Last Updated: November 8, 2026

BETAXOLOL HYDROCHLORIDE - Generic Drug Details

Name: BETAXOLOL HYDROCHLORIDE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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 Apotex Inc, Chartwell Rx, Eurofarma, Pharmobedient, 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.

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:	99
Clinical Trials:	6
Patent Applications:	2,937
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
Queen Mary Hospital, Hong Kong	PHASE3
Zagazig University	Phase 2
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

Anatomical Therapeutic Chemical (ATC) Classes for BETAXOLOL HYDROCHLORIDE

C07AB	Beta blocking agents, selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

S01ED	Beta blocking agents
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Epic Pharma	BETAXOLOL HYDROCHLORIDE	betaxolol hydrochloride	TABLET;ORAL	075541-001	Oct 22, 1999	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Eurofarma	BETAXOLOL HYDROCHLORIDE	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	075630-001	Apr 12, 2001	AT	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Kvk Tech	BETAXOLOL HYDROCHLORIDE	betaxolol hydrochloride	TABLET;ORAL	078962-001	Jun 27, 2008	AB	RX	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
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985	AT	RX	Yes	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

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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	4,342,783	⤷ Start Trial
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985	4,252,984	⤷ Start Trial
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985	4,342,783	⤷ Start Trial
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985	4,311,708	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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