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Details for Patent: 6,514,531

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Patent 6,514,531 protects AMBIEN CR and is included in one NDA. There have been two Paragraph IV challenges on Ambien CR.

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

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

Summary for Patent: 6,514,531

Title: Controlled-release dosage forms comprising zolpidem or a salt thereof
Abstract:The present invention relates to controlled-release dosage forms of zolpidem or salts thereof adapted to release zolpidem over a predetermined time period, according to a biphasic profile of dissolution, where the first phase is an immediate release phase and the second phase is a prolonged release phase and particular embodiments thereof intended to avoid abuse.
Inventor(s): Alaux; Gerard (Beynes, FR), Lewis; Gareth (Dourdan, FR), Andre; Frederic (Antony, FR)
Assignee: Sanofi-Synthelabo (Paris, FR)
Application Number:09/857,154
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Device; Composition;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Sanofi Aventis Us
AMBIEN CR
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-002Sep 2, 2005RXNo6,514,531*PED► subscribeY
Sanofi Aventis Us
AMBIEN CR
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-001Sep 2, 2005RXYes6,514,531*PED► subscribeY
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Foreign Priority and PCT Information for Patent: 6,514,531

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
98403037Dec 04, 1998
PCT Information
PCT FiledDecember 01, 1999PCT Application Number:PCT/EP99/10454
PCT Publication Date:June 15, 2000PCT Publication Number: WO00/33835

International Patent Family for Patent: 6,514,531

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina021535► subscribe
Austria290861► subscribe
Australia2539900► 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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