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NISOLDIPINE

ANDA

NISOLDIPINE | A079051 | MYLAN PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Nisoldipine (2023)

Total Spending

$4.9M

Total Claims

12,372

Beneficiaries

2,920

Avg Cost/Unit

$5.15

Spending Trend

$7.8M(2019)→$7.3M(2020)→$6.3M(2021)→$5.6M(2022)→$4.9M(2023)

YoY Change:-3.6%

5yr CAGR:+0.6%

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

API Supply Chain7 active DMFs

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

BAYER AGNISOLDIPINE

DMF 101671993

LUSOCHIMICA SPANISOLDIPINE

DMF 143371999

ERREGIERRE SPANISOLDIPINE

DMF 162152002

PH HEALTH LTDNISOLDIPINE NON STERILE BULK DRUG SUBSTANCE

DMF 211062007

ORCHID PHARMA LTDNISOLDIPINE (NON-STERILE BULK API)

DMF 225392009

ALEMBIC PHARMACEUTICALS LTDNISOLDIPINE

DMF 253652011

EMCURE PHARMACEUTICALS LTDNISOLDIPINE

DMF 257502012

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 31, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 20MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 25, 2008

No patent or exclusivity listings for this strength.

#002 — 30MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 25, 2008

#003 — 40MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 25, 2008