203252A1
· 2013
[cited by applicant]
AU 2013381856A1
· 2015
[cited by applicant]
AU 2011289176B2
· 2015
[cited by applicant]
AU 2016266020B2
· 2018
[cited by applicant]
AU 2017357916A1
· 2019
[cited by applicant]
AU 2016313439B2
· 2019
[cited by applicant]
AU 2015269699B2
· 2020
[cited by applicant]
EP 0898964A1
· 1999
[cited by applicant]
EP 1027329B1
· 2003
[cited by applicant]
EP 1467705A2
· 2004
[cited by applicant]
EP 1474105A2
· 2004
[cited by applicant]
EP 1605976A1
· 2005
[cited by applicant]
EP 2429291A1
· 2012
[cited by applicant]
EP 1501467B1
· 2012
[cited by applicant]
EP 2238127B1
· 2012
[cited by applicant]
EP 2238128B1
· 2012
[cited by applicant]
EP 2228065B1
· 2012
[cited by applicant]
EP 2797556A1
· 2014
[cited by applicant]
EP 2861254A2
· 2015
[cited by applicant]
EP 3100728A1
· 2016
[cited by applicant]
EP 2999461A4
· 2017
[cited by applicant]
EP 2714011B1
· 2018
[cited by applicant]
EP 1951210B1
· 2018
[cited by applicant]
WO 9921829A1
· 1999
[cited by applicant]
WO 03020240A2
· 2003
[cited by applicant]
WO 03059318A2
· 2003
[cited by applicant]
WO 2004082716A1
· 2004
[cited by applicant]
WO 2007053393A2
· 2007
[cited by applicant]
WO 2010132711A1
· 2010
[cited by applicant]
WO 2012167212A3
· 2013
[cited by applicant]
WO 2013185764A2
· 2013
[cited by applicant]
WO 2014133539A1
· 2014
[cited by applicant]
WO 2014143108A1
· 2014
[cited by applicant]
WO 2014186843A1
· 2014
[cited by applicant]
Barbey, J.T., et al., “Pharmacokinetic, pharmacodynamic, and safety evaluation of an accelerated dose titration regimen of sotalol in healthy middle-aged subjects,”
[cited by applicant]
Ho, D.S.W., et al., “Rapid intravenous infusion of d-l sotalol: time to onset of effects on ventricular refractoriness, and safety,”
[cited by applicant]
Läer, S., et al., “Development of a safe and effective pediatric dosing regimen for sotalol based on population pharmacokinetics and pharmacodynamics in children with supraventricular tachycardia,”
[cited by applicant]
Lynch, J.J., et al., “Prevention of ventricular fibrillation by dextrorotatory sotalol in a conscious canine model of sudden coronary death,”
[cited by applicant]
Neumar, R. W., et al., “Part 8: Adult Advanced Cardiovascular Life Support,”
[cited by applicant]
Snider, M., et al., “Initial experience with antiarrhythmic medication monitoring by clinical pharmacists in an outpatient setting: a retrospective review,”
[cited by applicant]
Somberg, J.C., et al., “Developing a Safe Intravenous Sotalol Dosing Regimen,”
[cited by applicant]
Somberg, J.C., et al., “Gender Differences in Cardiac Repolarization Following Intravenous Sotalol Administration,”
[cited by applicant]
Yarlagadda, B., et al., “Safety and Efficacy of Inpatient Initiation of Dofetilide Versus Sotalol for Atrial Fibrillation,”
[cited by applicant]
El-Assaad, I., et al., “Lone Pediatric Atrial Fibrillation in the United States: Analysis of Over 1500 Cases,”
[cited by applicant]
Galloway, C.D., et al., “Development and Validation of a Deep-Learning Model to Screen for Hyperkalemia From the Electrocardiogram,”
[cited by applicant]
Hannun, A.Y., et al., “Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network,”
[cited by applicant]
Marill, K.A., et al, “Meta-analysis of the Risk of Torsades de Pointes in Patients Treated with Intravenous Racemic Sotalol,”
[cited by applicant]
Peters, F.P.J., et al., “Treatment of recent onset atrial fibrillation with intravenous solalol and/or flecainide,”
[cited by applicant]
Radford, D.J., et al., “Atrial Fibrillation in Children,”
[cited by applicant]
Thomas, S.P., et al., “Rapid loading of sotalol or amiodarone for management of recent onset symptomatic atrial fibrillation: A randomized, digoxin-controlled trial,”
[cited by applicant]
U.S. Appl. No. 16/376,706, filed Apr. 5, 2019, U.S. Patent and Trademark Office, Alexandria, VA [unpublished].
