PAXIL Drug Patent Profile

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

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.

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

See drug prices for PAXIL

See drug sales revenues 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

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
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-002	Dec 29, 1992	AB	RX	Yes	No
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-004	Oct 9, 1998		DISCN	Yes	No

Expired US Patents for PAXIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-002	Oct 9, 1998
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-001	Oct 9, 1998
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-005	Dec 29, 1992

International Patents for PAXIL

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	297171	Anhydrát paroxetin-hydrochloridu, zpusob jeho prípravy, farmaceutický prostredek s jeho obsahem a pouzití (Paroxetine-hydrochloride anhydrate, process for its preparation, and pharmaceutical composition in which the anhydrate is comprised and use thereof)
Brazil	9408219
European Patent Office	1020463