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Last Updated: November 21, 2024

SOTALOL HYDROCHLORIDE Drug Patent Profile


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Which patents cover Sotalol Hydrochloride, and when can generic versions of Sotalol Hydrochloride launch?

Sotalol Hydrochloride is a drug marketed by Altathera Pharms Llc, Apotex, Aurobindo Pharma Usa, Beximco Pharms Usa, Epic Pharma Llc, Impax Pharms, Natco Pharma Usa, Oxford Pharms, Rising, Sun Pharm Industries, Teva, Upsher Smith Labs, and Watson Labs. and is included in seventeen NDAs. There are four patents protecting this drug.

The generic ingredient in SOTALOL HYDROCHLORIDE is sotalol hydrochloride. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sotalol Hydrochloride

A generic version of SOTALOL HYDROCHLORIDE was approved as sotalol hydrochloride by TEVA on May 1st, 2000.

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Drug patent expirations by year for SOTALOL HYDROCHLORIDE
Recent Clinical Trials for SOTALOL HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Rush University Medical CenterN/A
HagaZiekenhuisPhase 2/Phase 3
Abant Izzet Baysal UniversityN/A

See all SOTALOL HYDROCHLORIDE clinical trials

Pharmacology for SOTALOL HYDROCHLORIDE
Drug ClassAntiarrhythmic
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration
Medical Subject Heading (MeSH) Categories for SOTALOL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for SOTALOL HYDROCHLORIDE

US Patents and Regulatory Information for SOTALOL HYDROCHLORIDE

SOTALOL HYDROCHLORIDE is protected by six US patents.

Patents protecting SOTALOL HYDROCHLORIDE

Method of initiating and escalating sotalol hydrochloride dosing
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION.

Method of initiating and escalating sotalol hydrochloride dosing
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: INTRAVENOUS SOTALOL DOSING REGIMEN FOR ACHIEVING STEADY STATE EXPOSURE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING

Method of administering sotalol IV/switch
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: INTRAVENOUS SOTALOL DOSING REGIMEN FOR USE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING

Method of administering sotalol IV/switch
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE FOR LOADING DOSE IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM OR FOR THE TREATMENT OF LIFE-THREATENING VENTRICULAR TACHYCARDIA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: INTRAVENOUS SOTALOL DOSING REGIMEN FOR USE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rising SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075725-004 Dec 19, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Natco Pharma Usa SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075237-003 May 1, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075429-001 May 1, 2000 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075238-001 Jul 13, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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