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TRAZODONE HYDROCHLORIDE Drug Profile
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Which patents cover Trazodone Hydrochloride, and when can generic versions of Trazodone Hydrochloride launch?
Trazodone Hydrochloride is a drug marketed by Accord Hlthcare, Alvogen, Am Therap, Apotex, Apotex Inc, Aurolife Pharma Llc, Fosun Pharma, Mylan, Mylan Pharms Inc, Oxford Pharms, Pliva, Quantum Pharmics, Sun Pharm Industries, Teva, Teva Pharms Usa, Torrent, Usl Pharma, Watson Labs, and Zydus Pharms. and is included in twenty-nine NDAs.
The generic ingredient in TRAZODONE HYDROCHLORIDE is trazodone hydrochloride. There are fourteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Trazodone Hydrochloride
A generic version of TRAZODONE HYDROCHLORIDE was approved as trazodone hydrochloride by APOTEX on March 25th, 1987.
Summary for TRAZODONE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 19 |
| NDAs: | 29 |
| Suppliers / Packagers: | 35 |
| Bulk Api Vendors: | 96 |
| Clinical Trials: | 49 |
| Patent Applications: | 1,358 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRAZODONE HYDROCHLORIDE |
| DailyMed Link: | TRAZODONE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for TRAZODONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| VA Office of Research and Development | Phase 3 |
| Erich Seifritz | Phase 2 |
| Chang Gung Memorial Hospital | Phase 4 |
Pharmacology for TRAZODONE HYDROCHLORIDE
| Drug Class | Serotonin Reuptake Inhibitor |
Medical Subject Heading (MeSH) Categories for TRAZODONE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for TRAZODONE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OLEPTRO | TABLET, EXTENDED RELEASE;ORAL | trazodone hydrochloride | 022411 | 2010-10-18 |
| DESYREL | TABLET;ORAL | trazodone hydrochloride | 018207 |
US Patents and Regulatory Information for TRAZODONE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | TRAZODONE HYDROCHLORIDE | trazodone hydrochloride | TABLET;ORAL | 070857-001 | Oct 10, 1986 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Teva | TRAZODONE HYDROCHLORIDE | trazodone hydrochloride | TABLET;ORAL | 074357-001 | Apr 30, 1997 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Zydus Pharms | TRAZODONE HYDROCHLORIDE | trazodone hydrochloride | TABLET;ORAL | 205253-001 | Oct 10, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Quantum Pharmics | TRAZODONE HYDROCHLORIDE | trazodone hydrochloride | TABLET;ORAL | 070921-001 | Dec 1, 1986 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Teva Pharms Usa | TRAZODONE HYDROCHLORIDE | trazodone hydrochloride | TABLET;ORAL | 071523-001 | Dec 11, 1987 | AB | RX | No | No | 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 |
