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Serving leading biopharmaceutical companies globally:

Queensland Health
Harvard Business School
Cantor Fitzgerald
Express Scripts
McKesson
US Department of Justice
Covington
Teva
Chubb
Farmers Insurance

Generated: December 12, 2017

DrugPatentWatch Database Preview

EXFORGE Drug Profile

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When do Exforge patents expire, 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.

This drug has eighty-seven patent family members in thirty-three countries and sixteen supplementary protection certificates in eight countries.

The generic ingredient in EXFORGE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
NovartisEXFORGEamlodipine besylate; valsartanTABLET;ORAL021990-002Jun 20, 2007ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-004Apr 30, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisEXFORGEamlodipine besylate; valsartanTABLET;ORAL021990-005Jun 20, 2007ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisEXFORGEamlodipine besylate; valsartanTABLET;ORAL021990-004Jun 20, 2007ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-002Apr 30, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-004Apr 30, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisEXFORGEamlodipine besylate; valsartanTABLET;ORAL021990-005Jun 20, 2007ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-004Apr 30, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-003Apr 30, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisEXFORGE HCTamlodipine besylate; hydrochlorothiazide; valsartanTABLET;ORAL022314-002Apr 30, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: EXFORGE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
NovartisEXFORGEamlodipine besylate; valsartanTABLET;ORAL021990-005Jun 20, 2007► Subscribe► Subscribe
NovartisEXFORGEamlodipine besylate; valsartanTABLET;ORAL021990-002Jun 20, 2007► Subscribe► Subscribe
NovartisEXFORGEamlodipine besylate; valsartanTABLET;ORAL021990-003Jun 20, 2007► Subscribe► Subscribe
NovartisEXFORGEamlodipine besylate; valsartanTABLET;ORAL021990-004Jun 20, 2007► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for EXFORGE

Drugname Dosage Strength RLD Submissiondate
amlodipine, hydrochlorothiazide and valsartanTablets5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mExforge HCT9/14/2009
amlodipine, hydrochlorothiazide and valsartanTablets10 mg/12.5 mg/160 mgExforge HCT10/22/2009
amlodipine besylate and valsartanTablets5 mg/320 mgExforge11/26/2007
amlodipine besylate and valsartanTablets10 mg/320 mgExforge11/9/2007
amlodipine besylate and valsartanTablets5 mg/160 mgExforge10/22/2007
amlodipine besylate and valsartanTablets10 mg/160 mgExforge10/1/2007

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► 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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International Patent Family for Tradename: EXFORGE

Country Document Number Estimated Expiration
Slovakia178498► Subscribe
Australia3340297► Subscribe
Germany69730834► Subscribe
Spain2335683► Subscribe
Norway986056► Subscribe
Israel195339► Subscribe
European Patent Office1410797► Subscribe
Argentina059324► Subscribe
Slovenia914119► Subscribe
New Zealand524346► 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 Certificates for Tradename: EXFORGE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00486Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
00625Netherlands► SubscribePRODUCT 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
07C/043Belgium► SubscribePRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
00528Netherlands► SubscribePRODUCT 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
00499Netherlands► SubscribePRODUCT 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
0625Netherlands► SubscribePRODUCT 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
00445Netherlands► SubscribePRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
12/018Ireland► SubscribePRODUCT 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
00478Netherlands► SubscribePRODUCT 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
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
US Army
Moodys
Cerilliant
US Department of Justice
Covington
Fish and Richardson
Chinese Patent Office
Daiichi Sankyo

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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