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Valsartan - Generic Drug Details
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This ingredient has eighty-eight patent family members in thirty-three countries.
There are twenty-nine drug master file entries for valsartan. Thirty-five suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for Generic Name: valsartan
| Tradenames: | 2 |
| Patents: | 2 |
| Applicants: | 13 |
| NDAs: | 14 |
| Drug Master File Entries: see list | 29 |
| Suppliers / Packaging: see list | 35 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: valsartan
| Drug Class | Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Tentative approvals for VALSARTAN
| Applicant | Application No. | Form | Dosage |
| <disabled> | <disabled> | TABLET; ORAL | 160MG; 25MG |
| <disabled> | <disabled> | TABLET; ORAL | 320MG; 12.5MG |
| <disabled> | <disabled> | TABLET; ORAL | 320MG; 25MG |
Clinical Trials for: valsartan
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amneal Pharms | VALSARTAN | valsartan | TABLET;ORAL | 204011-002 | Jan 11, 2016 | RX | No | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | CAPSULE;ORAL | 020665-001 | Dec 23, 1996 | DISCN | No | ||||||||||||||||||||||
Hetero Labs Ltd V | VALSARTAN | valsartan | TABLET;ORAL | 203311-003 | Jan 5, 2015 | RX | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: valsartan
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | DIOVAN | valsartan | CAPSULE;ORAL | 020665-001 | Dec 23, 1996 | 5,399,578*PED | <disabled> | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | 5,399,578*PED | <disabled> | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-003 | Jul 18, 2001 | 5,399,578*PED | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,858,228 | Solid oral dosage forms of valsartan | <disabled in preview> | |||||||||||||||||||||||||||
| 5,952,305 | Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims | <disabled in preview> | |||||||||||||||||||||||||||
| 5,977,160 | Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims | <disabled in preview> | |||||||||||||||||||||||||||
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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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International Patent Family for Ingredient: valsartan
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Russian Federation | 2009115778 | <disabled in preview> | |||||||||||||||||||||||||||
| Cyprus | 2553 | <disabled in preview> | |||||||||||||||||||||||||||
| Brazil | 9709956 | <disabled in preview> | |||||||||||||||||||||||||||
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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 Certificates for Tradename: VALSARTAN
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00445 | Netherlands | <disabled> | PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016 | ||||||||||||||||||||||||||
| 0443983/03 | Switzerland | <disabled> | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 | ||||||||||||||||||||||||||
| 07C/043 | Belgium | <disabled> | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 | ||||||||||||||||||||||||||
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