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EXFORGE Drug Profile
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This drug has eighty patent family members in thirty-three countries.
The generic ingredient in EXFORGE is amlodipine besylate; hydrochlorothiazide; valsartan. There are forty-eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for Tradename: EXFORGE
| Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 3 |
| Formulation / Manufacturing: | see details |
| Drug Prices: : | see details |
Pharmacology for Tradename: EXFORGE
| Ingredient-type | Dihydropyridines |
| Drug Class | Dihydropyridine Calcium Channel Blocker Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Calcium Channel Antagonists Angiotensin 2 Receptor Antagonists |
Clinical Trials for: EXFORGE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | RX | No | 6,395,728 | Jul 8, 2019 | Y | |||||||||||||||||||
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | RX | No | 8,101,599 | May 16, 2023 | Y | |||||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | RX | Yes | 6,395,728 | Jul 8, 2019 | Y | |||||||||||||||||||
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Expired Patents for Tradename: EXFORGE
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | 5,399,578*PED | <disabled> | ||||||||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | 5,399,578*PED | <disabled> | ||||||||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-003 | Jun 20, 2007 | 5,399,578*PED | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: EXFORGE
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| amlodipine, hydrochlorothiazide and valsartan | Tablets | 10 mg/12.5 mg/160 mg | Exforge HCT | 10/22/2009 |
| amlodipine, hydrochlorothiazide and valsartan | Tablets | 5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 m | Exforge HCT | 9/14/2009 |
| amlodipine besylate and valsartan | Tablets | 5 mg/320 mg | Exforge | 11/26/2007 |
| amlodipine besylate and valsartan | Tablets | 10 mg/320 mg | Exforge | 11/9/2007 |
| amlodipine besylate and valsartan | Tablets | 5 mg/160 mg | Exforge | 10/22/2007 |
| amlodipine besylate and valsartan | Tablets | 10 mg/160 mg | Exforge | 10/1/2007 |
Non-Orange Book Patents for Tradename: EXFORGE
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,485,745 | Solid oral dosage forms of valsartan | <disabled in preview> | |||||||||||||||||||||||||||
| 6,204,281 | Method of treatment and pharmaceutical composition | <disabled in preview> | |||||||||||||||||||||||||||
| 6,858,228 | Solid oral dosage forms of valsartan | <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 Tradename: EXFORGE
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2673462 | <disabled in preview> | |||||||||||||||||||||||||||
| Russian Federation | 2013113610 | <disabled in preview> | |||||||||||||||||||||||||||
| Poland | 330709 | <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: EXFORGE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 13/058 | Ireland | <disabled> | PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF, AND AMLODIPINE, OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/11/686/001-EU/1/11/686/056 20110414 | ||||||||||||||||||||||||||
| 12/018 | Ireland | <disabled> | PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705 | ||||||||||||||||||||||||||
| 00375 | Netherlands | <disabled> | PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819 | ||||||||||||||||||||||||||
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