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Last Updated: July 12, 2020

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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, Sun Pharm Industries, Teva, Teva Pharms Usa, Torrent, Usl Pharma, Watson Labs, and Zydus Pharms, and is included in thirty-two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Trazodone hydrochloride has one hundred and nine patent family members in thirty-three countries.

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

Recent Clinical Trials for trazodone hydrochloride

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

SponsorPhase
VA Office of Research and DevelopmentPhase 3
Erich SeifritzPhase 2
Chang Gung Memorial HospitalPhase 4

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
Angelini Pharma OLEPTRO trazodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411-001 Feb 2, 2010 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Oxford Pharms TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 072193-001 Feb 2, 1989 AB RX No No   Start Trial   Start Trial   Start Trial
Pliva TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071525-001 Mar 9, 1988 AB RX No No   Start Trial   Start Trial   Start Trial
Torrent TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 202180-001 Nov 27, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Angelini Pharma OLEPTRO trazodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411-002 Feb 2, 2010 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Teva Pharms Usa TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071524-001 Dec 11, 1987 AB RX No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 072484-001 Apr 30, 1990 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 trazodone hydrochloride

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