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Last Updated: January 18, 2021

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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.

Summary for betaxolol hydrochloride

US Patents:	0
Tradenames:	6
Applicants:	10
NDAs:	11
Drug Master File Entries:	11
Suppliers / Packagers:	7
Bulk Api Vendors:	88
Clinical Trials:	2
Formulation / Manufacturing:	see details
DailyMed Link:	betaxolol hydrochloride at DailyMed

Recent Clinical Trials for betaxolol hydrochloride

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Sponsor	Phase
Ohio State University	Phase 1
University of Oklahoma	Phase 1
The University of Texas Health Science Center, Houston	Phase 1

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

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

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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
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

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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	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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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.

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