[cited by applicant]
Li et al., “Efficacy of Intravenous Sotalol for Treatment of Incessant Tacharrhythmias in Children,” Am J Cardiol 2017; 119: 1366-1370.
[cited by applicant]
Saul et al., “Pharmacokinetics and pharmacodynamics of sotalol in a pediatric population with superventricular and ventricular tacharrhythmia,” Clinical Pharmacology and Therapeutics, Mar. 2001.
[cited by applicant]
Batul et al., “Intravenous Sotalol- Reintroducing a Forgotten Agent to the Electrophysiology Therapeutic Arsenal,” Journal of Atrial Firbillation, Feb.-Mar. 2017, vol. 9, Issue 5.
[cited by applicant]
(Ivaturi, Vijay et al.) U.S. Appl. No. 16/376,706, filed Apr. 5, 2019, Specification, Claims, Figures.
[cited by applicant]
(Ivaturi, Vijay et al.) U.S. Appl. No. 16/549,620, filed Aug. 23, 2019, Specification, Claims, Figures and File History as of Dec. 2020, 77 pages (abandoned).
[cited by applicant]
(Ivaturi, Vijay et al.) U.S. Appl. No. 17/003,297, filed Aug. 26, 2020, Specification, Claims, Figures.
[cited by applicant]
(Somberg, John C. et al.) Co-Pending U.S. Appl. No. 16/103,815, filed Aug. 14, 2018, Specification, Claims, Figures.
[cited by applicant]
(Somberg, John C. et al.) Co-Pending U.S. Appl. No. 16/693,310, filed Nov. 24, 2019, Specification, Claims, Figures.
[cited by applicant]
(Somberg, John C. et al.) Co-Pending U.S. Appl. No. 16/726,361, filed Dec. 24, 2019, Specification, Claims, Figures.
[cited by applicant]
(Somberg, John) Co-Pending U.S. Appl. No. 16/849,099, filed Apr. 15, 2020, Specification and Claims.
[cited by applicant]
(Somberg, John) Co-Pending U.S. Appl. No. 16/863,567, filed Apr. 30, 2020, Specification and Claims.
[cited by applicant]
(Somberg, John) Co-Pending U.S. Appl. No. 16/946,941, filed Jul. 13, 2020, Specification and Claims.
[cited by applicant]
Campbell, T.J., “Intravenous sotalol for the treatment of atrial fibrillation and flutter after cardiopulmonary bipass comparison with disopyramide and digoxin in a randomised trial,” BR Heart J. (1985) 54:86-90.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/103,815, Final Office Action dated Aug. 13, 2019, 13 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/103,815, Non-Final Office Action dated Feb. 6, 2019, 9 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/103,815, Notice of Allowance dated Oct. 30, 2019, 12 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/103,815, Response to Aug. 13, 2019 Final Office Action, filed Oct. 17, 2019, 10 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/103,815, Response to Dec. 13, 2018 Restriction Requirement, filed Dec. 31, 2018, 3 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/103,815, Response to Feb. 6, 2019 Non-Final Office Action, filed May 6, 2019, 17 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/103,815, Restriction Requirement dated Dec. 13, 2018, 6 pages.
[cited by applicant]
Co-pending U.S. Appl. No. 16/376,706, Final Office Action dated Mar. 27, 2020, 12 pages.
