Trazodone hydrochloride - Generic Drug Details

What are the generic sources for trazodone hydrochloride and what is the scope of patent protection?

Trazodone hydrochloride is the generic ingredient in five branded drugs marketed by Kamat, Angelini Pharma, Pragma, 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-six NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Thirty-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for trazodone hydrochloride

International Patents:	78
US Patents:	2
Tradenames:	5
Applicants:	26
NDAs:	36
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
What excipients (inactive ingredients) are in trazodone hydrochloride?	trazodone hydrochloride excipients list
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
Brigham and Women's Hospital	PHASE4
University of Pittsburgh	PHASE4

See all trazodone hydrochloride clinical trials

Generic filers with tentative approvals for TRAZODONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		300MG	TABLET;ORAL
		150MG	TABLET;ORAL
		100MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Graviti Pharms	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	217740-002	Aug 27, 2024	AB	RX	No	No
Accord Hlthcare	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	206923-001	Sep 8, 2017	AB	RX	No	No
Usl Pharma	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	070491-001	Apr 29, 1987		DISCN	No	No

Expired US Patents for trazodone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-001	Feb 2, 2010	6,607,748
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010	6,607,748
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985	4,215,104

International Patents for trazodone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Argentina	059678
Argentina	059682
Argentina	109571