BISOPROLOL FUMARATE - Generic Drug Details

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, Unichem, United Res Labs, 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
Laval University	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rubicon	BISOPROLOL FUMARATE	bisoprolol fumarate	TABLET;ORAL	075643-002	Nov 16, 2000	AB	RX	No	No
Teva Pharms	BISOPROLOL FUMARATE	bisoprolol fumarate	TABLET;ORAL	075644-002	Jun 26, 2001		DISCN	No	No
Cadila	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	215666-003	Nov 4, 2022	AB	RX	No	No
Edenbridge Pharms	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	212678-001	Jul 9, 2020	AB	RX	No	No
Teva Womens	ZEBETA	bisoprolol fumarate	TABLET;ORAL	019982-002	Jul 31, 1992		DISCN	Yes	No
Epic Pharma Llc	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	075579-001	Sep 25, 2000	AB	RX	No	No
Mylan	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	075768-001	Sep 25, 2000	AB	RX	No	No

Expired US Patents for BISOPROLOL FUMARATE

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