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Last Updated: August 9, 2020

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When do Labetalol Hydrochloride patents expire, and what generic alternatives are available?

Labetalol Hydrochloride is a drug marketed by Akorn Inc, Apothecon, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Mylan Asi, West-ward Pharms Int, Athem, Cadila Pharms Ltd, Heritage Pharma, Innogenix, Par Form, Sandoz, Teva, Twi Pharms, Watson Labs, and Zydus Pharms. and is included in twenty-one NDAs.

The generic ingredient in LABETALOL HYDROCHLORIDE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Labetalol Hydrochloride

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

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Drug patent expirations by year for LABETALOL HYDROCHLORIDE
Recent Clinical Trials for LABETALOL HYDROCHLORIDE

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Assiut UniversityPhase 2
Wright State UniversityPhase 4
Medical College of WisconsinN/A

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Medical Subject Heading (MeSH) Categories for LABETALOL HYDROCHLORIDE

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
Zydus Pharms LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 207743-001 Sep 19, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Teva LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 074989-001 Sep 30, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Par Form LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 200908-003 Jul 10, 2012 AB RX 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

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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. 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.