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Last Updated: June 28, 2022

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, Lannett Co Inc, Lupin Ltd, Sciecure Pharma Inc, Sinotherapeutics 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-three NDAs.

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

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

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SponsorPhase
University of New MexicoPhase 2
University Hospital, Basel, SwitzerlandPhase 1
Everest Clinical ResearchPhase 2

See all PAROXETINE HYDROCHLORIDE clinical trials

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

PAROXETINE HYDROCHLORIDE is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting PAROXETINE HYDROCHLORIDE

COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: 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
Zydus Pharms Usa PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 077584-002 Mar 7, 2007 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078902-003 Mar 13, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chartwell Rx PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 076618-002 Aug 15, 2005 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Oxford Pharms PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 076968-003 Jun 21, 2010 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

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