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Generated: October 20, 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.| US 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 |
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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 | ► Subscribe | ► Subscribe | ||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | ► Subscribe | ► Subscribe | ||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | ► Subscribe | ► Subscribe | ||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | ► Subscribe | ► 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Korea | 100618038 | ► Subscribe | |||||||||||||
| Portugal | 914119 | ► Subscribe | |||||||||||||
| Slovakia | 178498 | ► Subscribe | |||||||||||||
| Turkey | 9802698 | ► Subscribe | |||||||||||||
| Russian Federation | 2294743 | ► Subscribe | |||||||||||||
| Norway | 20041287 | ► Subscribe | |||||||||||||
| European Patent Office | 0914119 | ► Subscribe | |||||||||||||
| China | 1475207 | ► Subscribe | |||||||||||||
| Japan | 2012051948 | ► Subscribe | |||||||||||||
| United Kingdom | 9613470 | ► 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.
Export unavailable in trial.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0033 | France | ► Subscribe | PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705 | ||||||||||||
| 00499 | Netherlands | ► Subscribe | PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114 | ||||||||||||
| 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 | ||||||||||||
| 315 | Luxembourg | ► Subscribe | PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE | ||||||||||||
| 00445 | Netherlands | ► Subscribe | PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016 | ||||||||||||
| 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 | ||||||||||||
| 00625 | Netherlands | ► Subscribe | PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414 | ||||||||||||
| 12/018 | Ireland | ► Subscribe | 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 | ||||||||||||
| C/GB11/010 | United Kingdom | ► Subscribe | PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK | ||||||||||||
| 07C/043 | Belgium | ► Subscribe | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 | ||||||||||||
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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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