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Last Updated: August 15, 2020

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TRAZODONE HYDROCHLORIDE Drug Profile

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When do Trazodone Hydrochloride patents expire, and what generic alternatives are available?

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.

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Drug patent expirations by year for TRAZODONE HYDROCHLORIDE
Recent Clinical Trials for TRAZODONE HYDROCHLORIDE

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SponsorPhase
VA Office of Research and DevelopmentPhase 3
Erich SeifritzPhase 2
Chang Gung Memorial HospitalPhase 4

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Pharmacology for TRAZODONE HYDROCHLORIDE
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
Sun Pharm Industries TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 073137-002 Mar 24, 1993 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 206923-001 Sep 8, 2017 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

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