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Generated: April 25, 2017

DrugPatentWatch Database Preview

Details for Patent: 6,514,531

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Which drugs does patent 6,514,531 protect, and when does it expire?

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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Sanofi Aventis Us
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-002Sep 2, 2005ABRXYesNo6,514,531*PED► SubscribeY
Sanofi Aventis Us
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-001Sep 2, 2005ABRXYesYes6,514,531*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
Slovenia1135125► Subscribe
Portugal1135125► Subscribe
Poland198396► Subscribe
Poland348782► Subscribe
New Zealand511750► 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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