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Last Updated: April 28, 2024

TRAZODONE HYDROCHLORIDE - Generic Drug Details

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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
⤷ Try a Trial	⤷ Try a Trial	300MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	150MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Watson Labs	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	071112-001	Nov 17, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Am Therap	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	071139-001	Oct 29, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Usl Pharma	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	070492-001	Apr 29, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for TRAZODONE HYDROCHLORIDE

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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	⤷ Try a Trial	⤷ Try a Trial
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-001	Feb 2, 2010	⤷ Try a Trial	⤷ Try a Trial
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985	⤷ Try a Trial	⤷ Try a Trial
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TRAZODONE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Argentina	109571	COMPOSICIÓN DE TRAZODONA PARA ADMINISTRACIÓN UNA VEZ POR DÍA	⤷ Try a Trial
Australia	2006308449	Trazodone composition for once a day adminisitiation	⤷ Try a Trial
Slovenia	1931346		⤷ Try a Trial
Canada	2616416	COMPOSITION DE TRAZODONE A ADMINISTRATION QUOTIDIENNE (TRAZODONE COMPOSITION FOR ONCE A DAY ADMINISITIATION)	⤷ Try a Trial
Poland	2178850		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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