NEFAZODONE HYDROCHLORIDE - Generic Drug Details

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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
Instituto Nacional de Salud Publica, Mexico	Phase 3
Laboratorios Grossman, S.A.	Phase 3
Durham VA Medical Center	Phase 2

See all NEFAZODONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for NEFAZODONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	250MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	200MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	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

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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
Watson Labs	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076073-004	Sep 16, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076073-005	Sep 16, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076409-003	Sep 16, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Sub Teva Pharms	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	075763-002	Sep 16, 2003		DISCN	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 NEFAZODONE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-005	Dec 22, 1994	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-002	Dec 22, 1994	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-004	Dec 22, 1994	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-006	Dec 22, 1994	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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