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Generated: June 28, 2017
What is the patent landscape for Diovan, and what generic Diovan 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.| Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 3 |
| Suppliers / Packagers: see list | 10 |
| Bulk Api Vendors: see list | 85 |
| Clinical Trials: see list | 20 |
| Patent Applications: see list | 5,347 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | DIOVAN at DailyMed |
| Drug Class | Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| 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 | |||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-002 | Jul 18, 2001 | AB | RX | Yes | No | 5,972,990*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | AB | RX | Yes | No | 6,294,197*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-002 | Mar 6, 1998 | AB | RX | Yes | No | 6,294,197*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-002 | Jul 18, 2001 | AB | RX | Yes | No | 6,294,197*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-003 | Jul 18, 2001 | 5,399,578*PED | ► Subscribe | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | 5,972,990*PED | ► Subscribe | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-002 | Jul 18, 2001 | 5,399,578*PED | ► Subscribe | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | CAPSULE;ORAL | 020665-001 | Dec 23, 1996 | 5,399,578*PED | ► Subscribe | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | 5,399,578*PED | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| valsartan and hydrochlorothiazide | Tablets | 320 mg/12.5 mg and 320 mg/25 mg | Diovan HCT | 2/7/2007 |
| valsartan and hydrochlorothiazide | Tablets | 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg | Diovan HCT | 12/2/2005 |
| valsartan | Tablets | 40 mg, 80 mg,160 mg | Diovan | 12/28/2004 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,858,228 | Solid oral dosage forms of valsartan | ► Subscribe | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Korea | 100792389 | ► Subscribe | |||||||||||||||||||||||||||
| Indonesia | 17553 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 127564 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 724998 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1767206 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016000037 | Germany | ► Subscribe | PRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSIICH PHARMAZEUTISCH ANNEHMBARER SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119 | ||||||||||||||||||||||||||
| C0039 | Belgium | ► Subscribe | PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513 | ||||||||||||||||||||||||||
| 2016017 | Lithuania | ► Subscribe | PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119 | ||||||||||||||||||||||||||
| 70001 | Netherlands | ► Subscribe | PRODUCT 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 | ||||||||||||||||||||||||||
| C0050 | France | ► Subscribe | PRODUCT NAME: VALSARTAN; REGISTRATION NO/DATE IN FRANCE: NL 22077 DU 19970321; REGISTRATION NO/DATE AT EEC: 369830000 DU 19960513 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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