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Last Updated: February 3, 2023

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-eight patent family members in thirty countries.

There are thirteen drug master file entries for trazodone hydrochloride. Thirty suppliers are listed for this compound.

Recent Clinical Trials for trazodone hydrochloride

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

SponsorPhase
Brigham and Women's HospitalPhase 1/Phase 2
Johns Hopkins UniversityPhase 2
Verinder SharmaPhase 1

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 Strength NDA ANDAs Submitted Submissiondate
OLEPTRO Extended-release Tablets trazodone hydrochloride 150 mg and 300 mg 022411 1 2010-10-18

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
Apotex TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071258-001 Mar 25, 1987 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Usl Pharma TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 070492-001 Apr 29, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurolife Pharma Llc TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 204852-003 Feb 5, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Angelini Pharma OLEPTRO trazodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411-001 Feb 2, 2010 See Plans and Pricing See Plans and Pricing
Pragma DESYREL trazodone hydrochloride TABLET;ORAL 018207-003 Mar 25, 1985 See Plans and Pricing See Plans and Pricing
>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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