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PROCHLORPERAZINE

ANDA

PROCHLORPERAZINE | A040058 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Prochlorperazine (2023)

Total Spending

$380K

Total Claims

3,267

Beneficiaries

2,594

Avg Cost/Unit

$7.77

Spending Trend

$1.1M(2019)→$1.2M(2020)→$1.0M(2021)→$877K(2022)→$380K(2023)

YoY Change:+8.1%

5yr CAGR:+1.1%

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

API Supply Chain2 active DMFs3 inactive

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

TRIFARMA SPAPROCHLORPERAZINE BASE

DMF 198902006

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPROCHLORPERAZINE

DMF 314962017

ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES)InactivePROCHLORPERAZINE

DMF 58031985

FINE CHEMICALS CORP PTY LTDInactivePROCHLORPERAZINE DIMALEATE

DMF 75981988

FINE CHEMICALS CORPInactivePROCHLORPERAZINE MESYLATE

DMF 97951992

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

Products (1)

#001 — 25MG

0 patents0 exclusivities▴

SUPPOSITORY;RECTAL | Approved: Nov 24, 1993

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals expanded its applicant name on the Orange Book listing for prochlorperazine (NDA 040058) from "Cosette" to "Cosette Pharms NC."

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals changed its legal entity name to Cosette Pharmaceuticals NC Laboratories LLC for prochlorperazine NDA 040058.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC