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Last Updated: December 7, 2022

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, Lannett Co Inc, Lupin Ltd, Sciecure Pharma Inc, Sinotherapeutics Inc, Prinston 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-eight NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for paroxetine hydrochloride

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

SponsorPhase
AbbViePhase 4
The Medical Research NetworkPhase 4
University of TorontoPhase 3

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
Upsher Smith Labs PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 075566-003 Mar 8, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078902-001 Mar 13, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078902-002 Mar 13, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jubilant Generics PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 205528-004 Nov 27, 2015 DISCN 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
Aurobindo Pharma PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET;ORAL 078406-002 Jul 25, 2007 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

Expired US Patents for paroxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-004 Oct 9, 1998 See Plans and Pricing See Plans and Pricing
Apotex PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-002 Feb 16, 1999 See Plans and Pricing See Plans and Pricing
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-003 Oct 9, 1998 See Plans and Pricing See Plans and Pricing
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-004 Dec 29, 1992 See Plans and Pricing See Plans and Pricing
Apotex PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-003 Dec 6, 2000 See Plans and Pricing See Plans and Pricing
Apotex PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-002 Feb 16, 1999 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.