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Generated: June 28, 2017
What is the patent landscape for Exforge, and when can generic versions of Exforge launch?
Exforge is a drug marketed by Novartis and is included in two NDAs. There are four patents protecting this drug and six Paragraph IV challenges.| Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 3 |
| Bulk Api Vendors: see list | 85 |
| Clinical Trials: see list | 13 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | EXFORGE at DailyMed |
| Ingredient-type | Dihydropyridines |
| Drug Class | Dihydropyridine Calcium Channel Blocker Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Calcium Channel Antagonists 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 | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | AB | RX | Yes | No | 6,395,728 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | AB | RX | Yes | No | 8,101,599 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | AB | RX | Yes | Yes | 6,395,728 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | AB | RX | Yes | No | 6,294,197*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-002 | Apr 30, 2009 | AB | RX | Yes | No | 8,101,599 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
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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 | ► Subscribe | ||||||||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | 5,399,578*PED | ► Subscribe | ||||||||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | 5,399,578*PED | ► Subscribe | ||||||||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-003 | Jun 20, 2007 | 5,399,578*PED | ► Subscribe | ||||||||||||||||||||||
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| 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 |
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 | ► Subscribe | |||||||||||||||||||||||||||
| 6,204,281 | Method of treatment and pharmaceutical composition | ► Subscribe | |||||||||||||||||||||||||||
| 6,858,228 | Solid oral dosage forms of valsartan | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Austria | 446749 | ► Subscribe | |||||||||||||||||||||||||||
| Malaysia | 123149 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 4969338 | ► Subscribe | |||||||||||||||||||||||||||
| Slovakia | 178498 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 333385 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00375 | Netherlands | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 07C/043 | Belgium | ► Subscribe | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 | ||||||||||||||||||||||||||
| 00478 | Netherlands | ► Subscribe | PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007 | ||||||||||||||||||||||||||
| 0443983/03 | Switzerland | ► Subscribe | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 | ||||||||||||||||||||||||||
| 2011 00026 | Denmark | ► Subscribe | PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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