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Last Updated: January 20, 2021

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BETAXOLOL HYDROCHLORIDE Drug Profile

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

Betaxolol Hydrochloride is a drug marketed by Akorn, Apotex Inc, Medimetriks Pharms, Wockhardt, Epic Pharma, and Kvk Tech. and is included in six NDAs.

The generic ingredient in BETAXOLOL HYDROCHLORIDE is betaxolol hydrochloride. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the betaxolol hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Betaxolol Hydrochloride

A generic version of BETAXOLOL HYDROCHLORIDE was approved as betaxolol hydrochloride by EPIC PHARMA on October 22nd, 1999.

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Summary for BETAXOLOL HYDROCHLORIDE
Drug patent expirations by year for BETAXOLOL HYDROCHLORIDE
Recent Clinical Trials for BETAXOLOL HYDROCHLORIDE

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SponsorPhase
Ohio State UniversityPhase 1
University of OklahomaPhase 1
The University of Texas Health Science Center, HoustonPhase 1

See all BETAXOLOL HYDROCHLORIDE clinical trials

Pharmacology for BETAXOLOL HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for BETAXOLOL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for BETAXOLOL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
BETOPTIC SOLUTION/DROPS;OPHTHALMIC betaxolol hydrochloride 019270

US Patents and Regulatory Information for BETAXOLOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 075386-001 Jun 30, 2000 AT RX No No   Start Trial   Start Trial   Start Trial
Kvk Tech BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 078962-001 Jun 27, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Wockhardt BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 078694-001 Nov 16, 2009 AT RX No No   Start Trial   Start Trial   Start Trial
Kvk Tech BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 078962-002 Jun 27, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 075446-001 Sep 28, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Medimetriks Pharms BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 075630-001 Apr 12, 2001 AT 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Express Scripts
Merck

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