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Last Updated: March 6, 2021

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Nefazodone hydrochloride - Generic Drug Details

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What are the generic drug 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 Inc, Dr Reddys Labs Inc, Fosun Pharma, Ivax Sub Teva Pharms, Mylan, 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 four drug master file entries for nefazodone hydrochloride. Three suppliers are 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: 4
Suppliers / Packagers: 3
Bulk Api Vendors: 89
Clinical Trials: 16
Patent Applications: 1,566
Formulation / Manufacturing:see details
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

SponsorPhase
Maimonides Medical CenterPhase 2
Instituto Nacional de Salud Publica, MexicoPhase 3
Laboratorios Grossman, S.A.Phase 3

See all nefazodone hydrochloride clinical trials

Generic filers with tentative approvals for NEFAZODONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MGTABLET;ORAL
  Start Trial  Start Trial150MGTABLET;ORAL
  Start Trial  Start Trial100MGTABLET;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
Paragraph IV (Patent) Challenges for NEFAZODONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
SERZONE TABLET;ORAL nefazodone hydrochloride 020152

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
Roxane NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076196-002 Sep 16, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Fosun Pharma NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076302-004 Sep 16, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 075763-003 Sep 16, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076072-001 Sep 16, 2003 DISCN No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Bristol Myers Squibb SERZONE nefazodone hydrochloride TABLET;ORAL 020152-001 Dec 22, 1994   Start Trial   Start Trial
Bristol Myers Squibb SERZONE nefazodone hydrochloride TABLET;ORAL 020152-002 Dec 22, 1994   Start Trial   Start Trial
Bristol Myers Squibb SERZONE nefazodone hydrochloride TABLET;ORAL 020152-006 Dec 22, 1994   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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AstraZeneca

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