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Last Updated: August 13, 2020

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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, Arbor Pharms Llc, Covis Pharma Bv, Upsher Smith Labs, Apotex, 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 three 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 ten drug master file entries for sotalol hydrochloride. Seventeen 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
Vanderbilt University Medical CenterPhase 3
Shengjing HospitalPhase 4
Wojciech ZarebaPhase 2

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

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 075563-004 Nov 7, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Pharms SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075663-003 Nov 7, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075237-004 May 1, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 076140-001 Sep 26, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075237-003 May 1, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Teva SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 076883-003 Jul 26, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

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