Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Johnson and Johnson
Medtronic
Baxter
Merck

Last Updated: February 20, 2020

DrugPatentWatch Database Preview

AMBIEN CR Drug Profile


Email this page to a colleague

See Plans and Pricing

« Back to Dashboard

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

US ANDA Litigation and Generic Entry Outlook for Ambien Cr

A generic version of AMBIEN CR was approved as zolpidem tartrate by ACME LABS on April 23rd, 2007.

  Start Trial

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

See drug prices for AMBIEN CR

Drug Sales Revenue Trends for AMBIEN CR

See drug sales revenues for AMBIEN CR

Recent Clinical Trials for AMBIEN CR

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

SponsorPhase
HealthPartners InstituteEarly Phase 1
US Department of Veterans AffairsPhase 4
University of California, San FranciscoPhase 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
Paragraph IV (Patent) Challenges for AMBIEN CR
Tradename Dosage Ingredient NDA Submissiondate
AMBIEN CR TABLET, EXTENDED RELEASE;ORAL zolpidem tartrate 021774 2006-02-24
AMBIEN CR TABLET, EXTENDED RELEASE;ORAL zolpidem tartrate 021774 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   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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   Start Trial   Start Trial
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for AMBIEN CR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 300714 Netherlands   Start Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132 CA 2015 00004 Denmark   Start 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
2236132 122015000006 Germany   Start Trial 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 C300714 Netherlands   Start Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132 92636 Luxembourg   Start Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Express Scripts
Johnson and Johnson
McKesson
Moodys
Baxter

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.