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Last Updated: March 19, 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
National Institute on Aging (NIA)Phase 4
The New York Community TrustPhase 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
Kvk Tech BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 078962-002 Jun 27, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Kvk Tech BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 078962-001 Jun 27, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 075541-002 Oct 22, 1999 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us KERLONE betaxolol hydrochloride TABLET;ORAL 019507-001 Oct 27, 1989 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
>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
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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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