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Last Updated: May 20, 2022

AMBIEN CR Drug Patent 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.

The generic ingredient in AMBIEN CR is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-seven 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
California Pacific Medical Center Research InstitutePhase 4
University of ArizonaPhase 4
University of VirginiaPhase 4

See all AMBIEN CR clinical trials

Pharmacology for AMBIEN CR
Anatomical Therapeutic Chemical (ATC) Classes for AMBIEN CR
Paragraph IV (Patent) Challenges for AMBIEN CR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AMBIEN CR Extended-release Tablets zolpidem tartrate 6.25 mg 021774 1 2006-02-24
AMBIEN CR Extended-release Tablets zolpidem tartrate 12.5 mg 021774 1 2006-01-19

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 Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and 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 021774-001 Sep 2, 2005 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-002 Sep 2, 2005 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-002 Sep 2, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AMBIEN CR

See the table below for patents covering AMBIEN CR around the world.

Country Patent Number Title Estimated Expiration
African Intellectual Property Organization (OAPI) 7076 See Plans and Pricing
China 1212838 See Plans and Pricing
Israel 143146 CONTROLLED-RELEASE DOSAGE FORMS COMPRISING ZOLPIDEM OR A SALT THEREOF See Plans and Pricing
Israel 64091 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AMBIEN CR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 122015000006 Germany See Plans and 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 Plans and 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 300714 Netherlands See Plans and Pricing PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132 92636 Luxembourg See Plans and Pricing PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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