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Details for Patent: 6,495,165

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Patent 6,495,165 protects INSPRA and is included in one NDA. There has been one Paragraph IV challenge on Inspra.

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

This patent has twenty-nine patent family members in twenty-seven countries.

Summary for Patent: 6,495,165

Title: Eplerenone compositions having improved bioavailability
Abstract:The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
Inventor(s): Thosar; Shilpa S. (Des Plaines, IL), Gokhale; Rajeev D. (Waukegan, IL), Tolbert; Dwain S. (Wadsworth, IL)
Assignee: G.D. Searle & Co. (Skokie, IL)
Application Number:10/101,361
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 18th 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
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-001Sep 27, 2002RXNo6,495,165*PED► subscribeY
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-002Sep 27, 2002RXYes6,495,165*PED► subscribeY
Gd Searle Llc
INSPRA
eplerenone
TABLET;ORAL021437-003Sep 27, 2002DISCNNo6,495,165*PED► subscribeY
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Non-Orange Book Patents for Patent: 6,495,165

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
7,157,101Micronized eplerenone compositions► subscribe
6,534,093 Immediate release eplerenone compositions► subscribe
6,558,707 Immediate release eplerenone compositions► 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: 6,495,165

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina028982► subscribe
Austria249223► subscribe
Australia1936800► 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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