[cited by applicant]
Co-pending U.S. Appl. No. 16/376,706, Non-final Office Action dated Nov. 12, 2019, 12 pages.
[cited by applicant]
Co-pending U.S. Appl. No. 16/376,706, Notice of Allowance and Examiner Initiated Interview Summary dated Jun. 10, 2020, 8 pages.
[cited by applicant]
Co-pending U.S. Appl. No. 16/376,706, Response to Mar. 27, 2020 Final Office Action dated May 27, 2020, 11 pages.
[cited by applicant]
Co-pending U.S. Appl. No. 16/376,706, Response to Nov. 12, 2019 Non-Final Office Action filed Feb. 12, 2020, 10 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/693,310, Non-Final Office Action dated Feb. 7, 2020, 12 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/693,310, Response to Feb. 7, 2020 Non-Final Office Action, filed May 5, 2020, 20 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/849,099, Final Office Action dated Feb. 3, 2021, 24 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/849,099, Non-Final Office Action dated Jul. 9, 2020, 19 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/849,099, Response to July 9, 2020Non-Final Office Action, dated Dec. 9, 2020, 10 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/863,567, Final Office Action dated Dec. 28, 2020, 17 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/863,567, Non-Final Office Action dated Jun. 4, 2020, 18 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/863,567, Response to Jun. 4, 2020 Non-Final Office Action dated Dec. 4, 2020, 10 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/863,567, Response to May 13, 2020 Restriction Requirement, filed May 26, 2020, 44 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/863,567, Restriction Requirement dated May 13, 2020, 5 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/946,941, Preliminary Amendment filed Jan. 20, 2021, 3 pages.
[cited by applicant]
Dahmane, E., “Clinical Pharmacology-Driven Research to Optimize Bedside Therapeutics of Sotalol Therapy,” Clin Transl Sci (2019) 12:648-656.
[cited by applicant]
FDA Highlights of Prescribing Information sotalol hydrochloride injection (2009), https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022306s000lbl.pdf.
[cited by applicant]
FDA Highlights of Prescribing Information Sotylize (sotalol hydrochloride (2014), https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205108s000lbl.pdf.
[cited by applicant]
Gomes, J.A., “Oral d,l Sotalol reduces the incidence of postoperative atrial fibrillation in coronary artery bypass surgery patients: a randomized, double-blind, placebo-controlled study,” J. Am. Coll. Cardio. 34(2):334…
[cited by applicant]
Kerin, Nicholas A., “Intravenous Sotalol: an under used treatment strategy,” Cardiology (2018) 140:143-145.
[cited by applicant]
Li, X., “Pediatric dosing of intravenous sotalol based on body surface area in patients with arrhythmia,” Pediatr Cardiol (2017) 38:1450-1455.
[cited by applicant]
Patel, A., “Is Sotalol more effective than standard beta-blockers for prophylaxis of atrial fibrillation during cardiac surgery?” Interactive CardioVascular and Thoracic Surgery 4 (2005) 147-50.
[cited by applicant]
Peters, N.S., “Post-cardioversion atrial fibrillation: the synthesis of modern concepts?” european Heart J. (2000) 21, 1119-1121.
[cited by applicant]
Sanjuan, R., “Preoperative use of sotalol versus atenolol for atrial fibrillation after cardiac surgery,” Ann Thorac Surg (2004) 77:838-43.
[cited by applicant]
Somberg, J.C., “QT prolongation and serum sotalol concentration are highly correlated following intravenous and oral sotalol,” Cardiology (2010) 116(3):219-25.
[cited by applicant]
Tse, H.F., “Atrial pacing for suppression of early reinitiation of atrial fibrillation after successful internal cardioversion,” european Heart J. (2000) 21, 1167-1176.
[cited by applicant]
U.S. Appl. No. 16/376,706 (U.S. Pat. No. 10,799,138), file history Dec. 2020, 151 pages.
