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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

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, 2007RXNo6,395,728<disabled>Y <disabled>
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-004Apr 30, 2009RXNo8,101,599<disabled>Y <disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-005Jun 20, 2007RXYes6,395,728<disabled>Y <disabled>
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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;ORAL021990-003Jun 20, 20075,399,578*PED<disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-004Jun 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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International Patent Family for Tradename: EXFORGE

Country Document Number Estimated Expiration
Colombia4870755<disabled in preview>
Israel127564<disabled in preview>
European Patent Office1767206<disabled in preview>
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Supplementary Protection Certificates for Tradename: EXFORGE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00528Netherlands<disabled>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
00499Netherlands<disabled>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
C0033France<disabled>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
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