Viewing data from:

LUVOX

NDA

FLUVOXAMINE MALEATE | N020243 | SOLVAY PHARMACEUTICALS

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 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Fluvoxamine for Long COVID-19 NCT05874037	Phase 2/3	Completed	Washington University School of Medicine	191	2023-05-15 → 2025-03-15

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

Medicare Part D Spending

CMS annual spending data for Fluvoxamine Maleate ER (2023)

Total Spending

$8.6M

Total Claims

21,851

Beneficiaries

3,459

Avg Cost/Unit

$6.89

Spending Trend

$7.1M(2019)→$7.7M(2020)→$8.1M(2021)→$8.5M(2022)→$8.6M(2023)

YoY Change:-7.8%

5yr CAGR:-2.0%

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

API Supply Chain11 active DMFs3 inactive

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

TAPI NL BVFLUVOXAMINE MALEATE

DMF 139131998

MEDICHEM SAFLUVOXAMINE MALEATE

DMF 145111999

APOTEX PHARMACHEM INDIA PVT LTDFLUVOXAMINE MALEATE USP

DMF 145291999

SUN PHARMACEUTICAL INDUSTRIES LTDFLUVOXAMINE MALEATE USP

DMF 161742002

VERANOVA LPFLUVOXAMINE MALEATE (SVB)

DMF 205692007

LONZA AGFLUVOXAMINE MALEATE (SV-006)

DMF 252012011

COHANCE LIFESCIENCES LTDFLUVOXAMINE MALEATE USP

DMF 295822015

DASAMI LAB PRIVATE LTDFLUVOXAMINE MALEATE USP

DMF 363032021

JEWIM PHARMACEUTICAL (SHANDONG) CO LTDFLUVOXAMINE MALEATE

DMF 390192023

ALIVUS LIFE SCIENCES LTDFLUVOXAMINE MALEATE USP

DMF 416102025

SHANDONG RISEN-SUN PHARMACEUTICAL CO LTDFLUVOXAMINE MALEATE

DMF 432652025

VIS FARMACEUTICI INSTITUTO SCIENTIFICO VINEZIE SPAInactiveFLUVOXAMINE MALEATE

DMF 123531997

DIOSYNTH BVInactiveFLUVOXAMINE MALEATE

DMF 138921998

ALKERMES INCInactiveFLUVOXAMINE MALEATE CR CAPSULES

DMF 139571999

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 28, 2000	SUPPL -21	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 5, 1994

No patent or exclusivity listings for this strength.

#002 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 5, 1994

#003 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 5, 1994

#004 — 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 5, 1994