[cited by applicant]
Valdes, S.O., “early experience with intravenous sotalol in children with and without congenital heart disease,” Heart Rhythm 15(12): 1862-1869, Elsevier Inc., (Jul. 9, 2018).
[cited by applicant]
(Somberg, John) Co-Pending U.S. Appl. No. 17/306,490, filed May 3, 2021, Specification and Claims.
[cited by applicant]
U.S. Appl. No. 17/003,297, Preliminary Amendment filed Dec. 8, 2020, 9 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/693,310, Final Office Action dated Sep. 3, 2021, 20 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/693,310, Petition Decision dated Mar. 29, 2021, 2 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/863,567, Non-Final Office Action and Examiner Initiated Interview Summary dated Jun. 9, 2021, 14 pages.
[cited by applicant]
Hoffman et al. “Renal Insufficiency and Medication in Nursing Homes” Medicine Deutsches Arzteblatt International 2016; 113: 92-98.
[cited by applicant]
(Devlin, Jodi) Co-pending U.S. Appl. No. 17/566,840, filed Dec. 31, 2021, Specification, Claims, and Figures.
[cited by applicant]
(Somberg, John) Co-Pending U.S. Appl. No. 17/585,190, filed Jan. 26, 2022, Specification and Claims.
[cited by applicant]
(Somberg, John) Co-Pending U.S. Appl. No. 17/725,189, filed Apr. 20, 2022, Specification and Claims.
[cited by applicant]
U.S. Appl. No. 17/003,297, Non-Final Office Action dated Mar. 14, 2022, 14 pages.
[cited by applicant]
U.S. Appl. No. 17/003,297, Response to Mar. 14, 2022 Non-Final Office Action, dated Jun. 15, 2022, 12 pages.
[cited by applicant]
Batra, Anjan S., et al., “Junctional ectopic tachycardia: Current strategies for diagnosis and management,” Progress in Pediatric Cardiology, 35 (2013) 49-54.
[cited by applicant]
Blair, Andrew D., et al., Sotalol kinetics in renal insufficiency, Clin. Pharmacol. Ther., 457-463 (Apr. 1981) (7 pages).
[cited by applicant]
Borquez, Alejandro A., et al., “Intravenous Sotalol in the Young, Safe and Effective Treatment With Standardized Protocols,” JACC: Clinical Elecrophysiology, vol. 6, No. 4, Apr. 2020:425-32 (2020).
[cited by applicant]
CHOC Children's, “Junctional Ectopic Tachycardia (JET) Care Guideline for Cardiovascular Intensive Care Unit (CVICU),” Sep. 18, 2019.
[cited by applicant]
Cilliers, Antionette M., et al., “Junctional ectopic tachycardia in six paediatric patients,” Heart; 78:413-415 (1997).
[cited by applicant]
Co-Pending U.S. Appl. No. 16/693,310, Response to Sep. 3, 2021 Final Office Action, dated Feb. 3, 2022, 7 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/849,099, Notice of Abandonment, Aug. 20, 2021, 2 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/863,567, Advisory Action dated Dec. 30, 2021, 11 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/863,567, Final Office Action dated Oct. 26, 2021, 11 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/863,567, Response to Jun. 9, 2021 Non-Final Office Action dated Oct. 12, 2021, 8 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/863,567, Response to Oct. 26, 2021 Final Office Action, dated Dec. 10, 2021, 8 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/946,941, Non-Final Office Action dated Feb. 7, 2022, 15 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/946,941, Notice of Allowance dated Apr. 4, 2022, 9 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/946,941, Response to Feb. 7, 2022 Non-Final Office Action, dated Mar. 8, 2022, 6 pages.
[cited by applicant]
Co-pending U.S. Appl. No. 17/566,840, Non-Final Office Action dated Mar. 23, 2022, 11 pages.
