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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Covington
Argus Health
Moodys
Farmers Insurance
Cerilliant
Healthtrust
Boehringer Ingelheim
Mallinckrodt

Generated: December 11, 2018

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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.

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

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
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 Date
➤ Subscribe Extended-release Tablets 6.25 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Tablets 12.5 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for AMBIEN CR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00714 Netherlands ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
0714 Netherlands ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
636 Luxembourg ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2015 00004 Denmark ➤ Try a Free Trial 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Baxter
Federal Trade Commission
US Army
Julphar
AstraZeneca
UBS
Covington

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