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Last Updated: March 19, 2024

Nefazodone hydrochloride - Generic Drug Details


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What are the generic sources for nefazodone hydrochloride and what is the scope of patent protection?

Nefazodone hydrochloride is the generic ingredient in two branded drugs marketed by Ani Pharms, Aurobindo Pharma Usa, Dr Reddys Labs Inc, Fosun Pharma, 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
Recent Clinical Trials for nefazodone hydrochloride

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

SponsorPhase
Laboratorios Grossman, S.A.Phase 3
Instituto Nacional de Salud Publica, MexicoPhase 3
VA Office of Research and DevelopmentPhase 2

See all nefazodone hydrochloride clinical trials

Generic filers with tentative approvals for NEFAZODONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial250MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial200MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial150MGTABLET;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
Anatomical Therapeutic Chemical (ATC) Classes for nefazodone hydrochloride

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
Watson Labs NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076073-002 Sep 16, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076196-004 Sep 16, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SERZONE nefazodone hydrochloride TABLET;ORAL 020152-005 Dec 22, 1994 DISCN Yes 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 nefazodone hydrochloride

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

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