AMBIEN CR Drug Patent Profile

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ambien Cr

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

Summary for AMBIEN CR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Clinical Trials:	49
Drug Prices:	Drug price information for AMBIEN CR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMBIEN CR
What excipients (inactive ingredients) are in AMBIEN CR?	AMBIEN CR excipients list
DailyMed Link:	AMBIEN CR at DailyMed

See drug prices for AMBIEN CR

See drug sales revenues for AMBIEN CR

Recent Clinical Trials for AMBIEN CR

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

Sponsor	Phase
National Institutes of Health (NIH)	Phase 2
University of Virginia	Phase 4
Patient-Centered Outcomes Research Institute	Phase 4

See all AMBIEN CR clinical trials

Pharmacology for AMBIEN CR

Drug Class	gamma-Aminobutyric Acid A Receptor Positive Modulator
Mechanism of Action	GABA A Receptor Positive Modulators
Physiological Effect	Central Nervous System Depression

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
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-001	Sep 2, 2005	AB	RX	Yes	Yes

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
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-001	Sep 2, 2005
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-001	Sep 2, 2005

International Patents for AMBIEN CR

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

Country	Patent Number	Title	Estimated Expiration
South Africa	200104169	Controlled-released dosage forms comprising zolpidem or a salt thereof.
Canada	2391983	FORMES POSOLOGIQUES A LIBERATION REGULEE CONTENANT DU ZOLPIDEM OU UN SEL DE CELUI-CI (CONTROLLED-RELEASE DOSAGE FORMS COMPRISING ZOLPIDEM OR A SALT THEREOF)
European Patent Office	0050563	IMIDAZO(1,2-A)PYRIDINE DERIVATIVES, PROCESS FOR THEIR PREPARATION AND THEIR THERAPEUTICAL USE

Supplementary Protection Certificates for AMBIEN CR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	CA 2015 00004	Denmark		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	92636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132	122015000006	Germany		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