PAXIL Drug Patent Profile

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Which patents cover Paxil, and when can generic versions of Paxil launch?

Paxil is a drug marketed by Apotex and is included in four NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Paxil

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

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Summary for PAXIL

US Patents:	0
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Patent Applications:	3,738
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PAXIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PAXIL
What excipients (inactive ingredients) are in PAXIL?	PAXIL excipients list
DailyMed Link:	PAXIL at DailyMed

Drug patent expirations by year for PAXIL

Pharmacology for PAXIL

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PAXIL

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

US Patents and Regulatory Information for PAXIL

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Glossary

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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
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-001	Oct 9, 1998		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-002	Dec 29, 1992	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-004	Oct 9, 1998		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-002	Feb 16, 1999	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-003	Dec 29, 1992	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-002	Oct 9, 1998		DISCN	Yes	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 PAXIL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-001	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
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-001	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
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-002	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PAXIL

See the table below for patents covering PAXIL around the world.

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Country	Patent Number	Title	Estimated Expiration
Sweden	521084	Förfarande för framställning av paroxetin-hydroklorid- anhydrat från ett paroxetin-hydroklorid-solvat	⤷ Try a Trial
Spain	2209428		⤷ Try a Trial
Canada	2211521		⤷ Try a Trial
Switzerland	688353	Formen von Paroxetin-Hydrochlorid.	⤷ Try a Trial
European Patent Office	0734260	COMPRIMES DE PAROXETINE ET LEUR PROCEDE DE PREPARATION (PAROXETINE TABLETS AND PROCESS TO PREPARE THEM)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	9516448		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for PAXIL

Pharmacology for PAXIL

Anatomical Therapeutic Chemical (ATC) Classes for PAXIL

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