BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE - Generic Drug Details

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What are the generic drug sources for bisoprolol fumarate; hydrochlorothiazide and what is the scope of freedom to operate?

Bisoprolol fumarate; hydrochlorothiazide is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Apothecon, Cadila, Chartwell Rx, Edenbridge Pharms, Epic Pharma Llc, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Mylan, Novitium Pharma, Teva, Unichem, Watson Labs Teva, and Teva Branded Pharm, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound.

Summary for BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	13
DailyMed Link:	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE at DailyMed

Pharmacology for BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Drug Class	Thiazide Diuretic beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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

US Patents and Regulatory Information for BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

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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
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
Epic Pharma Llc	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	075579-001	Sep 25, 2000	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	075686-003	Jan 19, 2001		DISCN	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; HYDROCHLOROTHIAZIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	ZIAC	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	020186-002	Mar 26, 1993	⤷ Sign Up	⤷ Sign Up
Teva Branded Pharm	ZIAC	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	020186-003	Mar 26, 1993	⤷ Sign Up	⤷ Sign Up
Teva Branded Pharm	ZIAC	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	020186-001	Mar 26, 1993	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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