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Last Updated: November 21, 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, Norvium Bioscience, 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-four 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
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
Aurobindo Pharma Usa PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091427-001 Apr 14, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 077082-003 Jun 29, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078406-002 Jul 25, 2007 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 020031-005 Dec 29, 1992 ⤷  Sign Up ⤷  Sign Up
Apotex PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-001 Feb 16, 1999 ⤷  Sign Up ⤷  Sign Up
Apotex PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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