Viewing data from:

BRISDELLE

NDA

PAROXETINE MESYLATE | N204516 | LEGACY PHARMA INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Expiring < 1yr (2)Active (1)Today

2027

2028

2029

Today

8658663

Apr. 6, 2029

8946251

Aug. 4, 2026

9393237

Aug. 4, 2026

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
SEBELA INTERNATIONAL LIMITED et al v. PRINSTON PHARMACEUTICAL, INC. et al 2:2017cv04964	D.N.J.	2017-07-06	Terminated 2022-07-31	—
Sebela International Limited et al v. ACTAVIS LABORATORIES FL, INC. et al 2:2017cv04789	D.N.J.	2017-06-28	Terminated 2018-02-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 | 1 NDC

Highest NADAC/Unit

$2.69

per ea

Lowest NADAC/Unit

$2.69

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00574027930PAROXETINE MESYLATE 7.5 MG CAP	$2.69	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 | 1 NDC (1 FSS)

Lowest Price

$23.45

Highest Price

$23.45

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00574-0279-30BRISDELLE 7.5MG CAP,ORAL	$23.45	FSS	Padagis Sourcing Solutions LLC	09/30/2026

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

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDPAROXETINE MESYLATE

DMF 280912014

WANBURY LTDPAROXETINE MESYLATE

DMF 305732016

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Feb 12, 2025	SUPPL -14	View Letter (PDF)
Feb 12, 2025	SUPPL -9	View Letter (PDF)
Aug 22, 2023	SUPPL -13	View Letter (PDF)
Sep 22, 2021	SUPPL -11	View Letter (PDF)
May 2, 2017	SUPPL -5	View Letter (PDF)
Jan 13, 2017	SUPPL -4	View Letter (PDF)
Dec 2, 2014	SUPPL -3	View Letter (PDF)
Jul 2, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 7.5MG BASE

RLDAB

3 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jun 28, 2013

Patents (3) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8658663	Apr 6, 2029	—	Yes	Yes	—
8946251	Aug 4, 2026	—	Yes	Yes	—
9393237	Aug 4, 2026	—	—	—	—