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Last Updated: October 20, 2021

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Trazodone hydrochloride - Generic Drug Details

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

Trazodone hydrochloride is the generic ingredient in four branded drugs marketed by Angelini Pharma, Pragma, Accord Hlthcare, Alvogen, Am Therap, Apotex, Apotex Inc, Aurolife Pharma Llc, Fosun Pharma, Mylan, Mylan Pharms Inc, Oxford Pharms, Pliva, Quantum Pharmics, Rising, Sun Pharm Industries, Teva, Teva Pharms Usa, Torrent, Usl Pharma, Watson Labs, and Zydus Pharms, and is included in thirty-two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Trazodone hydrochloride has seventy-seven patent family members in twenty-nine countries.

There are fourteen drug master file entries for trazodone hydrochloride. Thirty-six suppliers are listed for this compound.

Recent Clinical Trials for trazodone hydrochloride

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

SponsorPhase
Coatesville Veterans Affairs Medical CenterPhase 2
VA Office of Research and DevelopmentPhase 3
Erich SeifritzPhase 2

See all trazodone hydrochloride clinical trials

Pharmacology for trazodone hydrochloride
Medical Subject Heading (MeSH) Categories for trazodone hydrochloride
Paragraph IV (Patent) Challenges for TRAZODONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
OLEPTRO TABLET, EXTENDED RELEASE;ORAL trazodone hydrochloride 022411 2010-10-18
DESYREL TABLET;ORAL trazodone hydrochloride 018207

US Patents and Regulatory Information for trazodone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Therap TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071139-001 Oct 29, 1986 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Watson Labs TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071112-001 Nov 17, 1986 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Teva TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 074357-001 Apr 30, 1997 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Zydus Pharms TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 205253-003 Oct 10, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Accord Hlthcare TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 206923-004 Sep 8, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Pragma DESYREL trazodone hydrochloride TABLET;ORAL 018207-003 Mar 25, 1985 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever 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 trazodone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pragma DESYREL trazodone hydrochloride TABLET;ORAL 018207-003 Mar 25, 1985 ⤷  Free Forever Trial ⤷  Free Forever Trial
Angelini Pharma OLEPTRO trazodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411-001 Feb 2, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
Angelini Pharma OLEPTRO trazodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411-002 Feb 2, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
Pragma DESYREL trazodone hydrochloride TABLET;ORAL 018207-003 Mar 25, 1985 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
AstraZeneca
Dow
McKesson
Medtronic

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