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Serving leading biopharmaceutical companies globally:

US Army
Novartis
US Department of Justice
Express Scripts
McKesson
Covington
Chinese Patent Office
AstraZeneca
QuintilesIMS
Moodys

Generated: January 19, 2018

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.

There are thirty-five 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
➤ Subscribe➤ Subscribe80MG; 12.5MGTABLET; ORAL
➤ Subscribe➤ Subscribe320MG; 25MGTABLET; ORAL
➤ Subscribe➤ Subscribe320MG; 12.5MGTABLET; ORAL

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
Torrent Pharms Ltd VALSARTAN valsartan TABLET;ORAL 202728-004 Jan 5, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Aurobindo Pharma Ltd VALSARTAN valsartan TABLET;ORAL 202223-004 Jan 5, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Lupin Ltd VALSARTAN valsartan TABLET;ORAL 201677-001 Jan 5, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hetero Labs Ltd V VALSARTAN valsartan TABLET;ORAL 203311-004 Jan 5, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Macleods Pharms Ltd VALSARTAN valsartan TABLET;ORAL 202696-004 Sep 16, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Alembic Pharms Ltd VALSARTAN valsartan TABLET;ORAL 091367-003 Jan 5, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis DIOVAN valsartan TABLET;ORAL 021283-004 Aug 14, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Ohm Labs Inc VALSARTAN valsartan TABLET;ORAL 077492-001 Jun 26, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis DIOVAN valsartan CAPSULE;ORAL 020665-002 Dec 23, 1996 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis DIOVAN valsartan TABLET;ORAL 021283-001 Jul 18, 2001 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for valsartan

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

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Non-Orange Book US Patents for 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
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
6,485,745 Solid oral dosage forms of valsartan ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for valsartan

Supplementary Protection Certificates for valsartan

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90021-9 Sweden ➤ Subscribe PRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123
/2016 Austria ➤ Subscribe PRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119
C0050 France ➤ Subscribe PRODUCT NAME: VALSARTAN; REGISTRATION NO/DATE IN FRANCE: NL 22077 DU 19970321; REGISTRATION NO/DATE AT EEC: 369830000 DU 19960513
00445 Netherlands ➤ Subscribe PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
80036 Netherlands ➤ Subscribe PRODUCT 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
0811 Netherlands ➤ Subscribe PRODUCT NAME: SACUBITRIL/VALSARTAN, MET INBEGRIP VAN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123
C/GB97/009 United Kingdom ➤ Subscribe PRODUCT 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
C0039 Belgium ➤ Subscribe PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513
2016000037 Germany ➤ Subscribe PRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119
C0019 France ➤ Subscribe PRODUCT NAME: SACUBITRIL/VALSARTAN,Y COMPRIS LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1058 20151123
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Fuji
Daiichi Sankyo
QuintilesIMS
Argus Health
McKesson
Deloitte
McKinsey
Novartis

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