[cited by applicant]
Co-pending U.S. Appl. No. 17/566,840, Petition Under 37 CFR 1.181 and Preliminary Amendment, dated Feb. 22, 2022, 9 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/585,190, Preliminary Amendment dated Mar. 4, 2022, 4 pages.
[cited by applicant]
Dumas, M. et al., “Variations of sotalol kinetics in renal insufficiency”, International Journal of Clinical Pharmacology, Therapy, and Toxicology, Oct. 1, 1989, 27(10), Abstract only.
[cited by applicant]
Learn the Heart, “Antiarrhythmic Drug Review,” https://www.healio.com/cardiology/learn-the-heart/cardiology-review/topic-reviews/antiarrhythmic-drugs (Year: 2022).
[cited by applicant]
Maragnes, P., et al., “Usefulness of oral sotalol for the treatment of junctional ectopic tachycardia,” Int'l J. of Cardiology, 35 (1995) 165-167.
[cited by applicant]
Sundquist, H.K. et al., “Serum levels and half-life of sotalol in chronic renal failure”, Annals of Clinical Research, Dec. 1, 1975, 7(6), Abstract Only.
[cited by applicant]
(Devlin, Jodi) Co-pending U.S. Appl. No. 18/107,785, filed Feb. 9, 2023, Specification, Claims, and Figures.
[cited by applicant]
(Devlin, Jodi) Co-pending U.S. Appl. No. 18/121,980, filed Mar. 15, 2023, Specification, Claims, and Figures.
[cited by applicant]
(Ivaturi, Vijay et al.) U.S. Appl. No. 18/156,092, filed Jan. 18, 2023, Specification, Claims, Figures.
[cited by applicant]
(Kashfian, Brandon Ira et al.) Co-Pending U.S. Appl. No. 17/892,301, filed Aug. 22, 2022, Specification and Claims.
[cited by applicant]
(Kashfian, Brandon Ira) Co-Pending U.S. Appl. No. 18/126,561, filed Mar. 27, 2023, Specification and Claims.
[cited by applicant]
(Somberg, John C. et al.) Co-Pending U.S. Appl. No. 17/861,226, filed Jul. 10, 2022, Specification, Claims, Figures.
[cited by applicant]
U.S. Appl. No. 17/003,297, Final Office Action dated Jul. 27, 2022, 16 pages.
[cited by applicant]
U.S. Appl. No. 17/003,297, Notice of Allowance dated Oct. 18, 2022, 7 pages.
[cited by applicant]
U.S. Appl. No. 17/003,297, Response to Final Office Action dated Sep. 27, 2022, 12 pages.
[cited by applicant]
Boriani, G. et al., Increase in QT/QTc dispersion after low energy cardioversion of chronic persistent atrial fibrillation. International Journal of Cardiology. 2004; 95, 245-250.
[cited by applicant]
Cantillon, D. J. and Amuthan, R. “Atrial Fibrillation”, Cleveland Clinic: Center for Continuing Education, Disease Management: https://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/cardiology/atrial-fibrill…
[cited by applicant]
Co-Pending U.S. Appl. No. 16/693,310, Non-Final Office Action dated Jul. 21, 2022, 16 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/693,310, Notice of Allowance dated Mar. 9, 2023, 7 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 16/693,310, Response to Jul. 21, 2022 Non-Final Office Action including Rule 132 Affidavit, dated Jan. 20, 2023, 15 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/306,490, Preliminary Amendment filed Dec. 7, 2022, 38 pages.
[cited by applicant]
Co-pending U.S. Appl. No. 17/566,840, Notice of Allowance dated Jul. 25, 2022, 7 pages.
[cited by applicant]
Co-pending U.S. Appl. No. 17/566,840, Notice of Allowance dated Nov. 9, 2022, 7 pages.
[cited by applicant]
Co-pending U.S. Appl. No. 17/566,840, Response to Mar. 23, 2022 Non-Final Office Action, dated Jul. 7, 2022, 10 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/861,226, Preliminary Amendment dated Jul. 10, 2022, 4 pages.
