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Last Updated: November 2, 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, Apotex Inc, Medimetriks Pharms, Sciegen Pharms Inc, 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. Five suppliers are listed for this compound.

Summary for BETAXOLOL HYDROCHLORIDE
US Patents:0
Tradenames:6
Applicants:10
NDAs:11
Drug Master File Entries: 9
Finished Product Suppliers / Packagers: 5
Raw Ingredient (Bulk) Api Vendors: 123
Clinical Trials: 5
Patent Applications: 2,554
What excipients (inactive ingredients) are in BETAXOLOL HYDROCHLORIDE?BETAXOLOL HYDROCHLORIDE excipients list
DailyMed Link:BETAXOLOL HYDROCHLORIDE at DailyMed
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
Sanofi Aventis Us KERLEDEX betaxolol hydrochloride; chlorthalidone TABLET;ORAL 019807-002 Oct 30, 1992 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Kvk Tech BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 078962-001 Jun 27, 2008 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us KERLONE betaxolol hydrochloride TABLET;ORAL 019507-001 Oct 27, 1989 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us KERLEDEX betaxolol hydrochloride; chlorthalidone TABLET;ORAL 019807-001 Oct 30, 1992 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Epic Pharma BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 075541-002 Oct 22, 1999 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex Inc BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 075446-001 Sep 28, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Novartis BETOPTIC S betaxolol hydrochloride SUSPENSION/DROPS;OPHTHALMIC 019845-001 Dec 29, 1989 ⤷  Sign Up ⤷  Sign Up
Sandoz BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985 ⤷  Sign Up ⤷  Sign Up
Sandoz BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985 ⤷  Sign Up ⤷  Sign Up
Sandoz BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985 ⤷  Sign Up ⤷  Sign Up
Novartis BETOPTIC S betaxolol hydrochloride SUSPENSION/DROPS;OPHTHALMIC 019845-001 Dec 29, 1989 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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