AMBIEN Drug Patent Profile
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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 23rd, 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 |
Formulation / Manufacturing: | see details |
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 |
Recent Clinical Trials for AMBIEN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institutes of Health (NIH) | Phase 2 |
University of Illinois at Chicago | Phase 4 |
California Pacific Medical Center Research Institute | Phase 4 |
Pharmacology for AMBIEN
Drug Class | gamma-Aminobutyric Acid-ergic Agonist |
Mechanism of Action | GABA A Agonists |
Physiological Effect | Central Nervous System Depression |
Anatomical Therapeutic Chemical (ATC) Classes for AMBIEN
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sanofi Aventis Us | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-001 | Sep 2, 2005 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sanofi Aventis Us | AMBIEN | zolpidem tartrate | TABLET;ORAL | 019908-002 | Dec 16, 1992 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | AMBIEN | zolpidem tartrate | TABLET;ORAL | 019908-002 | Dec 16, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMBIEN
See the table below for patents covering AMBIEN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 155664 | ⤷ Try a Trial | |
Mexico | 6463 | ⤷ Try a Trial | |
Denmark | 465181 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMBIEN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2236132 | 300714 | Netherlands | ⤷ Try a 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 | C300714 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718 |
2236132 | 92636 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |