TRAZODONE HYDROCHLORIDE Drug Patent Profile

Which patents cover Trazodone Hydrochloride, and when can generic versions of Trazodone Hydrochloride launch?

Trazodone Hydrochloride is a drug marketed by Accord Hlthcare, Aiping Pharm Inc, Alvogen, Am Therap, Apotex, Apotex Inc, Aurobindo Pharma, Crossmedika Sa, Granules, Graviti Pharms, Natco, Oxford Pharms, Pharmobedient, Pliva, Quantum Pharmics, Rising, Sun Pharm Industries, Teva, Teva Pharms Usa, Torrent, Usl Pharma, Watson Labs, and Zydus Pharms. and is included in thirty-two NDAs.

The generic ingredient in TRAZODONE HYDROCHLORIDE is trazodone hydrochloride. There is one drug master file entry for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Trazodone Hydrochloride

A generic version of TRAZODONE HYDROCHLORIDE was approved as trazodone hydrochloride by APOTEX on March 25^th, 1987.

Summary for TRAZODONE HYDROCHLORIDE

US Patents:	0
Applicants:	23
NDAs:	32
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	78
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	PHASE4
University of Utah	PHASE4
Massachusetts General Hospital	PHASE4

See all TRAZODONE HYDROCHLORIDE clinical trials

Pharmacology for TRAZODONE HYDROCHLORIDE

Drug Class

Serotonin Reuptake Inhibitor

Medical Subject Heading (MeSH) Categories for TRAZODONE HYDROCHLORIDE

Anti-Anxiety Agents

Antidepressive Agents, Second-Generation

Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TRAZODONE HYDROCHLORIDE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for TRAZODONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DESYREL	Tablets	trazodone hydrochloride	25 mg and 75 mg	018207	1	2026-07-27
RALDESY	Oral Solution	trazodone hydrochloride	10 mg/mL	218637	1	2026-06-17
OLEPTRO	Extended-release Tablets	trazodone hydrochloride	150 mg and 300 mg	022411	1	2010-10-18

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
Sun Pharm Industries	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	073137-002	Mar 24, 1993	AB	RX	No	No
Oxford Pharms	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	072192-001	Feb 2, 1989	AB	RX	No	No
Torrent	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	202180-003	Nov 27, 2013	AB	RX	No	No
Zydus Pharms	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	205253-004	Oct 10, 2017	AB	RX	No	No
Teva Pharms Usa	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	071523-001	Dec 11, 1987	AB	RX	No	No
Torrent	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	202180-004	Nov 27, 2013	AB	RX	No	No