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Last Updated: November 21, 2024

PAROXETINE HYDROCHLORIDE Drug Patent Profile

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When do Paroxetine Hydrochloride patents expire, and what generic alternatives are available?

Paroxetine Hydrochloride is a drug marketed by 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, Apotex, 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-four NDAs.

The generic ingredient in PAROXETINE HYDROCHLORIDE is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Paroxetine Hydrochloride

A generic version of PAROXETINE HYDROCHLORIDE was approved as paroxetine hydrochloride by APOTEX on July 30^th, 2003.

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Summary for PAROXETINE HYDROCHLORIDE

US Patents:	0
Applicants:	23
NDAs:	24
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	259
Patent Applications:	1,037
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PAROXETINE HYDROCHLORIDE
What excipients (inactive ingredients) are in PAROXETINE HYDROCHLORIDE?	PAROXETINE HYDROCHLORIDE excipients list
DailyMed Link:	PAROXETINE HYDROCHLORIDE at DailyMed

Drug patent expirations by year for PAROXETINE HYDROCHLORIDE

Recent Clinical Trials for PAROXETINE HYDROCHLORIDE

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

Sponsor	Phase
First Affiliated Hospital Xi'an Jiaotong University	N/A
Cairo University	Phase 3
AbbVie	Phase 4

See all PAROXETINE HYDROCHLORIDE clinical trials

Pharmacology for PAROXETINE HYDROCHLORIDE

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PAROXETINE HYDROCHLORIDE

N06AB	Selective serotonin reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Yiling	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	211248-003	Nov 2, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Jubilant Generics	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	205528-004	Nov 27, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	078406-003	Jul 25, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	075716-004	Mar 8, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Inc	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	078194-003	Jun 29, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	078902-004	Mar 13, 2008	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

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