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Last Updated: August 4, 2020

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Details for New Drug Application (NDA): 022411

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NDA 022411 describes OLEPTRO, which 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. Additional details are available on the OLEPTRO profile page.

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.
Summary for 022411
Applicant:Angelini Pharma
Ingredient:trazodone hydrochloride
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 022411
Tradename Dosage Ingredient NDA Submissiondate
OLEPTRO TABLET, EXTENDED RELEASE;ORAL trazodone hydrochloride 022411 2010-10-18

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 2, 2010TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 27, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 022411

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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