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Last Updated: September 29, 2020

DrugPatentWatch Database Preview

LABETALOL HYDROCHLORIDE Drug Profile

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Which patents cover Labetalol Hydrochloride, 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-seven 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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SponsorPhase
Assiut UniversityPhase 2
Hamilton Health Sciences CorporationPhase 2
Wright State UniversityPhase 4

See all LABETALOL HYDROCHLORIDE clinical trials

Pharmacology for LABETALOL HYDROCHLORIDE
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
Teva LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 074989-002 Sep 30, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075113-001 Aug 4, 1998 AB RX No No   Start Trial   Start Trial   Start Trial
Akorn Inc LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 075431-001 Nov 29, 1999 AP 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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