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Express Scripts
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Johnson and Johnson
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Generated: December 12, 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 Novartis, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Ohm Labs Inc, Prinston Inc, Torrent Pharms Ltd, and Watson Labs Inc, 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-six suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for valsartan

Medical Subject Heading (MeSH) Categories for 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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Prinston IncVALSARTANvalsartanTABLET;ORAL204821-001Jun 9, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-001Jul 18, 2001ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Hetero Labs Ltd VVALSARTANvalsartanTABLET;ORAL203311-001Jan 5, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncVALSARTANvalsartanTABLET;ORAL090866-004Jan 5, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Torrent Pharms LtdVALSARTANvalsartanTABLET;ORAL202728-001Jan 5, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Jubilant GenericsVALSARTANvalsartanTABLET;ORAL203536-004Jan 5, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
NovartisDIOVANvalsartanCAPSULE;ORAL020665-002Dec 23, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncVALSARTANvalsartanTABLET;ORAL090866-002Jan 5, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Ivax PharmsVALSARTANvalsartanTABLET;ORAL077530-002Jan 4, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Ohm Labs IncVALSARTANvalsartanTABLET;ORAL077492-002Jun 26, 2014ABRXNoNo► Subscribe► 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
NovartisDIOVANvalsartanTABLET;ORAL021283-001Jul 18, 2001► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-003Jul 18, 2001► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-002Jul 18, 2001► Subscribe► Subscribe
NovartisDIOVANvalsartanCAPSULE;ORAL020665-001Dec 23, 1996► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-001Jul 18, 2001► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-004Aug 14, 2002► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-002Jul 18, 2001► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-004Aug 14, 2002► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-003Jul 18, 2001► Subscribe► Subscribe
NovartisDIOVANvalsartanCAPSULE;ORAL020665-002Dec 23, 1996► 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
6,858,228 Solid oral dosage forms of valsartan► 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
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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
Russian Federation2009115778► Subscribe
Austria446749► Subscribe
Denmark0914119► Subscribe
Japan2012051948► Subscribe
Canada2117782► Subscribe
Norway986056► Subscribe
South Korea100618038► Subscribe
Russian Federation2453306► Subscribe
Russian Federation2013113610► Subscribe
Denmark1767206► 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
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
00445Netherlands► SubscribePRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
/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
70001Netherlands► SubscribePRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM V AN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAA RIN R EEN LAAGALKYL-, FENYLLAAGALKYL-,LAAGALKENYL-,LAAGALKYNYL- ,LAAGALKOXY-LAAGALKYL-,LAAGALKOXY-LAAGALKENYL-OF LAAGALKOXY-LAA; NAT. REGISTRATION NO/DATE: RVG 20667, RVG 20668 19961104; FIRST REGISTRATION: 36983.00.00, 36983.01.00 19960513
0811Netherlands► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, MET INBEGRIP VAN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION 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
/2016Austria► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119
0810Netherlands► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIURA (3-((LS,3R)-L-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-L-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-ETHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123
0443983/02Switzerland► SubscribePRODUCT NAME: VALSARTAN UND AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57771 22.12.2006
2016000038Germany► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. TRINATRIUM-(3-((1 S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAT-(S)-3'-METHYL-2'-(PENTANOYL-(2"-(TETRAZOL-5-YLAT)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRAT)-HEMIPENTAHYDRAT.; REGISTRATION NO/DATE: EU/1/15/1058 20151119
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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
Cipla
Chubb
Farmers Insurance
US Department of Justice
QuintilesIMS
McKinsey
Accenture
Moodys

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