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Last Updated: March 29, 2024

Labetalol hydrochloride - Generic Drug Details


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What are the generic drug 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 Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience, Schering, Sebela Ireland Ltd, Appco, Cadila Pharms Ltd, Epic Pharma Llc, Eywa, Heritage Pharma, Innogenix, Par Form, Rubicon, Sandoz, Teva, Unichem, Watson Labs, Zydus Pharms, and Alvogen, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for labetalol hydrochloride. Forty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for labetalol hydrochloride
Recent Clinical Trials for labetalol hydrochloride

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

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

See all labetalol hydrochloride clinical trials

Generic filers with tentative approvals for LABETALOL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a 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
Hikma LABETALOL HYDROCHLORIDE labetalol hydrochloride SOLUTION;INTRAVENOUS 213330-005 Mar 18, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eywa LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 207863-003 Feb 4, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apothecon LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075223-001 Nov 20, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cadila Pharms Ltd LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 211325-003 May 13, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Steriscience LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 079134-001 Feb 3, 2010 DISCN 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

Expired US Patents for labetalol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen TRANDATE labetalol hydrochloride TABLET;ORAL 018716-002 Aug 1, 1984 ⤷  Try a Trial ⤷  Try a Trial
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-004 Aug 1, 1984 ⤷  Try a Trial ⤷  Try a Trial
Schering NORMODYNE labetalol hydrochloride INJECTABLE;INJECTION 018686-001 Aug 1, 1984 ⤷  Try a Trial ⤷  Try a Trial
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-003 Aug 1, 1984 ⤷  Try a Trial ⤷  Try a Trial
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-004 Aug 1, 1984 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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