TEMAZEPAM Drug Patent Profile
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Which patents cover Temazepam, and what generic alternatives are available?
Temazepam is a drug marketed by Actavis Elizabeth, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Usa, Chartwell Rx, Duramed Pharms Barr, Novel Labs Inc, Prinston Inc, Sun Pharm Industries, Usl Pharma, and Watson Labs. and is included in twenty-one NDAs.
The generic ingredient in TEMAZEPAM is temazepam. There are seven drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the temazepam profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Temazepam
A generic version of TEMAZEPAM was approved as temazepam by NOVEL LABS INC on April 21st, 1987.
Summary for TEMAZEPAM
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 21 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 34 |
| Clinical Trials: | 9 |
| Patent Applications: | 4,109 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TEMAZEPAM |
| Drug Sales Revenues: | Drug sales revenues for TEMAZEPAM |
| What excipients (inactive ingredients) are in TEMAZEPAM? | TEMAZEPAM excipients list |
| DailyMed Link: | TEMAZEPAM at DailyMed |
Recent Clinical Trials for TEMAZEPAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Turku University Hospital | Phase 4 |
| Saint-Joseph University | Phase 3 |
| Hannover Medical School | Phase 3 |
Pharmacology for TEMAZEPAM
| Drug Class | Benzodiazepine |
Medical Subject Heading (MeSH) Categories for TEMAZEPAM
Anatomical Therapeutic Chemical (ATC) Classes for TEMAZEPAM
US Patents and Regulatory Information for TEMAZEPAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Industries | TEMAZEPAM | temazepam | CAPSULE;ORAL | 071174-001 | Jul 10, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Prinston Inc | TEMAZEPAM | temazepam | CAPSULE;ORAL | 201781-002 | Jun 4, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm Industries | TEMAZEPAM | temazepam | CAPSULE;ORAL | 071175-002 | Sep 14, 2009 | 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 |
