Last Updated: June 25, 2026

SOTALOL Drug Patent Profile

Name: SOTALOL Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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Which patents cover Sotalol, and when can generic versions of Sotalol launch?

Sotalol is a drug marketed by Altathera Pharms Llc, Apotex, Aurobindo Pharma Usa, Epic Pharma Llc, Impax Pharms, Novitium Pharma, Oxford Pharms, Regcon Holdings, Rising, Sun Pharm Industries, Teva, Upsher Smith Labs, and Watson Labs. and is included in seventeen NDAs. There are seven patents protecting this drug.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sotalol

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

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Summary for SOTALOL

US Patents:	0
Applicants:	13
NDAs:	17
Drug Prices:	Drug price information for SOTALOL
DailyMed Link:	SOTALOL at DailyMed

Drug patent expirations by year for SOTALOL

US Patents and Regulatory Information for SOTALOL

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	075725-001	Dec 19, 2000		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Oxford Pharms	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	075563-002	Nov 7, 2003	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sun Pharm Industries	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	075515-002	Oct 15, 2001		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Upsher Smith Labs	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	TABLET;ORAL	075366-002	May 1, 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

DrugChatter Q&A for SOTALOL

Sotalol generic excipients?
Sotalol impurity manufacturers in uk?
How much does sotalol cost?
How much does sotalol cost?
Sotalol impurity manufacturers in usa?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.