AMBIEN CR Drug Patent 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.
The generic ingredient in AMBIEN CR is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-seven 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 23rd, 2007.
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Questions you can ask:
- What is the 5 year forecast for AMBIEN CR?
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Summary for AMBIEN CR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 4 |
| Clinical Trials: | 49 |
| 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 |
| What excipients (inactive ingredients) are in AMBIEN CR? | AMBIEN CR excipients list |
| DailyMed Link: | AMBIEN CR at DailyMed |
Recent Clinical Trials for AMBIEN CR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institutes of Health (NIH) | Phase 2 |
| Patient-Centered Outcomes Research Institute | Phase 4 |
| University of Illinois at Chicago | Phase 4 |
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 | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-001 | Sep 2, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-001 | Sep 2, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-001 | Sep 2, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-002 | Sep 2, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMBIEN CR
See the table below for patents covering AMBIEN CR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 1005863 | ⤷ Sign Up | |
| Australia | 544345 | ⤷ Sign Up | |
| African Intellectual Property Organization (OAPI) | 7076 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 0033835 | ⤷ Sign Up | |
| New Zealand | 198722 | N-SUBSTITUTED-2-(PHENYL OR NAPHTHYL)IMIDAZO(1,2-A)-PYRID-3-YLACETAMIDES | ⤷ Sign Up |
| Portugal | 1135125 | ⤷ Sign Up | |
| Spain | 506412 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMBIEN CR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2236132 | CA 2015 00004 | Denmark | ⤷ Sign Up | 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 | 300714 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718 |
| 2236132 | C300714 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718 |
| 2236132 | 122015000006 | Germany | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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