Valsartan - Generic Drug Details

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

Valsartan is the generic ingredient in three branded drugs marketed by Novartis, Carmel Biosciences, Novitium Pharma, Alembic, 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, Watson Labs Inc, Zenara, and Zydus Lifesciences, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for valsartan

US Patents:	0
Tradenames:	3
Applicants:	23
NDAs:	24
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	385
Patent Applications:	8,236
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
International Bio service	Phase 1
Dr. Reddy's Laboratories (Thailand) Limited	Phase 1
Unidade de Investigação e Desenvolvimento Cardiovascular (UnIC)	Phase 4

See all valsartan clinical trials

Generic filers with tentative approvals for VALSARTAN

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

Anatomical Therapeutic Chemical (ATC) Classes for valsartan

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

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

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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
Watson Labs Inc	VALSARTAN	valsartan	TABLET;ORAL	090642-001	Jan 5, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	VALSARTAN	valsartan	TABLET;ORAL	205536-001	Mar 12, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	VALSARTAN	valsartan	TABLET;ORAL	205536-003	Mar 12, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	VALSARTAN	valsartan	TABLET;ORAL	203311-004	Jan 5, 2015	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 valsartan

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-004	Aug 14, 2002	⤷ Sign Up	⤷ Sign Up
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-003	Jul 18, 2001	⤷ Sign Up	⤷ Sign Up
Novartis	DIOVAN	valsartan	CAPSULE;ORAL	020665-001	Dec 23, 1996	⤷ Sign Up	⤷ Sign Up
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-002	Jul 18, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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