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Last Updated: July 13, 2020

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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.

Recent Clinical Trials for betaxolol hydrochloride

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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
Kvk Tech BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 078962-001 Jun 27, 2008 AB RX 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
Apotex Inc BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 075446-001 Sep 28, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us KERLONE betaxolol hydrochloride TABLET;ORAL 019507-002 Oct 27, 1989 DISCN 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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Colorcon
Dow
Medtronic
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.