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Generated: July 22, 2017
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 three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 3 |
| Applicants: | 14 |
| NDAs: | 15 |
| Drug Master File Entries: see list | 29 |
| Suppliers / Packagers: see list | 38 |
| Bulk Api Vendors: see list | 84 |
| Clinical Trials: see list | 266 |
| Patent Applications: see list | 5,144 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | valsartan at DailyMed |
| Drug Class | Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 80MG; 12.5MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 320MG; 25MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 320MG; 12.5MG | TABLET; ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd V | VALSARTAN | valsartan | TABLET;ORAL | 203311-004 | Jan 5, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | AB | RX | Yes | No | 5,972,990*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Lupin Ltd | VALSARTAN | valsartan | TABLET;ORAL | 201677-001 | Jan 5, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Macleods Pharms Ltd | VALSARTAN | valsartan | TABLET;ORAL | 202696-002 | Sep 16, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Jubilant Generics | VALSARTAN | valsartan | TABLET;ORAL | 203536-003 | Jan 5, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-002 | Jul 18, 2001 | 5,972,990*PED | ► Subscribe | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | CAPSULE;ORAL | 020665-001 | Dec 23, 1996 | 5,399,578*PED | ► Subscribe | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-001 | Jul 18, 2001 | 5,399,578*PED | ► Subscribe | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-002 | Jul 18, 2001 | 5,399,578*PED | ► Subscribe | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | 5,399,578*PED | ► Subscribe | ||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Russian Federation | 2294743 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2117782 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | 473394 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2055301 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 195339 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0039 | Belgium | ► Subscribe | PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513 | ||||||||||||||||||||||||||
| 90020-1 | Sweden | ► Subscribe | PRODUCT 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 90021-9 | Sweden | ► Subscribe | PRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
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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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