AMBIEN Drug Patent Profile

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 23^rd, 2007.

Summary for AMBIEN

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	49
Drug Prices:	Drug price information for AMBIEN
Drug Sales Revenues:	Drug sales revenues for AMBIEN
What excipients (inactive ingredients) are in AMBIEN?	AMBIEN excipients list
DailyMed Link:	AMBIEN at DailyMed

See drug prices for AMBIEN

See drug sales revenues for AMBIEN

Recent Clinical Trials for AMBIEN

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

Sponsor	Phase
National Institutes of Health (NIH)	Phase 2
University of Arizona	Phase 4
University of Virginia	Phase 4

See all AMBIEN clinical trials

Pharmacology for AMBIEN

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

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
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-001	Sep 2, 2005	AB	RX	Yes	Yes
Sanofi Aventis Us	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908-002	Dec 16, 1992	AB	RX	Yes	Yes
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-002	Sep 2, 2005	AB	RX	Yes	No

Expired US Patents for AMBIEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908-001	Dec 16, 1992
Sanofi Aventis Us	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908-002	Dec 16, 1992

International Patents for AMBIEN

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

Country	Patent Number	Title	Estimated Expiration
Japan	S637545
Finland	71143
South Africa	8107297
Austria	7393
Israel	64091
Finland	813288
New Zealand	198722	N-SUBSTITUTED-2-(PHENYL OR NAPHTHYL)IMIDAZO(1,2-A)-PYRID-3-YLACETAMIDES

Supplementary Protection Certificates for AMBIEN

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