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DEXAMETHASONE SODIUM PHOSPHATE

ANDA

DEXAMETHASONE SODIUM PHOSPHATE | A040069 | BAUSCH AND LOMB INC

1 strength0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Dexamethasone Sodium Phosphate (2023)

Total Spending

$54K

Total Claims

3,389

Beneficiaries

1,646

Avg Cost/Unit

$3.07

Spending Trend

$35K(2019)→$50K(2020)→$43K(2021)→$44K(2022)→$54K(2023)

YoY Change:-18.1%

5yr CAGR:-4.0%

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

API Supply Chain8 active DMFs5 inactive

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

EUROAPI FRANCEDEXAMETHASONE SODIUM PHOSPHATE

DMF 39631980

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCDEXAMETHASONE SODIUM PHOSPHATE USP

DMF 65251986

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDDEXAMETHASONE SODIUM PHOSPHATE

DMF 242152010

CURIA SPAIN SAUDEXAMETHASONE SODIUM PHOSPHATE

DMF 294122015

XIAN GUOKANG RUIJIN PHARMACEUTICAL CO LTDDEXAMETHASONE SODIUM PHOSPHATE

DMF 362692022

HENAN LIHUA PHARMACEUTICAL CO LTDDEXAMETHASONE SODIUM PHOSPHATE

DMF 392592024

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDDEXAMETHASONE SODIUM PHOSPHATE

DMF 417282025

SYMBIOTEC PHARMALAB PRIVATE LIMITEDDEXAMETHASONE SODIUM PHOSPHATE USP

DMF 424652025

DIOSYNTH BVInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 38411980

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 59711985

QUATRUMInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 72251987

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveDEXAMETHASONE SODIUM PHOSPHATE USP

DMF 226472008

TIANJIN TIANYAO PHARMACEUTICALS CO LTDInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 271952013

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

Products (1)

#001 — EQ 0.1% PHOSPHATE

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC, OTIC | Approved: Jul 26, 1996

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

Bausch and Lomb Pharmaceuticals Inc changed its corporate name to Bausch and Lomb Inc for NDA 040069 (dexamethasone sodium phosphate).

Old: BAUSCH AND LOMB PHARMACEUTICALS INC

New: BAUSCH AND LOMB INC

MODIFIEDApplicant7/1/2026

Bausch and Lomb updated its legal entity name from "Bausch and Lomb" to "Bausch and Lomb Inc" for dexamethasone sodium phosphate (NDA 040069).

Old: BAUSCH AND LOMB

New: BAUSCH AND LOMB INC