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

177 trials from ClinicalTrials.gov — 3 recruiting, 136 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Phase I Study of NS-079 in Healthy Participants NCT07669571	Phase 1	Not Yet Recruiting	NeuShen Therapeutics	78	2026-06 → 2027-05
A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors NCT07070232	Phase 1/2	Recruiting	BioNTech SE	1,438	2025-08-12 → 2030-03
Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia NCT07715669	Early Phase 1	Recruiting	Anna Stanhewicz, PhD	40	2026-08-30 → 2027-06
Paroxetine for the Treatment of Interferon Related Side Effects for Hepatitis C NCT00209118	N/A	Completed	Emory University	60	— → 2005-07
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-059)NCT00035009	Phase 3	Completed	Merck Sharp & Dohme LLC	468	2001-09-20 → 2004-03-24
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-066)(COMPLETED)NCT00034983	Phase 3	Completed	Merck Sharp & Dohme LLC	900	2001-10-29 → 2003-12-29
Concentration-QT Study of Paroxetine in Healthy Adults NCT06065735	Phase 1	Completed	GlaxoSmithKline	38	2023-10-02 → 2024-01-08
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-062)(COMPLETED)NCT00048607	Phase 3	Completed	Merck Sharp & Dohme LLC	600	2002-07-30 → 2003-12-31
Naltrexone & SSRI in Alcoholics With Depression/PTSD NCT00338962	Phase 3	Completed	Yale University	88	2001-10 → 2015-07
Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine NCT00357045	Phase 4	Completed	Portland VA Medical Center	—	—

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 4 NDCs (1 brand, 3 generic)

Highest NADAC/Unit

$10.80

per ea

Lowest NADAC/Unit

$0.3997

per ea

Brand NDCs

Generic NDCs

Avg Brand: $10.80

Avg Generic: $0.4325

96% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
60505437803PAXIL CR 25 MG TABLET	$10.80	EA	Brand	$0.4061	2026-08-19
60505131603PAROXETINE CR 12.5 MG TABLET	$0.4918	EA	Generic	—	2026-08-19
60505131703PAROXETINE CR 25 MG TABLET	$0.4061	EA	Generic	—	2026-08-19
60505131803PAROXETINE CR 37.5 MG TABLET	$0.3997	EA	Generic	—	2026-08-19

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