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FLUVOXAMINE MALEATE

ANDA

FLUVOXAMINE MALEATE | A075887 | UPSHER SMITH LABORATORIES LLC

3 strengths0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Fluvoxamine Maleate (2023)

Total Spending

$17.9M

Total Claims

384,679

Beneficiaries

51,310

Avg Cost/Unit

$0.72

Spending Trend

$13.5M(2019)→$15.1M(2020)→$18.5M(2021)→$19.8M(2022)→$17.9M(2023)

YoY Change:-10.3%

5yr CAGR:+3.5%

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
Jan 5, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 5, 2001

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 5, 2001

#003 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 5, 2001