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Last Updated: March 28, 2024

PAROXETINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for paroxetine hydrochloride and what is the scope of freedom to operate?

Paroxetine hydrochloride is the generic ingredient in four branded drugs marketed by Apotex, 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, 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-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for paroxetine hydrochloride. Forty-two suppliers are listed for this compound.

Recent Clinical Trials for PAROXETINE HYDROCHLORIDE

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

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

See all PAROXETINE HYDROCHLORIDE clinical trials

Pharmacology 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
Sciecure Pharma Inc PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209293-003 Jun 12, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Yiling PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 211248-001 Nov 2, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Prinston Inc PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209748-001 Jan 4, 2024 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

Expired US Patents for PAROXETINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-003 Dec 29, 1992 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-001 Dec 29, 1992 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-002 Feb 16, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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