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, Crossmedika Sa, Fosun Pharma, Granules, Graviti Pharms, Natco, Norvium Bioscience, 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-five 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-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:	4
Applicants:	25
NDAs:	35
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	65
Patent Applications:	2,402
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
⤷ Sign Up	⤷ Sign Up	300MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	150MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	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

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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
Alvogen	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	071514-001	Apr 18, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Therap	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	071140-001	Oct 29, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Granules	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	218988-004	Aug 8, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	022411-001	Feb 2, 2010	⤷ Sign Up	⤷ Sign Up
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010	⤷ Sign Up	⤷ Sign Up
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985	⤷ Sign Up	⤷ Sign Up
>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
Hong Kong	1139405	純化形式的曲唑酮和鹽酸曲唑酮 (TRAZODONE AND TRAZODONE HYDROCHLORIDE IN PURIFIED FORM)	⤷ Sign Up
China	101242856	Sustained drug release compositions	⤷ Sign Up
Hong Kong	1124237	TRAZODONE COMPOSITION FOR ONCE A DAY ADMINSTRATION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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