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Generated: July 22, 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 | 021990-003 | Jun 20, 2007 | 5,399,578*PED | ► Subscribe | ||||||||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | 5,399,578*PED | ► Subscribe | ||||||||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | 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 | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hong Kong | 1019858 | ► Subscribe | |||||||||||||||||||||||||||
| Poland | 330709 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 446749 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 0914119 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2673462 | ► 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 | ||||||||||||||||||||||||||
| 00528 | Netherlands | ► Subscribe | PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705 | ||||||||||||||||||||||||||
| 07C/043 | Belgium | ► Subscribe | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 | ||||||||||||||||||||||||||
| 0443983/03 | Switzerland | ► Subscribe | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 | ||||||||||||||||||||||||||
| 315 | Luxembourg | ► Subscribe | PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE | ||||||||||||||||||||||||||
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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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