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Last Updated: February 26, 2021

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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 Akorn Inc, Apothecon, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Mylan Asi, West-ward Pharms Int, Schering, Sebela Ireland Ltd, Hikma, Appco, Cadila Pharms Ltd, Epic Pharma Llc, Eywa, Heritage Pharma, Innogenix, Par Form, Sandoz, Teva, Watson Labs, Zydus Pharms, and Cnty Line Pharms, and is included in twenty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for labetalol hydrochloride. Twenty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for labetalol hydrochloride

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

SponsorPhase
Zagazig UniversityPhase 1/Phase 2
Melanie Maykin, MDPhase 3
Assiut UniversityPhase 2

See all labetalol hydrochloride clinical trials

Generic filers with tentative approvals for LABETALOL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial5MG/MLINJECTABLE;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
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
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 074989-001 Sep 30, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare Corp LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 076051-001 Jul 5, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Epic Pharma Llc LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 212990-001 Sep 30, 2020 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

Expired US Patents for labetalol hydrochloride

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

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