Make Better Decisions

  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

US Department of Justice
US Army
Mallinckrodt
Accenture
Chinese Patent Office
Fish and Richardson
QuintilesIMS
Dow
Federal Trade Commission
Chubb

Generated: January 19, 2018

DrugPatentWatch Database Preview

DIOVAN Drug Profile

« Back to Dashboard

When do Diovan patents expire, and what generic alternatives are available?

Diovan is a drug marketed by Novartis and is included in three NDAs. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has ninety-six patent family members in thirty-three countries.

The generic ingredient in DIOVAN is hydrochlorothiazide; valsartan. There are thirty-one drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Drug patent expirations by year for DIOVAN
Pharmacology for DIOVAN

US Patents and Regulatory Information for DIOVAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis DIOVAN valsartan CAPSULE;ORAL 020665-001 Dec 23, 1996 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis DIOVAN valsartan TABLET;ORAL 021283-002 Jul 18, 2001 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis DIOVAN valsartan TABLET;ORAL 021283-004 Aug 14, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-002 Mar 6, 1998 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis DIOVAN valsartan TABLET;ORAL 021283-002 Jul 18, 2001 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-003 Jan 17, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis DIOVAN valsartan CAPSULE;ORAL 020665-002 Dec 23, 1996 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis DIOVAN valsartan TABLET;ORAL 021283-004 Aug 14, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis DIOVAN valsartan TABLET;ORAL 021283-001 Jul 18, 2001 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Expired US Patents for DIOVAN

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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Paragraph IV (Patent) Challenges for DIOVAN
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 320 mg/12.5 mg and 320 mg/25 mg ➤ Subscribe 2/7/2007
➤ Subscribe Tablets 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg ➤ Subscribe 12/2/2005
➤ Subscribe Tablets 40 mg, 80 mg,160 mg ➤ Subscribe 12/28/2004

Non-Orange Book US Patents for DIOVAN

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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for DIOVAN

Supplementary Protection Certificates for DIOVAN

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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Novartis
Cantor Fitzgerald
AstraZeneca
Queensland Health
Deloitte
Chubb
Citi
Colorcon
Cipla

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.

botpot