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Last Updated: April 20, 2024

Betaxolol hydrochloride - Generic Drug Details

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What are the generic drug sources for betaxolol hydrochloride and what is the scope of patent protection?

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

US Patents:	0
Tradenames:	6
Applicants:	10
NDAs:	11
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	5
Patent Applications:	2,554
Formulation / Manufacturing:	see details
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

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

See all betaxolol hydrochloride clinical trials

Pharmacology for betaxolol hydrochloride

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for betaxolol hydrochloride

Adrenergic beta-1 Receptor Antagonists
Antihypertensive Agents
Sympatholytics

US Patents and Regulatory Information for betaxolol hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon	BETOPTIC PILO	betaxolol hydrochloride; pilocarpine hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	020619-001	Apr 17, 1997		DISCN	No	No	⤷ 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
Sanofi Aventis Us	KERLONE	betaxolol hydrochloride	TABLET;ORAL	019507-002	Oct 27, 1989		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

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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