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 Speclts, Schering, Sebela Ireland Ltd, Andas 5 Holding, Appco, Cadila Pharms Ltd, Endo Operations, Epic Pharma Llc, Heritage Pharma, Hibrow Hlthcare, 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 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:	40
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	69
Patent Applications:	1,197
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
Boston Medical Center	Phase 4
Marshall University	Phase 2
Loma Linda University	N/A

See all labetalol hydrochloride clinical trials

Generic filers with tentative approvals for LABETALOL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for labetalol hydrochloride

C07AG	Alpha and beta blocking agents
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

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
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-001	May 24, 1985		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	labetalol hydrochloride	SOLUTION;INTRAVENOUS	213330-002	Nov 9, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	labetalol hydrochloride	SOLUTION;INTRAVENOUS	213330-003	Nov 9, 2020		RX	Yes	Yes	⤷ 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

Expired US Patents for labetalol hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-003	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-002	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-001	Aug 31, 1987	⤷ Sign Up	⤷ Sign Up
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-004	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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