Hydrochlorothiazide; valsartan - Generic Drug Details

✉ Email this page to a colleague

What are the generic drug sources for hydrochlorothiazide; valsartan and what is the scope of patent protection?

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Macleods Pharms Ltd	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	203145-003	Apr 19, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	204382-004	Aug 11, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	202519-003	Mar 21, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Pharms Inc	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	078020-005	Sep 21, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	204382-002	Aug 11, 2023	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; valsartan

Subscribe to access the full database, or Sign Up
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
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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.