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Last Updated: March 19, 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 patent protection?

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
The Medical Research NetworkPhase 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
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
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-004 Dec 29, 1992 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 075356-003 Jul 30, 2003 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms Usa PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 077584-001 Mar 7, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sciecure Pharma Inc PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209293-001 Jun 12, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms Usa PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 077584-002 Mar 7, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 076618-003 Aug 15, 2005 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 020031-005 Dec 29, 1992 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-004 Dec 29, 1992 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-004 Oct 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-003 Dec 29, 1992 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride SUSPENSION;ORAL 020710-001 Jun 25, 1997 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-003 Dec 29, 1992 ⤷  Try a Trial ⤷  Try a Trial
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-001 Oct 9, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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