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 Cosette 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-three 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.
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Questions you can ask:
- What is the 5 year forecast for AMBIEN?
- What are the global sales for AMBIEN?
- What is Average Wholesale Price for AMBIEN?
Summary for AMBIEN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 49 |
| Patent Applications: | 4,514 |
| 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 |
| California Pacific Medical Center Research Institute | Phase 4 |
| University of Arizona | Phase 4 |
Pharmacology for AMBIEN
| Drug Class | gamma-Aminobutyric Acid A Receptor Positive Modulator |
| Mechanism of Action | GABA A Receptor Positive Modulators |
| Physiological Effect | Central Nervous System Depression |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cosette | AMBIEN | zolpidem tartrate | TABLET;ORAL | 019908-001 | Dec 16, 1992 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Cosette | AMBIEN CR | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774-001 | Sep 2, 2005 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Cosette | AMBIEN | zolpidem tartrate | TABLET;ORAL | 019908-002 | Dec 16, 1992 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for AMBIEN
See the table below for patents covering AMBIEN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 7393 | ⤷ Start Trial | |
| Australia | 544345 | ⤷ Start Trial | |
| Australia | 7668781 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMBIEN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 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 | 92636 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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