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FOSINOPRIL SODIUM

ANDA

FOSINOPRIL SODIUM | A076139 | TEVA PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Fosinopril Sodium (2023)

Total Spending

$5.9M

Total Claims

211,268

Beneficiaries

50,736

Avg Cost/Unit

$0.32

Spending Trend

$6.7M(2019)→$5.9M(2020)→$5.9M(2021)→$5.4M(2022)→$5.9M(2023)

YoY Change:+18.2%

5yr CAGR:+2.9%

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

API Supply Chain3 active DMFs3 inactive

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

HETERO DRUGS LTDFOSINOPRIL SODIUM

DMF 160082002

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDFOSINOPRIL SODIUM USP

DMF 178052004

APITORIA PHARMA PRIVATE LTDFOSINOPRIL SODIUM USP

DMF 197112006

AMINO CHEMICALS LTDInactiveFOSINOPRIL SODIUM

DMF 153262001

QUIMICA SINTETICA SAInactiveFOSINOPRIL SODIUM

DMF 159342002

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveFOSINOPRIL SODIUM USP (NON-STERILE BULK)

DMF 163212002

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 27, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 25, 2003

No patent or exclusivity listings for this strength.

#002 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 25, 2003

#003 — 40MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 25, 2003