[cited by applicant]
FDA “Highlights of Prescribing Information” for sotalol hydrochloride injection, Revised Mar. 2020, 16 pages, https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022306s005lblrpl.pdf.
[cited by applicant]
Le Coz, F. et al. Pharmacokinetic and pharmacodynamic modeling of the effects of oral and intravenous administrations of dofetilide on ventricular repolarization. Clin Pharmacol Ther 1995; 57:533.
[cited by applicant]
Procainamide Dosage. Drugs.com. Last updated Sep. 13, 2021. 3 pages.
[cited by applicant]
Rasmussen, H.S. et al., Dofetilide, A Novel Class III Antiarrhythmic Agent, J Cardiovasc Pharmacol. 1992;20 Suppl 2:S96-105.
[cited by applicant]
Rosseau, M. F., Cardiac and Hemodynamic Effects of Intravenous Dofetilide in Patients With Heart Failure, Am J Cardiol 2001;87:1250-1254.
[cited by applicant]
Sedgwick, M. et al., Pharmacokinetic and pharmacodynamic effects of UK-68,798, a new potential class III antiarrhythmic drug, Br. J. Clin. Pharmac. (1991), 31, 515-519.
[cited by applicant]
Somberg, et al., “Sotalol versus Amiodarone in Treatment of Atrial Fibrillation,” J. Atrial Fibrillation, Feb.-Mar. 2016, vol., Issue 5.
[cited by applicant]
(Kashfian, Brandon Ira) Co-Pending U.S. Appl. No. 18/135,467, filed Apr. 17, 2023, Specification and Claims.
[cited by applicant]
(Kashfian, Brandon Ira) Co-Pending U.S. Appl. No. 18/304,196, filed Apr. 20, 2023, Specification and Claims.
[cited by applicant]
(Kashfian, Brandon Ira) Co-Pending U.S. Appl. No. 18/306,660, filed Apr. 25, 2023, Specification and Claims.
[cited by applicant]
(Kashfian, Brandon Ira) Co-Pending U.S. Appl. No. 18/315,790, filed May 11, 2023, Specification and Claims.
[cited by applicant]
(Kashfian, Brandon Ira) Co-Pending U.S. Appl. No. 18/321,220, filed May 22, 2023, Specification and Claims.
[cited by applicant]
(Kashfian, Brandon Ira) Co-Pending U.S. Appl. No. 18/323,337, filed May 24, 2023, Specification and Claims.
[cited by applicant]
(Kashfian, Brandon Ira) Co-Pending U.S. Appl. No. 18/324,703, filed May 26, 2023, Specification and Claims.
[cited by applicant]
(Somberg, John C. et al.) Co-Pending U.S. Appl. No. 18/322,111, filed May 23, 2023, Specification, Claims, Figures.
[cited by applicant]
(Somberg, John) Co-Pending U.S. Appl. No. 18/417,748, filed Jan. 19, 2024, Specification and Claims.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/585,190, Restriction Requirement dated Oct. 19, 2023, 5 pages.
[cited by applicant]
Co-pending U.S. Appl. No. 18/121,980, Preliminary Amendment dated Jul. 18, 2023, 6 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 18/322,111, Preliminary amendment dated Jan. 31, 2024, 7 pages.
[cited by applicant]
Falk, Rodney H. et al, Intravenous Dofetilide, a Class III Antiarrhythmic Agent, for the Termination of Sustained Atrial Fibrillation or Flutter, JACC vol. 29, No. 2, 385-90 (Feb. 1997).
[cited by applicant]
Von Bergen, N. H. et al. “Outpatient intravenous sotalol load to replace 3-day admission oral sotalol load”, Heart Rhythm Case Reports (Jul. 2019), vol. 5, issue 7, p. 382-383.
[cited by applicant]
(Kashfian, Brandon Ira) Co-Pending U.S. Appl. No. 18/631,538, filed Apr. 10, 2024, Specification and Claims.
