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EXFORGE HCT Drug Profile

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

This drug has one hundred and fourteen patent family members in thirty-six countries.

The generic ingredient in EXFORGE HCT 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 HCT

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Formulation / Manufacturing:see details

Clinical Trials for: EXFORGE HCT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-001Apr 30, 2009RXNo8,101,599<disabled>Y <disabled>
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-003Apr 30, 2009RXNo8,101,599<disabled>Y <disabled>
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-002Apr 30, 2009RXNo8,101,599<disabled>Y <disabled>
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Expired Patents for Tradename: EXFORGE HCT

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-001Apr 30, 20095,399,578*PED<disabled>
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-004Apr 30, 20095,399,578*PED<disabled>
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-005Apr 30, 20095,399,578*PED<disabled>
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Paragraph IV activity for: EXFORGE HCT

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

Non-Orange Book Patents for Tradename: EXFORGE HCT

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>
6,858,228 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 HCT

Country Document Number Estimated Expiration
Japan2005533023<disabled in preview>
South Korea20110107877<disabled in preview>
European Patent Office1776953<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 HCT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0443983/03Switzerland<disabled>PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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
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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