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Last Updated: November 4, 2024

SOTALOL HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for sotalol hydrochloride and what is the scope of freedom to operate?

Sotalol hydrochloride is the generic ingredient in five branded drugs marketed by Altathera Pharms Llc, Azurity, Legacy Pharma, Aiping Pharm Inc, 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 twenty-one NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sotalol hydrochloride has one patent family member in one country.

There are seven drug master file entries for sotalol hydrochloride. Twenty-three suppliers are listed for this compound.

Summary 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Usa SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 077616-003 Feb 7, 2007 AB RX 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
Oxford Pharms SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075563-004 Nov 7, 2003 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
Impax Pharms SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075663-002 Nov 7, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aiping Pharm Inc SORINE sotalol hydrochloride TABLET;ORAL 075500-001 Apr 27, 2001 AB RX 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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