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EXFORGE Drug Profile

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Exforge is a drug marketed by Novartis and is included in two NDAs. It is available from three suppliers. There are four patents protecting this drug and six Paragraph IV challenges.

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 list3
Formulation / Manufacturing:see details
Drug Prices: :see details

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;ORAL021990-002Jun 20, 2007RXNo6,395,728Jul 8, 2019Y
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-004Apr 30, 2009RXNo8,101,599May 16, 2023Y
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-005Jun 20, 2007RXYes6,395,728Jul 8, 2019Y
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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;ORAL021990-002Jun 20, 20075,399,578*PED<disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-005Jun 20, 20075,399,578*PED<disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-003Jun 20, 20075,399,578*PED<disabled>
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Paragraph IV activity for: EXFORGE

Drugname Dosage Strength RLD Submissiondate
amlodipine, hydrochlorothiazide and valsartanTablets10 mg/12.5 mg/160 mgExforge HCT10/22/2009
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 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<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
Canada2673462<disabled in preview>
Russian Federation2013113610<disabled in preview>
Poland330709<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
13/058Ireland<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
12/018Ireland<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
00375Netherlands<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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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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