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Serving leading biopharmaceutical companies globally:

Accenture
Harvard Business School
Healthtrust
Novartis
Teva
UBS
Chinese Patent Office
Dow
Farmers Insurance
Deloitte

Generated: December 11, 2017

DrugPatentWatch Database Preview

AMBIEN Drug Profile

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When do Ambien patents expire, and when can generic versions of Ambien launch?

Ambien is a drug marketed by Sanofi Aventis Us and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

The generic ingredient in AMBIEN is zolpidem tartrate. There are thirty-one drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis UsAMBIENzolpidem tartrateTABLET;ORAL019908-001Dec 16, 1992ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsAMBIEN CRzolpidem tartrateTABLET, EXTENDED RELEASE;ORAL021774-001Sep 2, 2005ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sanofi Aventis UsAMBIENzolpidem tartrateTABLET;ORAL019908-002Dec 16, 1992ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsAMBIEN CRzolpidem tartrateTABLET, EXTENDED RELEASE;ORAL021774-002Sep 2, 2005ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for AMBIEN

Drugname Dosage Strength RLD Submissiondate
zolpidem tartrateExtended-release Tablets6.25 mgAmbien CR2/24/2006
zolpidem tartrateExtended-release Tablets12.5 mgAmbien CR1/19/2006

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Citi
Chinese Patent Office
Cerilliant
McKinsey
Queensland Health
Novartis
Federal Trade Commission
Mallinckrodt
Colorcon

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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