DrugPatentWatch Database Preview
AMBIEN CR Drug Profile
Email this page to a colleague
See Plans and PricingWhen 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.
Summary for AMBIEN CR
| International Patents: | 33 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 8 |
| Clinical Trials: | 47 |
| 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 |
Recent Clinical Trials for AMBIEN CR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| HealthPartners Institute | Early Phase 1 |
| US Department of Veterans Affairs | Phase 4 |
| University of California, San Francisco | Phase 4 |
Recent Litigation for AMBIEN CR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2015-09-15 |
| Purdue Pharmaceutical v. Actavis Elizabeth LLC | 2015-05-13 |
| SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC. | 2015-01-16 |
Pharmacology for AMBIEN CR
| Drug Class | gamma-Aminobutyric Acid-ergic Agonist |
| Mechanism of Action | GABA A Agonists |
| Physiological Effect | Central Nervous System Depression |
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 |
International Patents for AMBIEN CR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 4574857 | Start Trial |
| Canada | 2391983 | Start Trial |
| Taiwan | 565448 | Start Trial |
| Germany | 69924283 | Start Trial |
| Slovakia | 7612001 | Start Trial |
| Brazil | 9915939 | Start Trial |
| New Zealand | 511750 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
