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Last Updated: January 18, 2021

DrugPatentWatch Database Preview

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 Akorn, Apotex Inc, Medimetriks Pharms, Wockhardt, Sandoz Inc, 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 eleven drug master file entries for betaxolol hydrochloride. Seven 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
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
Sanofi Aventis Us KERLEDEX betaxolol hydrochloride; chlorthalidone TABLET;ORAL 019807-001 Oct 30, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us KERLEDEX betaxolol hydrochloride; chlorthalidone TABLET;ORAL 019807-002 Oct 30, 1992 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
Wockhardt BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 078694-001 Nov 16, 2009 AT RX No No   Start Trial   Start Trial   Start Trial
Akorn BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 075386-001 Jun 30, 2000 AT RX No No   Start Trial   Start Trial   Start Trial
Alcon BETOPTIC PILO betaxolol hydrochloride; pilocarpine hydrochloride SUSPENSION/DROPS;OPHTHALMIC 020619-001 Apr 17, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Epic Pharma BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 075541-002 Oct 22, 1999 AB RX No Yes   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
Novartis BETOPTIC S betaxolol hydrochloride SUSPENSION/DROPS;OPHTHALMIC 019845-001 Dec 29, 1989   Start Trial   Start Trial
Sandoz Inc BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985   Start Trial   Start Trial
Sandoz Inc BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985   Start Trial   Start Trial
Novartis BETOPTIC S betaxolol hydrochloride SUSPENSION/DROPS;OPHTHALMIC 019845-001 Dec 29, 1989   Start Trial   Start Trial
Sandoz Inc BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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