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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
McKinsey
Colorcon
Novartis
Merck
Cantor Fitzgerald
QuintilesIMS
Mallinckrodt
Dow
Boehringer Ingelheim

Generated: January 16, 2018

DrugPatentWatch Database Preview

AMBIEN CR Drug Profile

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

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

This drug has thirty-three patent family members in twenty-seven countries and five supplementary protection certificates in four 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 AMBIEN CR
Drug patent expirations by year for AMBIEN CR
Pharmacology for AMBIEN CR

US Patents and Regulatory Information for AMBIEN CR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-002 Sep 2, 2005 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for AMBIEN CR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-002 Sep 2, 2005 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for AMBIEN CR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 6.25 mg ➤ Subscribe 2/24/2006
➤ Subscribe Extended-release Tablets 12.5 mg ➤ Subscribe 1/19/2006

International Patents for AMBIEN CR

Supplementary Protection Certificates for AMBIEN CR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
636 Luxembourg ➤ Subscribe PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
0714 Netherlands ➤ Subscribe PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2015 00004 Denmark ➤ Subscribe PRODUCT 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
2015000006 Germany ➤ Subscribe PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
00714 Netherlands ➤ Subscribe PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Healthtrust
Argus Health
Farmers Insurance
Julphar
US Department of Justice
Cantor Fitzgerald
Citi
Medtronic
Daiichi Sankyo

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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