HYDROCHLOROTHIAZIDE; VALSARTAN - Generic Drug Details

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

Hydrochlorothiazide; valsartan is the generic ingredient in two branded drugs marketed by Novartis, Alembic, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Watson Labs Teva, and Zydus Lifesciences, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Nineteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for HYDROCHLOROTHIAZIDE; VALSARTAN

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	43
Patent Applications:	446
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HYDROCHLOROTHIAZIDE; VALSARTAN
DailyMed Link:	HYDROCHLOROTHIAZIDE; VALSARTAN at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; VALSARTAN

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

Sponsor	Phase
Farma de Colombia SA	Phase 3
Damanhour University	N/A
University of Birmingham	Phase 3

See all HYDROCHLOROTHIAZIDE; VALSARTAN clinical trials

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE; VALSARTAN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	25MG;320MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	12.5MG;320MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	25MG;160MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for HYDROCHLOROTHIAZIDE; VALSARTAN

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE; VALSARTAN

Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; VALSARTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DIOVAN HCT	Tablets	hydrochlorothiazide; valsartan	320 mg/12.5 mg and 320 mg/25 mg	020818	1	2007-02-07
DIOVAN HCT	Tablets	hydrochlorothiazide; valsartan	80 mg/12.5 mg 160 mg/12.5 mg 160 mg/25 mg	020818	1	2005-12-02

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; VALSARTAN

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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
Alembic	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	201662-005	Mar 21, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	206083-003	Feb 8, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	206083-002	Feb 8, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Lifesciences	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	203000-004	Mar 15, 2019		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 HYDROCHLOROTHIAZIDE; VALSARTAN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-001	Mar 6, 1998	⤷ Sign Up	⤷ Sign Up
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-002	Mar 6, 1998	⤷ Sign Up	⤷ Sign Up
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-004	Apr 28, 2006	⤷ Sign Up	⤷ Sign Up
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-003	Jan 17, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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