TRAZODONE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for trazodone hydrochloride and what is the scope of freedom to operate?

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
Alzheimer's Drug Discovery Foundation	Phase 3
Simon Ducharme, MD	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

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
Watson Labs	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	070858-001	Oct 10, 1986		DISCN	No	No
Mylan Pharms Inc	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	090514-004	Jun 2, 2009		DISCN	No	No
Mylan	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	071405-001	Feb 27, 1991		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	022411-002	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

International Patents for TRAZODONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Taiwan	200812585	Trazodone composition for once a day administration
Japan	2014221788	精製された形態のトラゾドンおよびトラゾドン塩酸塩 (PURIFIED TRAZODONE AND TRAZODONE HYDROCHLORIDE)
Spain	2389666