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NILUTAMIDE

ANDA

NILUTAMIDE | A207631 | ANI PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Nilutamide (2023)

Total Spending

$1.6M

Total Claims

344

Beneficiaries

Avg Cost/Unit

$149.90

Spending Trend

$3.7M(2019)→$2.7M(2020)→$2.4M(2021)→$1.9M(2022)→$1.6M(2023)

YoY Change:-3.1%

5yr CAGR:-0.8%

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.

KEKULE PHARMA LTDNILUTAMIDE

DMF 254652011

BIOPHORE INDIA PHARMACEUTICALS PVT LTDNILUTAMIDE

DMF 282622014

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 19, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 15, 2016

No patent or exclusivity listings for this strength.