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AVAPRO Drug Profile

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Avapro is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from six suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in twenty-four countries.

The generic ingredient in AVAPRO is irbesartan. There are thirty-eight drug master file entries for this compound. Thirty suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the irbesartan profile page.

Summary for Tradename: AVAPRO

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list6

Pharmacology for Tradename: AVAPRO

Clinical Trials for: AVAPRO

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-001Sep 30, 1997RXNo6,342,247*PED<disabled> <disabled>
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-002Sep 30, 1997RXNo6,342,247*PED<disabled> <disabled>
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-003Sep 30, 1997RXYes6,342,247*PED<disabled> <disabled>
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Expired Patents for Tradename: AVAPRO

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-002Sep 30, 19976,342,247*PED<disabled>
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-001Sep 30, 19975,270,317*PED<disabled>
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-002Sep 30, 19975,270,317*PED<disabled>
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Paragraph IV activity for: AVAPRO

Drugname Dosage Strength RLD Submissiondate
irbesartanTablets75 mg, 150 mg and 300 mgAvapro5/25/2004

Non-Orange Book Patents for Tradename: AVAPRO

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
5,994,348 Pharmaceutical compositions containing irbesartan<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: AVAPRO

Country Document Number Estimated Expiration
Poland314670<disabled in preview>
European Patent Office0747050<disabled in preview>
Canada2177772<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: AVAPRO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90006Netherlands<disabled>PRODUCT NAME: IRBESARTAN, DESGEWENST IN DE VORM VAN EEN ZOUT EN/OF EEN HYDRAAT, EN HYDROCHLOORTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 - EU/1/98/086/006 19981015
/1998Austria<disabled>PRODUCT NAME: ''IRBESARTAN'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE; NAT. REGISTRATION NO/DATE: EU/1/97/046/001 - EU/1/97/046/009 19970827; FIRST REGISTRATION: LI 5425002 19970815
C/GB99/008United Kingdom<disabled>PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
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