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Last Updated: July 24, 2024

BRISDELLE Drug Patent Profile


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When do Brisdelle patents expire, and what generic alternatives are available?

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. Two suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.

DrugPatentWatch® 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

Paragraph IV (Patent) Challenges for BRISDELLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BRISDELLE Capsules paroxetine mesylate 7.5 mg 204516 1 2014-04-07

US Patents and Regulatory Information for BRISDELLE

BRISDELLE is protected by four US patents.

Patents protecting BRISDELLE

Crystalline paroxetine methane sulfonate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Method of treating thermoregulatory disfunction with paroxetine
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Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Method of treating thermoregulatory dysfunction with paroxetine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Method of treating thermoregulatory dysfunction with paroxetine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>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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