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Last Updated: November 26, 2020

DrugPatentWatch Database Preview

SOTALOL HYDROCHLORIDE Drug 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, Beximco Pharms Usa, Epic Pharma Inc, Impax Pharms, Mylan, Oxford Pharms, Sun Pharm Industries, Teva, Upsher Smith Labs, and Watson Labs. and is included in seventeen NDAs. There is one patent protecting this drug.

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

US ANDA 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
Kansas City Heart Rhythm Research FoundationPhase 4
Vanderbilt University Medical CenterPhase 3
Shengjing HospitalPhase 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 075515-002 Oct 15, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075725-004 Dec 19, 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
Teva SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 076883-001 Jul 26, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Teva SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075429-004 May 1, 2000 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075238-001 Jul 13, 2000 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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