ZOLPIDEM TARTRATE Drug Patent Profile
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When do Zolpidem Tartrate patents expire, and when can generic versions of Zolpidem Tartrate launch?
Zolpidem Tartrate is a drug marketed by Almatica, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Breckenridge, Lupin Ltd, Sandoz, Sun Pharm, Synthon Pharms, Acme Labs, Apotex Inc, Aurobindo Pharma, Chartwell Molecular, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Watson Labs, Wockhardt, Yung Shin Pharm, Dr Reddys, Mylan, Novel Labs Inc, Par Form, and Par Pharm Inc. and is included in thirty-six NDAs.
The generic ingredient in ZOLPIDEM TARTRATE 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 Zolpidem Tartrate
A generic version of ZOLPIDEM TARTRATE was approved as zolpidem tartrate by ACME LABS on April 23rd, 2007.
Summary for ZOLPIDEM TARTRATE
| US Patents: | 0 |
| Applicants: | 33 |
| NDAs: | 36 |
| Finished Product Suppliers / Packagers: | 42 |
| Raw Ingredient (Bulk) Api Vendors: | 18 |
| Clinical Trials: | 24 |
| Patent Applications: | 634 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ZOLPIDEM TARTRATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZOLPIDEM TARTRATE |
| What excipients (inactive ingredients) are in ZOLPIDEM TARTRATE? | ZOLPIDEM TARTRATE excipients list |
| DailyMed Link: | ZOLPIDEM TARTRATE at DailyMed |
See drug prices for ZOLPIDEM TARTRATE
Recent Clinical Trials for ZOLPIDEM TARTRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institutes of Health (NIH) | Phase 4 |
| National Institute on Aging (NIA) | Phase 4 |
| University of Pennsylvania | Phase 4 |
Pharmacology for ZOLPIDEM TARTRATE
| Drug Class | gamma-Aminobutyric Acid A Receptor Positive Modulator gamma-Aminobutyric Acid-ergic Agonist |
| Mechanism of Action | GABA A Receptor Positive Modulators GABA A Agonists |
| Physiological Effect | Central Nervous System Depression |
Anatomical Therapeutic Chemical (ATC) Classes for ZOLPIDEM TARTRATE
Paragraph IV (Patent) Challenges for ZOLPIDEM TARTRATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| INTERMEZZO | Sublingual Tablets | zolpidem tartrate | 1.75 mg and 3.5 mg | 022328 | 1 | 2012-04-10 |
| EDLUAR | Sublingual Tablets | zolpidem tartrate | 5 mg and 10 mg | 021997 | 1 | 2010-04-29 |
| 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 ZOLPIDEM TARTRATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Strides Pharma | ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET;ORAL | 078616-001 | Nov 21, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Invagen Pharms | ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET;ORAL | 078184-001 | Sep 7, 2007 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm Industries | ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET;ORAL | 077288-002 | Apr 23, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Yung Shin Pharm | ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET;ORAL | 077990-001 | Apr 23, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sun Pharm Inds Inc | ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET;ORAL | 077359-002 | Apr 23, 2007 | DISCN | No | No | ⤷ 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 |
