Last Updated: May 3, 2026

betaxolol hydrochloride - Profile


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What are the generic drug sources for betaxolol hydrochloride and what is the scope of freedom to operate?

Betaxolol hydrochloride is the generic ingredient in six branded drugs marketed by Apotex Inc, Chartwell Rx, Eurofarma, Pharmobedient, Sandoz, Novartis, Epic Pharma, Kvk Tech, Sanofi Aventis Us, and Alcon, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Summary for betaxolol hydrochloride
US Patents:0
Tradenames:6
Applicants:10
NDAs:11

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
Apotex Inc BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 075446-001 Sep 28, 2000 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Chartwell Rx BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 078694-001 Nov 16, 2009 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Eurofarma 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

Expired US Patents for betaxolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985 4,342,783 ⤷  Start Trial
Sandoz BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985 4,252,984 ⤷  Start Trial
Novartis BETOPTIC S betaxolol hydrochloride SUSPENSION/DROPS;OPHTHALMIC 019845-001 Dec 29, 1989 4,342,783 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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