.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

AVAPRO Drug Profile

« Back to Dashboard
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. Twenty-nine 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
Drug Prices: :see details

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*PEDDec 7, 2015
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-002Sep 30, 1997RXNo6,342,247*PEDDec 7, 2015
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-003Sep 30, 1997RXYes6,342,247*PEDDec 7, 2015
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Tradename: AVAPRO

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

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;ORAL020757-002Sep 30, 19976,342,247*PED<disabled>
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-002Sep 30, 19975,270,317*PED<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: AVAPRO

Country Document Number Estimated Expiration
Canada2177772<disabled in preview>
Israel118309<disabled in preview>
Czech Republic291532<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

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
C0009Belgium<disabled>PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc