Last Updated: November 5, 2026

LABETALOL Drug Patent Profile

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

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

Labetalol is a drug marketed by Amneal, Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Onesource Specialty, Rising, Aiping Pharm Inc, Appco, Cadila Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Hibrow Hlthcare, Innogenix, Macleods Pharms Ltd, Ph Health, Rubicon Research, Teva, Unichem, Watson Labs, and Zydus Pharms. and is included in twenty-eight NDAs.

The generic ingredient in LABETALOL is labetalol hydrochloride. There is one drug master file entry for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Labetalol

A generic version of LABETALOL was approved as labetalol hydrochloride by HERITAGE PHARMA on August 3^rd, 1998.

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Summary for LABETALOL

US Patents:	0
Applicants:	23
NDAs:	28
Drug Prices:	Drug price information for LABETALOL
Drug Sales Revenues:	Drug sales revenues for LABETALOL
DailyMed Link:	LABETALOL at DailyMed

Drug patent expirations by year for LABETALOL

US Patents and Regulatory Information for LABETALOL

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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
Macleods Pharms Ltd	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	217949-001	Sep 23, 2025	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Heritage Pharma	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	074787-002	Aug 3, 1998	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Rubicon Research	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	211953-003	Aug 18, 2021	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Zydus Pharms	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	207743-002	Sep 19, 2017	AB	RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Ph Health	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	200908-002	Jul 10, 2012		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 LABETALOL

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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.