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Last Updated: November 4, 2024

BETAPACE Drug Patent Profile


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When do Betapace patents expire, and what generic alternatives are available?

Betapace is a drug marketed by Legacy Pharma and is included in two NDAs.

The generic ingredient in BETAPACE is sotalol hydrochloride. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Betapace

A generic version of BETAPACE was approved as sotalol hydrochloride by TEVA on May 1st, 2000.

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Summary for BETAPACE
Drug patent expirations by year for BETAPACE
Drug Prices for BETAPACE

See drug prices for BETAPACE

Drug Sales Revenue Trends for BETAPACE

See drug sales revenues for BETAPACE

Recent Clinical Trials for BETAPACE

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

SponsorPhase
Medtronic (Shanghai) Management Co. Ltd.Phase 4
Beijing CTSmed Co. LtdPhase 4
Xinhua Hospital, Shanghai Jiao Tong University School of MedicinePhase 4

See all BETAPACE clinical trials

Pharmacology for BETAPACE
Drug ClassAntiarrhythmic
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration

US Patents and Regulatory Information for BETAPACE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Legacy Pharma BETAPACE sotalol hydrochloride TABLET;ORAL 019865-001 Oct 30, 1992 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Legacy Pharma BETAPACE AF sotalol hydrochloride TABLET;ORAL 021151-007 Apr 2, 2003 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Legacy Pharma BETAPACE sotalol hydrochloride TABLET;ORAL 019865-003 Oct 30, 1992 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Legacy Pharma BETAPACE AF sotalol hydrochloride TABLET;ORAL 021151-001 Feb 22, 2000 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Legacy Pharma BETAPACE sotalol hydrochloride TABLET;ORAL 019865-005 Apr 20, 1994 AB RX Yes 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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