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Last Updated: October 15, 2019

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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. Fifty-four suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Drug patent expirations by year for AMBIEN CR
Drug Prices for AMBIEN CR

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Drug Sales Revenue Trends for AMBIEN CR

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Recent Clinical Trials for AMBIEN CR

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SponsorPhase
HealthPartners InstituteEarly Phase 1
University of California, San FranciscoPhase 4
US Department of Veterans AffairsPhase 4

See all AMBIEN CR clinical trials

Recent Litigation for AMBIEN CR

Identify potential future generic entrants

District Court Litigation
Case NameDate
Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-15
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13
SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC.2015-01-16

See all AMBIEN CR litigation

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

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   See Pricing   See Pricing
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for AMBIEN CR
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 6.25 mg ➤ Subscribe   See Pricing
➤ Subscribe Extended-release Tablets 12.5 mg ➤ Subscribe   See Pricing

Supplementary Protection Certificates for AMBIEN CR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 92636 Luxembourg   See Pricing PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132 122015000006 Germany   See Pricing 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
2236132 CA 2015 00004 Denmark   See Pricing 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
2236132 C300714 Netherlands   See Pricing PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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