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Generated: June 29, 2017
What is the patent landscape for Ambien Cr, 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.| Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 10 |
| Clinical Trials: see list | 29 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | AMBIEN CR at DailyMed |
| Ingredient-type | Pyridines |
| Drug Class | gamma-Aminobutyric Acid-ergic Agonist |
| Mechanism of Action | GABA A Agonists |
| Physiological Effect | Central Nervous System Depression |
| 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 | 6,514,531*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-001 | Sep 2, 2005 | AB | RX | Yes | Yes | 6,514,531*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
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| 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 | 4,382,938*PED | ► Subscribe | ||||||||||||||||||||||
Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-001 | Sep 2, 2005 | 4,382,938*PED | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| zolpidem tartrate | Extended-release Tablets | 6.25 mg | Ambien CR | 2/24/2006 |
| zolpidem tartrate | Extended-release Tablets | 12.5 mg | Ambien CR | 1/19/2006 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2002531499 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 1135125 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2539900 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 4574857 | ► Subscribe | |||||||||||||||||||||||||||
| Turkey | 200101588 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015 00004 | Denmark | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 636 | Luxembourg | ► Subscribe | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES | ||||||||||||||||||||||||||
| 00714 | Netherlands | ► Subscribe | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718 | ||||||||||||||||||||||||||
| 2015000006 | Germany | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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