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Details for Patent: 5,994,348

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Patent 5,994,348 protects AVALIDE and is included in one NDA. There have been two Paragraph IV challenges on Avalide. There are three tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

Protection for AVALIDE has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

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

Summary for Patent: 5,994,348

Title: Pharmaceutical compositions containing irbesartan
Abstract:Pharmaceutical compositions containing irbesartan, alone or in combination with a diuretic, providing tablets with a high relative amount of active agent and excellent wetting and disintegration properties.
Inventor(s): Ku; Cathy C. (Martinsville, NJ), Sprockel; Omar L. (Bridgewater, NJ), Lang; Beth A. (Bedminster, NJ), Desai; Divyakant S. (Robbinsville, NJ)
Assignee: Sanofi (Paris, FR)
Application Number:09/081,685
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 35th percentile
Forward Citations: 3rd percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-001Sep 30, 1997DISCNNo5,994,348*PED► subscribe
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-002Sep 30, 1997RXYes5,994,348*PED► subscribe
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-003Aug 31, 1998RXYes5,994,348*PED► subscribe
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Non-Orange Book Patents for Patent: 5,994,348

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
6,342,247 Pharmaceutical compositions containing irbesartan► subscribe
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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 Patent: 5,994,348

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina002350► subscribe
Argentina054782► subscribe
Austria248594► subscribe
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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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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.

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