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Last Updated: August 4, 2020

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OLEPTRO Drug Profile

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Which patents cover Oleptro, and when can generic versions of Oleptro launch?

Oleptro is a drug marketed by Angelini Pharma and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and nine patent family members in thirty-three countries.

The generic ingredient in OLEPTRO is trazodone hydrochloride. There are fourteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.

Drug patent expirations by year for OLEPTRO
Drug Sales Revenue Trends for OLEPTRO

See drug sales revenues for OLEPTRO

Recent Clinical Trials for OLEPTRO

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

SponsorPhase
Louis Stokes VA Medical CenterPhase 1
VA Connecticut Healthcare SystemPhase 4
Algorithme Pharma IncPhase 1

See all OLEPTRO clinical trials

Paragraph IV (Patent) Challenges for OLEPTRO
Tradename Dosage Ingredient NDA Submissiondate
OLEPTRO TABLET, EXTENDED RELEASE;ORAL trazodone hydrochloride 022411 2010-10-18

US Patents and Regulatory Information for OLEPTRO

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
Angelini Pharma OLEPTRO trazodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411-002 Feb 2, 2010 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Angelini Pharma OLEPTRO trazodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411-001 Feb 2, 2010 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Angelini Pharma OLEPTRO trazodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411-001 Feb 2, 2010 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Angelini Pharma OLEPTRO trazodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411-002 Feb 2, 2010 DISCN Yes No   Start Trial   Start Trial Y   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
>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 OLEPTRO

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
Angelini Pharma OLEPTRO trazodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411-002 Feb 2, 2010   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:

Medtronic
Merck
McKesson
Express Scripts
Boehringer Ingelheim
Baxter

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