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

Summary for AMBIEN CR

International Patents:	33
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	11
Clinical Trials:	45
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AMBIEN CR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMBIEN CR
DailyMed Link:	AMBIEN CR at DailyMed

Pharmacology for AMBIEN CR

Drug Class	gamma-Aminobutyric Acid-ergic Agonist
Mechanism of Action	GABA A Agonists
Physiological Effect	Central Nervous System Depression

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

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

Paragraph IV (Patent) Challenges for AMBIEN CR

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	6.25 mg
	Extended-release Tablets	12.5 mg

International Patents for AMBIEN CR

Country	Document Number	Estimated Expiration
Denmark	1135125
Canada	2391983
Austria	290861
Czech Republic	20011969
Turkey	200101588
European Patent Office	1135125
Norway	20012668

Supplementary Protection Certificates for AMBIEN CR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2015000006	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
00714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
0714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718