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 four branded drugs marketed by Angelini Pharma, Pragma, Accord Hlthcare, Alvogen, Am Therap, Apotex, Apotex Inc, Aurobindo Pharma, Fosun Pharma, Mylan, Mylan Pharms Inc, Oxford Pharms, 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. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Trazodone hydrochloride has seventy-eight patent family members in thirty countries.

There are thirteen drug master file entries for trazodone hydrochloride. Thirty-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for trazodone hydrochloride

International Patents:	78
US Patents:	2
Tradenames:	4
Applicants:	22
NDAs:	32
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	65
Patent Applications:	7,270
Formulation / Manufacturing:	see details
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
Simon Ducharme, MD	Phase 3
Alzheimer's Drug Discovery Foundation	Phase 3
University of New Mexico	Phase 4

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
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
Torrent	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	202180-003	Nov 27, 2013	AB	RX	No	No
Aurobindo Pharma	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	204852-002	Feb 5, 2020	AB	RX	No	No
Apotex Inc	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	071196-001	Mar 25, 1987	AB	RX	No	Yes
Alvogen	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	071636-001	Apr 18, 1988		DISCN	No	No
Zydus Pharms	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	205253-003	Oct 10, 2017	AB	RX	No	No
Sun Pharm Industries	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	073137-001	Mar 24, 1993	AB	RX	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	022411-002	Feb 2, 2010
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-001	Feb 2, 2010
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985

International Patents for trazodone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Norway	342381
Eurasian Patent Organization	200800783	КОМПОЗИЦИЯ ТРАЗОДОНА ДЛЯ ВВЕДЕНИЯ ОДИН РАЗ В ДЕНЬ
South Korea	101505522
Canada	2616204	COMPOSITION MEDICAMENTEUSE A LIBERATION PROLONGEE (SUSTAINED DRUG RELEASE COMPOSITION)
Mexico	2010001094	TRAZODONA Y HIDROCLORURO DE TRAZODONA EN FORMA PURIFICADA. (TRAZODONE AND TRAZODONE HYDROCHLORIDE IN PURIFIED FORM.)
Japan	5269595