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Last Updated: April 20, 2024

LABETALOL HYDROCHLORIDE Drug Patent Profile


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

Labetalol Hydrochloride is a drug marketed by Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience, Appco, Cadila Pharms Ltd, Epic Pharma Llc, Eywa, Heritage Pharma, Innogenix, Par Form, Rubicon, Sandoz, Teva, Unichem, Watson Labs, and Zydus Pharms. and is included in twenty-six NDAs.

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

DrugPatentWatch® 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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Summary for LABETALOL HYDROCHLORIDE
Drug patent expirations by year for LABETALOL HYDROCHLORIDE
Recent Clinical Trials for LABETALOL HYDROCHLORIDE

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SponsorPhase
Loma Linda UniversityN/A
Zagazig UniversityPhase 2
Nebraska Methodist Health SystemPhase 4

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Pharmacology for LABETALOL HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for LABETALOL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes 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
Sandoz LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075113-002 Aug 4, 1998 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Innogenix LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075215-002 Jul 29, 1999 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075133-001 Aug 3, 1998 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 074989-003 Sep 30, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075133-002 Aug 3, 1998 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma LABETALOL HYDROCHLORIDE IN DEXTROSE labetalol hydrochloride SOLUTION;INTRAVENOUS 213330-001 Nov 9, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heritage Pharma LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 074787-001 Aug 3, 1998 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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