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AMBIEN CR Drug Profile

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Ambien Cr is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from twelve suppliers. There is one patent protecting this drug and two Paragraph IV challenges.

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

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

Summary for Tradename: AMBIEN CR

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list12
Drug Prices: :see details

Pharmacology for Tradename: AMBIEN CR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
AMBIEN CR
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-002Sep 2, 2005RXNo6,514,531*PED► subscribeY► subscribe
Sanofi Aventis Us
AMBIEN CR
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-001Sep 2, 2005RXYes6,514,531*PED► subscribeY► subscribe
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Expired Patents for Tradename: AMBIEN CR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AMBIEN CR
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-002Sep 2, 20054,382,938*PED► subscribe
Sanofi Aventis Us
AMBIEN CR
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-001Sep 2, 20054,382,938*PED► subscribe
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Paragraph IV activity for: AMBIEN CR

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

International Patent Family for Tradename: AMBIEN CR

Country Document Number Estimated Expiration
South Korea20100130647► subscribe
Germany69924283► subscribe
Australia771902► 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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Supplementary Protection Certificates for Tradename: AMBIEN CR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00004Denmark► subscribePRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
636Luxembourg► subscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
00714Netherlands► subscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
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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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