DrugPatentWatch Database Preview
AMBIEN CR Drug 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. 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-three 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: | 44 |
| 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 | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | ||
| Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-001 | Sep 2, 2005 | AB | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free 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 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-001 | Sep 2, 2005 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for AMBIEN CR
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Tablets | 6.25 mg | ➤ Subscribe | ➤ Try a Free Trial |
| ➤ Subscribe | Extended-release Tablets | 12.5 mg | ➤ Subscribe | ➤ Try a Free Trial |
International Patents for AMBIEN CR
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1037319 | ➤ Try a Free Trial |
| Slovenia | 1135125 | ➤ Try a Free Trial |
| European Patent Office | 1135125 | ➤ Try a Free Trial |
| Japan | 2010070572 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for AMBIEN CR
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00714 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718 |
| 0714 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718 |
| 636 | Luxembourg | ➤ Try a Free Trial | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
| 2015 00004 | Denmark | ➤ Try a Free 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
