Viewing data from:

PROMETHEGAN

ANDA

PROMETHAZINE HYDROCHLORIDE | A087165 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Promethegan (2023)

Total Spending

$3.2M

Total Claims

21,844

Beneficiaries

14,190

Avg Cost/Unit

$7.35

Spending Trend

$2.3M(2019)→$2.7M(2020)→$2.7M(2021)→$2.6M(2022)→$3.2M(2023)

YoY Change:+4.2%

5yr CAGR:-3.9%

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

API Supply Chain3 active DMFs5 inactive

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

ZYDUS LIFESCIENCES LTDPROMETHAZINE HYDROCHLORIDE USP

DMF 198402006

EMCURE PHARMACEUTICALS LTDPROMETHAZINE HYDROCHLORIDE USP

DMF 258062012

AREVA SYNTHETICS LLCPROMETHAZINE HYDROCHLORIDE USP

DMF 421762025

PHENCHEM INDUSTRIES LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 19741972

MAY AND BAKER LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 94051991

SIGMA ALDRICH IRELAND LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 118881996

WANBURY LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 181732005

IPCA LABORATORIES LTDInactivePROMETHAZINE HYDROCHLORIDE USP

DMF 272412013

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

Products (1)

#001 — 50MG

0 patents0 exclusivities▴

SUPPOSITORY;RECTAL | Approved: Aug 14, 1987

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals NC assumed applicant responsibility for promethazine hydrochloride (Promethegan) NDA 087165, replacing the previously listed entity Cosette.

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 Promethegan (promethazine hydrochloride) NDA 087165.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC