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Last Updated: August 13, 2020

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Labetalol hydrochloride - Generic Drug Details

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

Labetalol hydrochloride is the generic ingredient in three branded drugs marketed by Akorn Inc, Apothecon, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Mylan Asi, West-ward Pharms Int, Schering, Sebela Ireland Ltd, Athem, Cadila Pharms Ltd, Heritage Pharma, Innogenix, Par Form, Sandoz, Teva, Twi Pharms, Watson Labs, Zydus Pharms, and Cnty Line Pharms, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for labetalol hydrochloride. Twenty-six 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
Assiut UniversityPhase 2
Wright State UniversityPhase 4
Medical College of WisconsinN/A

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
Twi Pharms LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 209603-002 Jun 20, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-004 Aug 1, 1984 DISCN Yes No   Start Trial   Start Trial   Start Trial
Cadila Pharms Ltd LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 211325-002 May 13, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-001 Aug 31, 1987 DISCN Yes No   Start Trial   Start Trial   Start Trial
Akorn Inc LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 075524-001 Nov 29, 1999 DISCN 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
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-001 Aug 31, 1987   Start Trial   Start Trial
Cnty Line Pharms TRANDATE labetalol hydrochloride TABLET;ORAL 018716-003 Aug 1, 1984   Start Trial   Start Trial
Cnty Line Pharms TRANDATE labetalol hydrochloride TABLET;ORAL 018716-001 May 24, 1985   Start Trial   Start Trial
Schering NORMODYNE labetalol hydrochloride INJECTABLE;INJECTION 018686-001 Aug 1, 1984   Start Trial   Start Trial
Cnty Line Pharms TRANDATE labetalol hydrochloride TABLET;ORAL 018716-001 May 24, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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