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Irbesartan - Generic Drug Details

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Irbesartan is the generic ingredient in two branded drugs marketed by Roxane, Cipla Ltd, Hetero Labs Ltd V, Zydus Pharms Usa Inc, Unichem Labs Ltd, Watson Labs Inc, Lupin Ltd, Apotex Inc, Jubilant Generics, Alembic Pharms Ltd, Macleods Pharms Ltd, Sanofi Aventis Us, Teva Pharms, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz, Prinston Inc, Sciegen Pharms Inc, Aurobindo Pharma Ltd, Ajanta Pharma Ltd, and Hisun Pharm Hangzhou, and is included in twenty-one NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are thirty-eight drug master file entries for irbesartan. Thirty suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: irbesartan

Tradenames:2
Patents:1
Applicants:21
NDAs:21
Drug Master File Entries: see list38
Suppliers / Packaging: see list30
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: irbesartan

Tentative approvals for IRBESARTAN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL150MG; 12.5MG
<disabled><disabled>TABLET; ORAL300MG; 12.5MG
<disabled><disabled>TABLET; ORAL300MG; 25MG

Clinical Trials for: irbesartan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant Generics
IRBESARTAN
irbesartan
TABLET;ORAL203534-003Feb 23, 2015RXNo<disabled><disabled>
Sandoz
IRBESARTAN
irbesartan
TABLET;ORAL077466-003Sep 27, 2012RXNo<disabled><disabled>
Alembic Pharms Ltd
IRBESARTAN
irbesartan
TABLET;ORAL091236-001Oct 15, 2012RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: irbesartan

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-001Sep 30, 19975,270,317*PED<disabled>
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-003Sep 30, 19975,270,317*PED<disabled>
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-002Sep 30, 19975,270,317*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: irbesartan

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 Ingredient: irbesartan

Country Document Number Estimated Expiration
Australia5476396<disabled in preview>
Poland184893<disabled in preview>
Austria503478<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: IRBESARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009Belgium<disabled>PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
80039Netherlands<disabled>PRODUCT NAME: IRBESARTAN, DESGEWENST IN DE VORM VAN EEN ZOUT EN/OF EEN HYDRAA T; REGISTRATION NO/DATE: EU/1/97/046/001 - 009 19970827
C/GB98/037United 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.; REGISTERED: CH 54 250.02 19970815; UK EU/1/97/046/001 19970827; UK EU/1/97/046/002 19970827; UK EU/1/97/046/003 19970827; UK EU/1/97/046/004 19970827; UK EU/1/97/046/005 19970827; UK EU/1/97/046/006 19970827; UK EU/1/97/046/007 19970827; UK EU/1/97/046/008 19970827; UK EU/1/97/046/009 19970827
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