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Last Updated: December 4, 2022

Sotalol hydrochloride - Generic Drug Details


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What are the generic sources for sotalol hydrochloride and what is the scope of patent protection?

Sotalol hydrochloride is the generic ingredient in five branded drugs marketed by Altathera Pharms Llc, Azurity, Covis, Upsher Smith Labs, Apotex, Aurobindo Pharma Usa, Beximco Pharms Usa, Epic Pharma Inc, Impax Pharms, Mylan, Oxford Pharms, Sun Pharm Industries, Teva, and Watson Labs, and is included in twenty-one NDAs. There are five 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 suppliers are listed for this compound.

Recent Clinical Trials for sotalol hydrochloride

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

SponsorPhase
Abant Izzet Baysal UniversityN/A
SanofiPhase 4
Duke Clinical Research InstitutePhase 4

See all sotalol hydrochloride clinical trials

Pharmacology for sotalol hydrochloride
Drug Class Antiarrhythmic
Mechanism of ActionAdrenergic beta-Antagonists
Physiological Effect Cardiac Rhythm Alteration
Medical Subject Heading (MeSH) Categories 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
Oxford Pharms SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075563-001 Nov 7, 2003 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 076214-002 Aug 27, 2003 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Beximco Pharms Usa SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 207428-002 Oct 21, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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