BISOPROLOL FUMARATE - Generic Drug Details

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What are the generic sources for bisoprolol fumarate and what is the scope of patent protection?

Bisoprolol fumarate is the generic ingredient in four branded drugs marketed by Alembic, Aurobindo Pharma, Dash Pharms Natco, Harman Finochem, Novitium Pharma, Prinston Inc, Rubicon, Teva Pharms, Trupharma, Unichem, Zydus Lifesciences, Teva Womens, Actavis Elizabeth, Apothecon, Cadila, Chartwell Rx, Edenbridge Pharms, Epic Pharma Llc, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Mylan, Teva, Watson Labs Teva, and Teva Branded Pharm, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for bisoprolol fumarate. Twenty-one suppliers are listed for this compound.

Summary for BISOPROLOL FUMARATE

US Patents:	0
Tradenames:	4
Applicants:	24
NDAs:	26
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	212
Clinical Trials:	8
Patent Applications:	5,665
Drug Prices:	Drug price trends for BISOPROLOL FUMARATE
What excipients (inactive ingredients) are in BISOPROLOL FUMARATE?	BISOPROLOL FUMARATE excipients list
DailyMed Link:	BISOPROLOL FUMARATE at DailyMed

See drug prices for BISOPROLOL FUMARATE

Recent Clinical Trials for BISOPROLOL FUMARATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Alexandria University	Phase 2
Damanhour University	Phase 2
Université de Sherbrooke	N/A

See all BISOPROLOL FUMARATE clinical trials

Pharmacology for BISOPROLOL FUMARATE

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

Medical Subject Heading (MeSH) Categories for BISOPROLOL FUMARATE

Adrenergic beta-1 Receptor Antagonists
Antihypertensive Agents
Sympatholytics

Anatomical Therapeutic Chemical (ATC) Classes for BISOPROLOL FUMARATE

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

US Patents and Regulatory Information for BISOPROLOL FUMARATE

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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
Prinston Inc	BISOPROLOL FUMARATE	bisoprolol fumarate	TABLET;ORAL	217368-001	Jul 14, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Sub Teva Pharms	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	075632-001	Sep 27, 2000		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Edenbridge Pharms	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	212678-002	Jul 9, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 BISOPROLOL FUMARATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Womens	ZEBETA	bisoprolol fumarate	TABLET;ORAL	019982-002	Jul 31, 1992	⤷ Sign Up	⤷ Sign Up
Teva Womens	ZEBETA	bisoprolol fumarate	TABLET;ORAL	019982-001	Jul 31, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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