Viewing data from:

PEXEVA

NDA

PAROXETINE MESYLATE | N021299 | SEBELA IRELAND LTD

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

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

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

Medicare Part D Spending

CMS annual spending data for Pexeva (2023)

Total Spending

$508K

Total Claims

594

Beneficiaries

157

Avg Cost/Unit

$15.45

Spending Trend

$1.2M(2019)→$1.1M(2020)→$1.0M(2021)→$1.0M(2022)→$508K(2023)

YoY Change:+3.8%

5yr CAGR:+4.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

23 letters from Drugs@FDA

Date	Submission	Document
Aug 22, 2023	SUPPL -38	View Letter (PDF)
Aug 22, 2023	SUPPL -35	View Letter (PDF)
Sep 21, 2021	SUPPL -37	View Letter (PDF)
Jan 4, 2021	SUPPL -31	View Letter (PDF)
Jan 10, 2017	SUPPL -33	View Letter (PDF)
Jul 24, 2014	SUPPL -32	View Letter (PDF)
Dec 21, 2012	SUPPL -28	View Letter (PDF)
Dec 21, 2012	SUPPL -29	View Letter (PDF)
Dec 21, 2012	SUPPL -27	View Letter (PDF)
Apr 29, 2011	SUPPL -24	View Letter (PDF)
Feb 5, 2010	SUPPL -22	View Letter (PDF)
Feb 3, 2009	SUPPL -23	View Letter (PDF)
Mar 7, 2008	SUPPL -21	View Letter (PDF)
Oct 10, 2007	SUPPL -20	View Letter (PDF)
Aug 7, 2007	SUPPL -19	View Letter (PDF)
Dec 28, 2006	SUPPL -17	View Letter (PDF)
Dec 28, 2006	SUPPL -16	View Letter (PDF)
Dec 28, 2006	SUPPL -18	View Letter (PDF)
Jan 13, 2005	SUPPL -13	View Letter (PDF)
Aug 31, 2004	SUPPL -7	View Letter (PDF)
Jun 18, 2004	ORIG -1	View Letter (PDF)
Jun 18, 2004	ORIG -1	View Letter (PDF)
Aug 28, 2003	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 10MG BASE

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 3, 2003

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 3, 2003

#003 — EQ 30MG BASE

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 3, 2003

#004 — EQ 40MG BASE

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 3, 2003