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Last Updated: December 4, 2022

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

See drug prices for paroxetine mesylate

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 PEXEVA paroxetine mesylate TABLET;ORAL 021299-002 Jul 3, 2003 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Prinston Inc PAROXETINE MESYLATE paroxetine mesylate CAPSULE;ORAL 207188-001 Aug 18, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-001 Jul 3, 2003 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Actavis Labs Fl Inc PAROXETINE MESYLATE paroxetine mesylate CAPSULE;ORAL 207139-001 Jun 20, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for paroxetine mesylate

Country Patent Number Title Estimated Expiration
Canada 2659577 METHODE POUR TRAITER UN DYSFONCTIONNEMENT DE THERMOREGULATION AVEC DE LA PAROXETINE (METHOD OF TREATING THERMOREGULATORY DISFUNCTION WITH PAROXETINE) See Plans and Pricing
Norway 20033765 See Plans and Pricing
Germany 69704679 See Plans and Pricing
Denmark 0994872 See Plans and Pricing
Czech Republic 295301 Deriváty 4-fenylpiperidinu, způsob jejich přípravy, jejich použití a lék je obsahující (4-Phenylpiperidine derivatives, process of their preparation, their use and medicament in which the derivatives are comprised) See Plans and Pricing
Canada 2293247 COMPOSES 4-PHENYLPIPERIDINE (4-PHENYLPIPERIDINE COMPOUNDS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.