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Last Updated: March 28, 2024

BETAXOLOL HYDROCHLORIDE - Generic Drug Details


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What are the generic 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 Acella, Akorn, Apotex Inc, Medimetriks Pharms, 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.

There are nine drug master file entries for betaxolol hydrochloride. Six suppliers are listed for this compound.

Summary for BETAXOLOL HYDROCHLORIDE
Recent Clinical Trials for BETAXOLOL HYDROCHLORIDE

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

SponsorPhase
Zagazig UniversityPhase 2
Weill Medical College of Cornell UniversityPhase 4
National Institute on Aging (NIA)Phase 4

See all BETAXOLOL HYDROCHLORIDE clinical trials

Pharmacology for BETAXOLOL HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for BETAXOLOL HYDROCHLORIDE

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
Novartis BETOPTIC S betaxolol hydrochloride SUSPENSION/DROPS;OPHTHALMIC 019845-001 Dec 29, 1989 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 075446-001 Sep 28, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Akorn BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 075386-001 Jun 30, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985 AT RX Yes Yes ⤷  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 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 ⤷  Try a Trial ⤷  Try a Trial
Sandoz BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985 ⤷  Try a Trial ⤷  Try a Trial
Novartis BETOPTIC S betaxolol hydrochloride SUSPENSION/DROPS;OPHTHALMIC 019845-001 Dec 29, 1989 ⤷  Try a Trial ⤷  Try a Trial
Novartis BETOPTIC S betaxolol hydrochloride SUSPENSION/DROPS;OPHTHALMIC 019845-001 Dec 29, 1989 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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