Viewing data from:

PAXIL CR

NDA

PAROXETINE HYDROCHLORIDE | N020936 | APOTEX INC

3 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

No FDA citizen petitions matched from Regulations.gov

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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs (1 brand, 3 generic)

Highest NADAC/Unit

$10.78

per ea

Lowest NADAC/Unit

$0.4048

per ea

Brand NDCs

Generic NDCs

Avg Brand: $10.78

Avg Generic: $0.4419

96% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
60505437803PAXIL CR 25 MG TABLET	$10.78	EA	Brand	$0.4048	2026-06-17
60505131603PAROXETINE CR 12.5 MG TABLET	$0.4929	EA	Generic	—	2026-06-17
60505131803PAROXETINE CR 37.5 MG TABLET	$0.4279	EA	Generic	—	2026-06-17
60505131703PAROXETINE CR 25 MG TABLET	$0.4048	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$4.86

Highest Price

$304.08

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
60505-1316-03PAROXETINE HCL 12.5MG TAB,SA	$8.08	FSS	Apotex Corporation	09/14/2029
60505-1316-03PAROXETINE HCL 12.5MG TAB,SA	$4.86	Big4	Apotex Corporation	09/14/2029
60505-1317-03PAROXETINE HCL 25MG TAB,SA	$7.35	FSS	Apotex Corporation	09/14/2029
60505-1317-03PAROXETINE HCL 25MG TAB,SA	$4.92	Big4	Apotex Corporation	09/14/2029
60505-1318-03PAROXETINE HCL 37.5MG TAB,SA	$8.70	FSS	Apotex Corporation	09/14/2029
60505-1318-03PAROXETINE HCL 37.5MG TAB,SA	$5.67	Big4	Apotex Corporation	09/14/2029

Showing 6 of 12 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Paxil Cr (2024)

Total Spending

$2.1M

Total Claims

3,152

Beneficiaries

648

Avg Cost/Unit

$9.61

Spending Trend

$2.7M(2019)→$2.7M(2020)→$2.6M(2021)→$2.5M(2022)→$2.5M(2023)→$2.1M(2024)

YoY Change:-0.3%

5yr CAGR:+7.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

34 letters from Drugs@FDA

Date	Submission	Document
Feb 26, 2024	SUPPL -65	View Letter (PDF)
Aug 22, 2023	SUPPL -57	View Letter (PDF)
Aug 22, 2023	SUPPL -64	View Letter (PDF)
Sep 23, 2021	SUPPL -60	View Letter (PDF)
Sep 12, 2019	SUPPL -47	View Letter (PDF)
Jan 13, 2017	SUPPL -53	View Letter (PDF)
Jul 23, 2014	SUPPL -49	View Letter (PDF)
Dec 21, 2012	SUPPL -45	View Letter (PDF)
Apr 12, 2012	SUPPL -46	View Letter (PDF)
Jul 12, 2011	SUPPL -34	View Letter (PDF)
Jul 12, 2011	SUPPL -44	View Letter (PDF)
Mar 24, 2011	SUPPL -43	View Letter (PDF)
Mar 24, 2011	SUPPL -40	View Letter (PDF)
Nov 2, 2010	SUPPL -41	View Letter (PDF)
Nov 19, 2009	SUPPL -35	View Letter (PDF)
Nov 19, 2009	SUPPL -39	View Letter (PDF)
Feb 3, 2009	SUPPL -38	View Letter (PDF)
Nov 3, 2008	SUPPL -37	View Letter (PDF)
Aug 7, 2007	SUPPL -29	View Letter (PDF)
Sep 20, 2006	SUPPL -23	View Letter (PDF)
Sep 20, 2006	SUPPL -30	View Letter (PDF)
Sep 20, 2006	SUPPL -31	View Letter (PDF)
Mar 23, 2006	SUPPL -21	View Letter (PDF)
Feb 8, 2006	SUPPL -26	View Letter (PDF)
Feb 8, 2006	SUPPL -22	View Letter (PDF)
Feb 8, 2006	SUPPL -27	View Letter (PDF)
Jul 15, 2005	SUPPL -18	View Letter (PDF)
Jan 13, 2005	SUPPL -20	View Letter (PDF)
May 27, 2004	SUPPL -19	View Letter (PDF)
Feb 2, 2004	SUPPL -13	View Letter (PDF)
Oct 17, 2003	SUPPL -12	View Letter (PDF)
Sep 9, 2003	SUPPL -11	View Letter (PDF)
Feb 12, 2002	SUPPL -8	View Letter (PDF)
Feb 16, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 12.5MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 16, 1999

No patent or exclusivity listings for this strength.

#002 — EQ 25MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 16, 1999

#003 — EQ 37.5MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 6, 2000