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Last Updated: November 20, 2019

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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 patent family members in thirty-five 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.

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

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SponsorPhase
Noven TherapeuticsPhase 1
Noven TherapeuticsPhase 3
Noven TherapeuticsPhase 2

See all BRISDELLE clinical trials

Recent Litigation for BRISDELLE

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District Court Litigation
Case NameDate
SEBELA INTERNATIONAL LIMITED v. PRINSTON PHARMACEUTICAL, INC.2017-07-06
Sebela International Limited v. ACTAVIS LABORATORIES FL, INC.2017-06-28
IN RE SEBELA PATENT LITIGATION2014-10-16

See all BRISDELLE litigation

Pharmacology for BRISDELLE
Synonyms for BRISDELLE
(3S,4R)-3-((Benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine methanesulfonate
217797-14-3
AKOS027321054
Brisdelle (TN)
CHEMBL1200609
D05375
LDMP
M711N184JE
Paroxetine Mesilate
Paroxetine Mesylate
Paroxetine mesylate (USAN)
Paroxetine Mesylate [USAN]
Paroxetine methanesulphonate
Pexeva
Pexeva (TN)
POT.mes
SCHEMBL143905
SHIJTGJXUHTGGZ-RVXRQPKJSA-N
UNII-M711N184JE
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   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
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   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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Dow
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Moodys

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