NEFAZODONE HYDROCHLORIDE - Generic Drug Details

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

Nefazodone hydrochloride is the generic ingredient in two branded drugs marketed by Ani Pharms, Aurobindo Pharma Usa, Chartwell Rx, Dr Reddys Labs Inc, Ivax Sub Teva Pharms, Roxane, Sun Pharm Inds Ltd, Teva, Watson Labs, and Bristol Myers Squibb, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for nefazodone hydrochloride. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for NEFAZODONE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	16
Patent Applications:	1,745
What excipients (inactive ingredients) are in NEFAZODONE HYDROCHLORIDE?	NEFAZODONE HYDROCHLORIDE excipients list
DailyMed Link:	NEFAZODONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for NEFAZODONE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Laboratorios Grossman, S.A.	Phase 3
Instituto Nacional de Salud Publica, Mexico	Phase 3
San Diego Veterans Healthcare System	Phase 2

See all NEFAZODONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for NEFAZODONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		250MG	TABLET;ORAL
		200MG	TABLET;ORAL
		150MG	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 NEFAZODONE HYDROCHLORIDE

Drug Class

Serotonin Reuptake Inhibitor

Anatomical Therapeutic Chemical (ATC) Classes for NEFAZODONE HYDROCHLORIDE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for NEFAZODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076302-002	Sep 16, 2003		DISCN	No	No
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-003	Dec 22, 1994		DISCN	Yes	No
Teva	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076037-004	Sep 16, 2003		RX	No	No
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-004	Dec 22, 1994		DISCN	Yes	No
Roxane	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076196-005	Sep 16, 2003		DISCN	No	No
Roxane	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076196-004	Sep 16, 2003		DISCN	No	No

Expired US Patents for NEFAZODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-006	Dec 22, 1994
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-001	Dec 22, 1994
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-002	Dec 22, 1994
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-003	Dec 22, 1994
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-004	Dec 22, 1994
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-004	Dec 22, 1994