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Last Updated: March 6, 2021

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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 patent protection?

Sotalol hydrochloride is the generic ingredient in five branded drugs marketed by Altathera Pharms Llc, Arbor Pharms Llc, Covis, 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. Nineteen suppliers are listed for this compound.

Summary for sotalol hydrochloride
International Patents:1
US Patents:3
Drug Master File Entries: 10
Suppliers / Packagers: 19
Bulk Api Vendors: 93
Clinical Trials: 37
Patent Applications: 1,450
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in sotalol hydrochloride?sotalol hydrochloride excipients list
DailyMed Link:sotalol hydrochloride at DailyMed
Recent Clinical Trials for sotalol hydrochloride

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

National Institute on Aging (NIA)Phase 4
Weill Medical College of Cornell UniversityPhase 4
Kansas City Heart Rhythm Research FoundationPhase 4

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
Sun Pharm Industries SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 076576-003 Apr 8, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 076140-004 Sep 26, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Oxford Pharms SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075563-004 Nov 7, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Teva SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075429-001 May 1, 2000 AB RX 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:

Harvard Business School
Express Scripts
Boehringer Ingelheim

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