HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE - Generic Drug Details

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What are the generic sources for hydrochlorothiazide; metoprolol tartrate and what is the scope of freedom to operate?

Hydrochlorothiazide; metoprolol tartrate is the generic ingredient in two branded drugs marketed by Validus Pharms, Alembic, Mylan, and Sun Pharm Inds, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	5
Clinical Trials:	3
DailyMed Link:	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

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

Sponsor	Phase
Mylan Pharmaceuticals	Phase 1
Vanderbilt University Medical Center	Phase 1
Vanderbilt University	Phase 1

See all HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

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

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

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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
Sun Pharm Inds	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	090654-002	Jan 19, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	202870-001	Nov 6, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	076792-003	Aug 20, 2004	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 HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	⤷ Sign Up	⤷ Sign Up
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984	⤷ Sign Up	⤷ Sign Up
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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