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Last Updated: February 26, 2024

Paroxetine mesylate - Generic Drug Details


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What are the generic sources for paroxetine mesylate and what is the scope of patent protection?

Paroxetine mesylate is the generic ingredient in three branded drugs marketed by Sebela Ireland Ltd, Actavis Labs Fl Inc, and Prinston Inc, and is included in four NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paroxetine mesylate has eighty-four patent family members in thirty-six countries.

There are two drug master file entries for paroxetine mesylate. Three suppliers are listed for this compound.

Drug Prices for paroxetine mesylate

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Recent Clinical Trials for paroxetine mesylate

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

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Alphacait, LLCPhase 2
Noven TherapeuticsPhase 1

See all paroxetine mesylate clinical trials

Pharmacology for paroxetine mesylate
Paragraph IV (Patent) Challenges for PAROXETINE MESYLATE
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 paroxetine mesylate

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-004 Jul 3, 2003 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-003 Jul 3, 2003 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 paroxetine mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-002 Jul 3, 2003 ⤷  Try a Trial ⤷  Try a Trial
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 ⤷  Try a Trial ⤷  Try a Trial
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-004 Jul 3, 2003 ⤷  Try a Trial ⤷  Try a Trial
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-001 Jul 3, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for paroxetine mesylate

Country Patent Number Title Estimated Expiration
Serbia 57980 POSTUPAK LEČENJA TERMOREGULACIONE DISFUNKCIJE PAROKSETINOM (METHOD OF TREATING THERMOREGULATORY DISFUNCTION WITH PAROXETINE) ⤷  Try a Trial
Montenegro 00592 POSTUPAK LIJEČENJA TERMOREGULACIONE DISFUNKCIJE PAROKSETINOM (METHOD OF TREATING THERMOREGULATORY DISFUNCTION WITH PAROXETINE) ⤷  Try a Trial
Spain 2698207 ⤷  Try a Trial
Slovenia 0994872 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
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Johnson and Johnson

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