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Last Updated: March 29, 2024

PAROXETINE HYDROCHLORIDE Drug Patent Profile


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

Paroxetine Hydrochloride is a drug marketed by Apotex Inc, Novitium Pharma, Aurobindo Pharma Usa, Cadila Pharms Ltd, Cspc Ouyi, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Prinston Inc, Sciecure Pharma Inc, Apotex, Aurobindo Pharma, Chartwell Rx, Jubilant Generics, Mylan, Mylan Pharms Inc, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva Pharms, Upsher Smith Labs, Yiling, and Zydus Pharms Usa. and is included in twenty-four NDAs.

The generic ingredient in PAROXETINE HYDROCHLORIDE is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Paroxetine Hydrochloride

A generic version of PAROXETINE HYDROCHLORIDE was approved as paroxetine hydrochloride by APOTEX on July 30th, 2003.

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Drug patent expirations by year for PAROXETINE HYDROCHLORIDE
Recent Clinical Trials for PAROXETINE HYDROCHLORIDE

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SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Cairo UniversityPhase 3
AbbViePhase 4

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Pharmacology for PAROXETINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for PAROXETINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for PAROXETINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PAXIL CR Extended-release Tablets paroxetine hydrochloride 37.5 mg 020936 1 2009-05-19
PAXIL CR Extended-release Tablets paroxetine hydrochloride 25 mg 020936 1 2005-09-09

US Patents and Regulatory Information for PAROXETINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Yiling PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 211248-003 Nov 2, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jubilant Generics PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 205528-004 Nov 27, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078406-003 Jul 25, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Pharms Inc PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 075716-004 Mar 8, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Inc PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078194-003 Jun 29, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078902-004 Mar 13, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Oxford Pharms PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 076968-001 Jun 21, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

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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.