LABETALOL Drug Patent Profile

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, Andas 5 Holding, Appco, Cadila Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Hibrow Hlthcare, 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 are fourteen drug master file entries for this compound. Forty-one 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.

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

See drug prices for LABETALOL

See drug sales revenues for LABETALOL

US Patents and Regulatory Information for LABETALOL

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
Epic Pharma Llc	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	212990-002	Sep 30, 2020	AB	RX	No	No
Rubicon Research	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	211953-003	Aug 18, 2021	AB	RX	No	No
Zydus Pharms	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	207743-002	Sep 19, 2017	AB	RX	No	No
Ph Health	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	200908-002	Jul 10, 2012	AB	RX	No	Yes
Teva	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	074989-001	Sep 30, 1998		DISCN	No	No

DrugChatter Q&A for LABETALOL

Labetalol hydrochloride exporter?
Labetalol patent date 1966?
Labetalol hcl 100 mg tablet?
Labetalol fda approval date 1984?
Labetalol generic and brand name?