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Serving leading biopharmaceutical companies globally:

Moodys
Healthtrust
Queensland Health
Fuji
QuintilesIMS
Merck
UBS
Johnson and Johnson
Citi
Medtronic

Generated: January 17, 2018

DrugPatentWatch Database Preview

Labetalol hydrochloride - Generic Drug Details

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What are the generic sources for labetalol hydrochloride and what is the scope of labetalol hydrochloride patent protection?

Labetalol hydrochloride
is the generic ingredient in three branded drugs marketed by Akorn Inc, Apothecon, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Sagent Agila Llc, West-ward Pharms Int, Schering, Sebela Ireland Ltd, Innogenix, Ivax Sub Teva Pharms, Par Form, Sandoz, Teva, Watson Labs, Zydus Pharms Usa Inc, and Cnty Line Pharms, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for labetalol hydrochloride. Thirty-six suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for labetalol hydrochloride
Medical Subject Heading (MeSH) Categories for labetalol hydrochloride
Tentative approvals for LABETALOL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe5MG/MLINJECTABLE;INJECTION

US Patents and Regulatory Information for labetalol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apothecon LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075223-003 Nov 20, 1998 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Form LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 200908-002 Jul 10, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Zydus Pharms Usa Inc LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 207743-003 Sep 19, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 074989-003 Sep 30, 1998 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Akorn Inc LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 075431-001 Nov 29, 1999 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apothecon LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075223-002 Nov 20, 1998 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apothecon LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075223-001 Nov 20, 1998 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sagent Agila Llc LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 079134-001 Feb 3, 2010 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Zydus Pharms Usa Inc LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 207743-002 Sep 19, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hospira LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 075240-001 Nov 29, 1999 AP RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for labetalol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd TRANDATE labetalol hydrochloride INJECTABLE;INJECTION 019425-001 Dec 31, 1985 ➤ Subscribe ➤ Subscribe
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-003 Aug 1, 1984 ➤ Subscribe ➤ Subscribe
Cnty Line Pharms TRANDATE labetalol hydrochloride TABLET;ORAL 018716-003 Aug 1, 1984 ➤ Subscribe ➤ Subscribe
Schering NORMODYNE labetalol hydrochloride INJECTABLE;INJECTION 018686-001 Aug 1, 1984 ➤ Subscribe ➤ Subscribe
Cnty Line Pharms TRANDATE labetalol hydrochloride TABLET;ORAL 018716-004 Aug 1, 1984 ➤ Subscribe ➤ Subscribe
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-002 Aug 1, 1984 ➤ Subscribe ➤ Subscribe
Cnty Line Pharms TRANDATE labetalol hydrochloride TABLET;ORAL 018716-001 May 24, 1985 ➤ Subscribe ➤ Subscribe
Cnty Line Pharms TRANDATE labetalol hydrochloride TABLET;ORAL 018716-001 May 24, 1985 ➤ Subscribe ➤ Subscribe
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-004 Aug 1, 1984 ➤ Subscribe ➤ Subscribe
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-004 Aug 1, 1984 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Covington
US Department of Justice
Fish and Richardson
US Army
Accenture
Healthtrust
Argus Health
Harvard Business School
Deloitte

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. thinkBiotech performs no independent verifification 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.

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