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Serving 500+ biopharmaceutical companies globally:

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Johnson and Johnson
Federal Trade Commission
Daiichi Sankyo
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Deloitte
McKinsey
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Generated: August 21, 2017

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Valsartan - Generic Drug Details

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

Valsartan
is the generic ingredient in two branded drugs marketed by Amneal Pharms, Hetero Labs Ltd V, Prinston Inc, Aurobindo Pharma Ltd, Torrent Pharms Ltd, Ivax Pharms, Jubilant Generics, Watson Labs Inc, Novartis, Mylan Pharms Inc, Alembic Pharms Ltd, Lupin Ltd, Ohm Labs Inc, and Macleods Pharms Ltd, and is included in fifteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Valsartan has eighty-eight patent family members in thirty-three countries.

There are twenty-nine drug master file entries for valsartan. Thirty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: valsartan

Tradenames:2
Patents:2
Applicants:14
NDAs:15
Drug Master File Entries: see list29
Suppliers / Packagers: see list37
Bulk Api Vendors: see list84
Clinical Trials: see list266
Patent Applications: see list5,144
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:valsartan at DailyMed

Pharmacology for Ingredient: valsartan

Tentative approvals for VALSARTAN

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe80MG; 12.5MGTABLET; ORAL
► Subscribe► Subscribe320MG; 25MGTABLET; ORAL
► Subscribe► Subscribe320MG; 12.5MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ohm Labs Inc
VALSARTAN
valsartan
TABLET;ORAL077492-002Jun 26, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-001Jul 18, 2001ABRXYesNo► Subscribe► SubscribeY► Subscribe
Prinston Inc
VALSARTAN
valsartan
TABLET;ORAL204821-004Jun 9, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
VALSARTAN
valsartan
TABLET;ORAL090866-002Jan 5, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Torrent Pharms Ltd
VALSARTAN
valsartan
TABLET;ORAL202728-004Jan 5, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-003Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-001Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 1996► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: valsartan

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,952,305 Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims► Subscribe
6,485,745 Solid oral dosage forms of valsartan► Subscribe
5,977,160 Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims► Subscribe
6,858,228 Solid oral dosage forms of valsartan► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: valsartan

Country Document Number Estimated Expiration
European Patent Office1774967► Subscribe
European Patent Office1262175► Subscribe
South Korea20090099020► Subscribe
Hungary0203374► Subscribe
Israel127564► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: VALSARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2016Austria► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119
90021-9Sweden► SubscribePRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123
C/GB97/009United Kingdom► SubscribePRODUCT NAME: VALSARTAN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 36983.00.00 19960513; DE 36983.01.00 19960513; UK 00001/0218 19961016; UK 00001/0219 19961016; UK 00001/0225 19961016
80036Netherlands► SubscribePRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAARIN R EEN LAAGALKYL-, FENYLLAAGALKYL-, LAAGALKENYL-, LAAGAL- KYNYL-, LAAGALKOXY-LAAGALKYL-, LAAGALKOXY-LAAGALKENYL- OF -----; NAT. REGISTRATION NO/DATE: RVG 22365 19980525; FIRST REGISTRATION: 344 300-5344 301-1344 302-8344 303-4 1997250925
2016017Lithuania► SubscribePRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Citi
QuintilesIMS
Cipla
Merck
Boehringer Ingelheim
Queensland Health
Healthtrust
Johnson and Johnson
Medtronic
Cerilliant

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 verifification 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.

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