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Last Updated: November 26, 2020

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BRISDELLE Drug Profile

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When do Brisdelle patents expire, and when can generic versions of Brisdelle launch?

Brisdelle is a drug marketed by Sebela Ireland Ltd and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-four patent family members in thirty-six countries.

The generic ingredient in BRISDELLE is paroxetine mesylate. There are thirty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.

US ANDA Litigation and Generic Entry Outlook for Brisdelle

A generic version of BRISDELLE was approved as paroxetine mesylate by ACTAVIS LABS FL INC on June 20th, 2017.

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Drug patent expirations by year for BRISDELLE
Drug Prices for BRISDELLE

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Drug Sales Revenue Trends for BRISDELLE

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Recent Clinical Trials for BRISDELLE

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

SponsorPhase
Noven TherapeuticsPhase 1
Noven TherapeuticsPhase 3
Noven TherapeuticsPhase 2

See all BRISDELLE clinical trials

Pharmacology for BRISDELLE
Paragraph IV (Patent) Challenges for BRISDELLE
Tradename Dosage Ingredient NDA Submissiondate
BRISDELLE CAPSULE;ORAL paroxetine mesylate 204516 2014-04-07

US Patents and Regulatory Information for BRISDELLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes   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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Merck
Medtronic
McKinsey
AstraZeneca

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