➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Harvard Business School
Moodys
Medtronic
Merck

Last Updated: June 15, 2021

DrugPatentWatch Database Preview

NEFAZODONE HYDROCHLORIDE - Generic Drug Details

« Back to Dashboard

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 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
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
  Get Started Free  Get Started Free200MGTABLET;ORAL
  Get Started Free  Get Started Free150MGTABLET;ORAL
  Get Started Free  Get Started Free100MGTABLET;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
Dr Reddys Labs Inc NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076309-004 Sep 16, 2003 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Fosun Pharma NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076302-002 Sep 16, 2003 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Sun Pharm Inds Ltd NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076409-005 Sep 16, 2003 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Fosun Pharma NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076302-001 Sep 16, 2003 DISCN No No   Get Started Free   Get Started Free   Get Started Free
>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 020152-001 Dec 22, 1994   Get Started Free   Get Started Free
Bristol Myers Squibb SERZONE nefazodone hydrochloride TABLET;ORAL 020152-003 Dec 22, 1994   Get Started Free   Get Started Free
Bristol Myers Squibb SERZONE nefazodone hydrochloride TABLET;ORAL 020152-002 Dec 22, 1994   Get Started Free   Get Started Free
Bristol Myers Squibb SERZONE nefazodone hydrochloride TABLET;ORAL 020152-006 Dec 22, 1994   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
McKesson
AstraZeneca
Mallinckrodt
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.