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Last Updated: December 5, 2023

Labetalol hydrochloride - Generic Drug Details

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What are the generic sources for labetalol hydrochloride and what is the scope of freedom to operate?

Labetalol hydrochloride is the generic ingredient in five branded drugs marketed by Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience, Schering, Sebela Ireland Ltd, Appco, Cadila Pharms Ltd, Epic Pharma Llc, Eywa, Heritage Pharma, Innogenix, Par Form, Rubicon, Sandoz, Teva, Unichem, Watson Labs, Zydus Pharms, and Alvogen, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for labetalol hydrochloride. Forty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for labetalol hydrochloride

US Patents:	0
Tradenames:	5
Applicants:	24
NDAs:	30
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	67
Patent Applications:	1,182
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in labetalol hydrochloride?	labetalol hydrochloride excipients list
DailyMed Link:	labetalol hydrochloride at DailyMed

Recent Clinical Trials for labetalol hydrochloride

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

Sponsor	Phase
Loma Linda University	N/A
Zagazig University	Phase 2
Nebraska Methodist Health System	Phase 4

See all labetalol hydrochloride clinical trials

Generic filers with tentative approvals for LABETALOL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	5MG/ML	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for labetalol hydrochloride

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for labetalol hydrochloride

Adrenergic alpha-1 Receptor Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Sympathomimetics

US Patents and Regulatory Information for labetalol hydrochloride

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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
Watson Labs	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	075133-001	Aug 3, 1998	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Heritage Pharma	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	074787-002	Aug 3, 1998	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Par Form	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	200908-003	Jul 10, 2012	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	075113-002	Aug 4, 1998	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	INJECTABLE;INJECTION	075524-001	Nov 29, 1999		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Appco	LABETALOL HYDROCHLORIDE	labetalol hydrochloride	TABLET;ORAL	209603-002	Jun 20, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for labetalol hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-003	Aug 1, 1984	⤷ Try a Trial	⤷ Try a Trial
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-001	May 24, 1985	⤷ Try a Trial	⤷ Try a Trial
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984	⤷ Try a Trial	⤷ Try a Trial
Sebela Ireland Ltd	TRANDATE	labetalol hydrochloride	INJECTABLE;INJECTION	019425-001	Dec 31, 1985	⤷ Try a Trial	⤷ Try a Trial
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-002	Aug 1, 1984	⤷ Try a Trial	⤷ Try a Trial
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-003	Aug 1, 1984	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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