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Generated: June 28, 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Pharms Inc | VALSARTAN | valsartan | TABLET;ORAL | 090866-001 | Jan 5, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Ivax Pharms | VALSARTAN | valsartan | TABLET;ORAL | 077530-003 | Jan 4, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Lupin Ltd | VALSARTAN | valsartan | TABLET;ORAL | 201677-002 | Jan 5, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Jubilant Generics | VALSARTAN | valsartan | TABLET;ORAL | 203536-001 | Jan 5, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Alembic Pharms Ltd | VALSARTAN | valsartan | TABLET;ORAL | 091367-001 | 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 | 021283-003 | 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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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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