[cited by applicant]
U.S. Appl. No. 18/156,092, Response to Notice to File Missing Parts and Preliminary Amendment, dated Apr. 4, 2023, 6 pages.
[cited by applicant]
Co-pending U.S. Appl. No. 18/107,785, Preliminary Amendment dated Feb. 15, 2024, 10 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 18/417,748, Preliminary Amendment dated Apr. 22, 2024, 6 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/306,490, Non-Final Office Action dated Jun. 7, 2024, 50 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/306,490, Response to Jun. 7, 2024 Non-Final Office Action, dated Dec. 6, 2024, 9 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/725,189, Non-Final Office Action dated Jun. 18, 2024, 10 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/725,189, Response to Jun. 18, 2024 Non-Final Office Action, dated Dec. 18, 2024, 5 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/861,226, Non-Final Office Action dated Jul. 16, 2024, 17 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/861,226, Response to Jul. 16, 2024 Non-Final Office Action, dated Dec. 16, 2024, 9 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/892,301, Restriction Requirement dated Dec. 3, 2024, 6 pages.
[cited by applicant]
Somberg, John et al. Model-Informed Development of Sotalol Loading and Dose Escalation Employing an Intravenous Infusion. Cardiol Res. 2020;11(5):294-304.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/306,490, Response to Mar. 11, 2025 Final Office Action, dated Jun. 26, 2025, 6 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/725,189, Notice of Allowance dated Apr. 30, 2025, 9 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/861,226, Response to Mar. 21, 2025 Final Office Action, dated Jun. 23, 2025, 11 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/892,301, Notice of Allowance dated Jul. 11, 2025, 8 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/892,301, Response to Mar. 24, 2025 Non-Final Office Action, dated Jun. 24, 2025, 9 pages.
[cited by applicant]
Co-pending U.S. Appl. No. 18/107,785, Non-Final Office Action dated May 8, 2025, 9 pages.
[cited by applicant]
(Kashfian, Brandon Ira et al.) Co-Pending U.S. Appl. No. 19/009,774, filed Jan. 3, 2025, Specification, Drawings, and Claims.
[cited by applicant]
(Kashfian, Brandon Ira et al.) Co-Pending U.S. Appl. No. 19/080,585, filed Mar. 14, 2025, Specification and Claims.
[cited by applicant]
(Somberg, John et al.) Co-Pending U.S. Appl. No. 19/019,556, filed Jan. 14, 2025, Specification and Claims.
[cited by applicant]
(Somberg, John et al.) Co-Pending U.S. Appl. No. 19/022,878, filed Jan. 15, 2025, Specification and Claims.
[cited by applicant]
Bianconi, L. et al., Comparison of intravenously administered dofetilide versus amiodarone in the acute termination of atrial fibrillation and flutter, European Heart Journal (2000) 21, 1265-1273, 9 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/306,490, Final Office Action dated Mar. 11, 2025, 13 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/861,226, Final Office Action dated Mar. 21, 2025, 24 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/861,226, Interview Summary dated Jan. 7, 2025, 2 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/892,301, Response to Dec. 3, 2024 Restriction Requirement, dated Mar. 3, 2025, 7 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 17/892,301, Non-Final Office Action dated Mar. 24, 2025, 11 pages.
[cited by applicant]
Co-Pending U.S. Appl. No. 19/019,556, Preliminary Amendment dated Jan. 14, 2025, 4 pages.
[cited by applicant]
Dailymed Website, Tikosyn (dofetilide) Capsules, https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=02438044-d6a3-49e9-a1ac-3aad21ef2c8c (Year: 1999), 21 pages.
[cited by applicant]
Kerin, N. Z. and Jacob, S., The Efficacy of Sotalol in Preventing Postoperative Atrial Fibrillation: A Meta-Analysis, The American Journal of Medicine, vol. 124, No. 9, Sep. 2011, 9 pages.
[cited by applicant]
Cited By (1)