Valsartan - Generic Drug Details

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

Valsartan is the generic ingredient in three branded drugs marketed by Novartis, Carmel Biosciences, Novitium Pharma, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan, Ohm Labs Inc, Prinston Inc, Sciegen Pharms Inc, Square Pharms, Torrent, Unichem, and Watson Labs Inc, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are forty drug master file entries for valsartan. Twenty-four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for valsartan

US Patents:	0
Tradenames:	3
Applicants:	21
NDAs:	22
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	376
Patent Applications:	7,210
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for valsartan
Drug Sales Revenues:	Drug sales revenues for valsartan
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for valsartan
What excipients (inactive ingredients) are in valsartan?	valsartan excipients list
DailyMed Link:	valsartan at DailyMed

See drug prices for valsartan

See drug sales revenues for valsartan

Recent Clinical Trials for valsartan

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

Sponsor	Phase
Instituto Nacional de Cardiologia Ignacio Chavez	Phase 2/Phase 3
Boehringer Ingelheim laboratory	Phase 2/Phase 3
Medical Research Agency	Phase 4

See all valsartan clinical trials

Generic filers with tentative approvals for VALSARTAN

Applicant	Application No.	Strength	Dosage Form
		320MG; 25MG	TABLET; ORAL
		320MG; 12.5MG	TABLET; ORAL
		160MG; 25MG	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 valsartan

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for valsartan

Angiotensin II Type 1 Receptor Blockers

Antihypertensive Agents

Paragraph IV (Patent) Challenges for VALSARTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DIOVAN	Tablets	valsartan	40 mg, 80 mg, 160 mg and 320 mg	021283	1	2004-12-28

US Patents and Regulatory Information for valsartan

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	valsartan	TABLET;ORAL	202696-001	Sep 16, 2016	AB	RX	No	No
Square Pharms	VALSARTAN	valsartan	TABLET;ORAL	205347-002	Apr 9, 2018	AB	RX	No	No
Sciegen Pharms Inc	VALSARTAN	valsartan	TABLET;ORAL	204038-002	Oct 27, 2021	AB	RX	No	No

Expired US Patents for valsartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-002	Jul 18, 2001
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-001	Jul 18, 2001
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-001	Jul 18, 2001