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PAXIL

NDA

PAROXETINE HYDROCHLORIDE | N020885 | APOTEX INC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from George W. Murgatroyd III FDA-2025-P-3263 · 41 docket documents George W. Murgatroyd III filed this citizen petition under 21 CFR 10.30 requesting that the FDA publicly disavow the 2001 Keller article in the Journal of the American Academy of Child & Adolescent Psychiatry regarding paroxetine (Paxil) for adolescent depression, issue a Drug Safety Communication w	Other	2025-08-20	Denied	George W. Murgatroyd III

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

172 trials from ClinicalTrials.gov, 134 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder NCT00839397	Phase 3	Completed	GlaxoSmithKline	52	2002-05 → 2005-06
Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers NCT02932904	Phase 4	Completed	Takeda	361	2016-11-21 → 2017-06-09
Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects NCT03329573	Phase 1	Completed	GlaxoSmithKline	85	2018-05-30 → 2018-08-03
Biological Aspects of Depression and Antidepressant Drugs NCT00018733	N/A	Completed	US Department of Veterans Affairs	—	1996-09 → 2001-12
Trial of Paroxetine-CR for the Treatment of Patients With Post Traumatic Stress Disorder Remaining Symptomatic After Initial Exposure Therapy NCT00121888	Phase 1/2	Completed	Massachusetts General Hospital	60	2002-12 → 2007-06
Study Of Generalized Anxiety Disorder NCT00135525	Phase 2	Completed	GlaxoSmithKline	—	2003-05 → 2006-05
Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects NCT00329147	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	20	2006-05 → 2006-06
A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder NCT00273039	Phase 2	Completed	GlaxoSmithKline	242	2005-08 → 2006-09
Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study NCT00177567	Phase 4	Completed	University of Pittsburgh	60	2001-07 → 2004-01
Major Depressive Disorder Study In Adults NCT00049972	Phase 4	Completed	GlaxoSmithKline	646	2002-09 → 2003-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain13 active DMFs13 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

GLAXOSMITHKLINEPAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 150392000

ZYDUS LIFESCIENCES LTDPAROXETINE HYDROCHLORIDE USP (HEMIHYDRATE)

DMF 166802003

MEDICHEM SAPAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 180522005

APITORIA PHARMA PRIVATE LTDPAROXETINE HYDROCHLORIDE (HEMIHYDRATE) USP

DMF 191522006

SUN PHARMACEUTICAL INDUSTRIES LTDPAROXETINE HYDROCHLORIDE HEMIHYDRATE USP

DMF 191782006

ORCHID PHARMA LTDPAROXETINE HYDROCHLORIDE

DMF 197512006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDPAROXETINE HYDROCHLORIDE HEMIHYDRATE USP

DMF 199222006

WANBURY LTDPAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 202482006

APOTEX INCPAROXETINE HYDROCHLORIDE ANHYDROUS USP

DMF 214402008

SIGNA SA DE CVPAROXETINE HYDROCHLORIDE HEMIHYDRATE USP

DMF 287632014

MATRIX PHARMACORP PRIVATE LTDPAROXETINE HYDROCHLORIDE USP (HEMIHYDRATE)

DMF 387932023

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTDPAROXETINE HYDROCHLORIDE

DMF 403252024

ZHEJIANG HAISEN PHARMACEUTICAL CO LTDPAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 433452025

APOTEX PHARMACHEM INCInactivePAROXETINE HYDROCHLORIDE (ANHYDROUS)

DMF 127701997

SUMITOMO CHEMICAL CO LTDInactivePAROXETINE HYDROCHLORIDE ANHYDRATE

DMF 138881998

ASAHI GLASS CO LTDInactivePAROXETINE HYDROCHLORIDE AMORPHOUS

DMF 144321999

GLAXOSMITHKLINEInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 144751999

AESICA PHARMACEUTICALS LTDInactivePAROXETINE HYDROCHLORIDE

DMF 149132000

ITF CHEMICAL LTDAInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 162472002

TEVA PHARMACEUTICAL INDUSTRIES LTDInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 164162003

CADILA HEALTHCARE LTDInactivePAROXETINE HYDROCHLORIDE, ANHYDROUS

DMF 172862004

RECORDATI ESPANA SLInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 172932004

TAIZHOU HIGHSUN PHARMACEUTICAL CO LTDInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE USP

DMF 198032006

DR REDDYS LABORATORIES LTDInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 199702006

IPCA LABORATORIES LTDInactivePAROXETINE HYDROCHLORIDE

DMF 210072008

AESICA PHARMACEUTICALS LTDInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 249602011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 9, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 9, 1998

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 9, 1998

#003 — EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 9, 1998

#004 — EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 9, 1998