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Last Updated: March 5, 2021

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Paroxetine hydrochloride - Generic Drug Details

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

Paroxetine hydrochloride is the generic ingredient in four branded drugs marketed by Apotex Technologies, Apotex Inc, Lannett Co Inc, Lupin Ltd, Mylan, Sciecure Pharma Inc, Prinston Inc, Apotex, Aurobindo Pharma, Jubilant Generics, Mylan Pharms Inc, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva, Teva Pharms, Upsher Smith Labs, and Zydus Pharms Usa, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty drug master file entries for paroxetine hydrochloride. Thirty-eight suppliers are listed for this compound.

Recent Clinical Trials for paroxetine hydrochloride

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

SponsorPhase
Washington State UniversityN/A
Harvard UniversityN/A
Patient-Centered Outcomes Research InstituteN/A

See all paroxetine hydrochloride clinical trials

Pharmacology for paroxetine hydrochloride
Paragraph IV (Patent) Challenges for PAROXETINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
PAXIL CR TABLET, EXTENDED RELEASE;ORAL paroxetine hydrochloride 020936 2009-05-19
PAXIL CR TABLET, EXTENDED RELEASE;ORAL paroxetine hydrochloride 020936 2005-09-09
PAXIL SUSPENSION;ORAL paroxetine hydrochloride 020710 2005-02-10
PAXIL TABLET;ORAL paroxetine hydrochloride 020031
PAXIL CAPSULE;ORAL paroxetine hydrochloride 020885

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
Apotex Technologies PAXIL paroxetine hydrochloride TABLET;ORAL 020031-003 Dec 29, 1992 AB RX Yes No   Start Trial   Start Trial   Start Trial
Prinston Inc PAROXETINE paroxetine hydrochloride TABLET;ORAL 203854-001 Oct 31, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Jubilant Generics PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 205528-004 Nov 27, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Upsher Smith Labs PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 075566-004 Mar 8, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex Technologies PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-001 Feb 16, 1999 AB RX Yes No   Start Trial   Start Trial   Start Trial
Lannett Co Inc PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 204744-001 Jun 10, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 077082-004 Jun 29, 2007 DISCN No No   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

Expired US Patents for paroxetine hydrochloride

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