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Generated: October 20, 2017

DrugPatentWatch Database Preview

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 ninety-six patent family members in thirty-three countries and twenty-two supplementary protection certificates in eleven countries.

There are thirty 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

US Patents:2
Tradenames:2
Applicants:14
NDAs:15
Drug Master File Entries: see list30
Suppliers / Packagers: see list37
Bulk Api Vendors: see list84
Clinical Trials: see list271
Patent Applications: see list5,297
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
u► Subscribe80MG; 12.5MGTABLET; ORAL
u► Subscribe320MG; 25MGTABLET; ORAL
u► 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
Aurobindo Pharma Ltd
VALSARTAN
valsartan
TABLET;ORAL202223-003Jan 5, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-001Jul 18, 2001ABRXYesNo► Subscribe► SubscribeY► Subscribe
Alembic Pharms Ltd
VALSARTAN
valsartan
TABLET;ORAL091367-002Jan 5, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Ohm Labs Inc
VALSARTAN
valsartan
TABLET;ORAL077492-001Jun 26, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Prinston Inc
VALSARTAN
valsartan
TABLET;ORAL204821-004Jun 9, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Hetero Labs Ltd V
VALSARTAN
valsartan
TABLET;ORAL203311-003Jan 5, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Prinston Inc
VALSARTAN
valsartan
TABLET;ORAL204821-002Jun 9, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Ohm Labs Inc
VALSARTAN
valsartan
TABLET;ORAL077492-003Jun 26, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
VALSARTAN
valsartan
TABLET;ORAL090866-003Jan 5, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001ABRXYesNo► Subscribe► SubscribeY► 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;ORAL021283-003Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 1996► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-001Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 2002► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-003Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 2002► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-002Dec 23, 1996► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-001Jul 18, 2001► 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
6,858,228 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
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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
Argentina008618► Subscribe
Slovakia178498► Subscribe
European Patent Office1767206► Subscribe
Brazil9709956► Subscribe
Slovenia1410797► Subscribe
South Korea20060079260► Subscribe
Norway986056► Subscribe
European Patent Office1262175► Subscribe
Denmark1410797► Subscribe
Cyprus2553► 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
2016 00022Denmark► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, HERUNDER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123
/2016Austria► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
C004Belgium► SubscribePRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925
0443983/02Switzerland► SubscribePRODUCT NAME: VALSARTAN UND AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57771 22.12.2006
C0050France► SubscribePRODUCT NAME: VALSARTAN; REGISTRATION NO/DATE IN FRANCE: NL 22077 DU 19970321; REGISTRATION NO/DATE AT EEC: 369830000 DU 19960513
/1997Austria► SubscribePRODUCT NAME: VALSARTAN ODER EIN PHARMAZEUTISCH VERWENDBARES SALZ ODER EIN ESTER DAVON; NAT. REGISTRATION NO/DATE: 1-21751 UND 1-21752 19961220; FIRST REGISTRATION: DE 36983.00.00 36983.01.00 19960513
2016 00023Denmark► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN SOM SACUBITRIL-VALSARTAN-NATRIUMSALTKOMPLEKS; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123
90020-1Sweden► SubscribePRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
074Luxembourg► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; FIRST REGISTRATION DATE: 20151123
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Serving leading biopharmaceutical companies globally:

UBS
Medtronic
Boehringer Ingelheim
Cantor Fitzgerald
Accenture
Express Scripts
McKesson
Argus Health
Queensland Health
Chubb

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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