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Last Updated: March 29, 2024

AMBIEN Drug Patent Profile


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When do Ambien patents expire, and what generic alternatives are available?

Ambien is a drug marketed by Sanofi Aventis Us and is included in two NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Ambien

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

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Drug patent expirations by year for AMBIEN
Drug Prices for AMBIEN

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Drug Sales Revenue Trends for AMBIEN

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Recent Clinical Trials for AMBIEN

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

SponsorPhase
National Institutes of Health (NIH)Phase 2
California Pacific Medical Center Research InstitutePhase 4
University of ArizonaPhase 4

See all AMBIEN clinical trials

Pharmacology for AMBIEN
Anatomical Therapeutic Chemical (ATC) Classes for AMBIEN

US Patents and Regulatory Information for AMBIEN

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 zolpidem tartrate TABLET;ORAL 019908-001 Dec 16, 1992 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AMBIEN zolpidem tartrate TABLET;ORAL 019908-002 Dec 16, 1992 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-002 Sep 2, 2005 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for AMBIEN

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

Country Patent Number Title Estimated Expiration
African Intellectual Property Organization (OAPI) 7076 ⤷  Try a Trial
Ireland 51686 IMIDAZO(1,2-A)PYRIDINE DERIVATIVES USEFUL IN THERAPY AND THEIR PREPARATION ⤷  Try a Trial
Netherlands 930044 ⤷  Try a Trial
Spain 506412 ⤷  Try a Trial
European Patent Office 0050563 IMIDAZO(1,2-A)PYRIDINE DERIVATIVES, PROCESS FOR THEIR PREPARATION AND THEIR THERAPEUTICAL USE ⤷  Try a Trial
Japan S637545 ⤷  Try a Trial
Austria 7393 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AMBIEN

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

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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 verification 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.