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DANTROLENE SODIUM

ANDA

DANTROLENE SODIUM | A076686 | ELITE LABORATORIES INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DANTRIUM(TE code: AB)

Medicare Part D Spending

CMS annual spending data for Dantrolene Sodium (2023)

Total Spending

$4.0M

Total Claims

41,777

Beneficiaries

6,406

Avg Cost/Unit

$0.87

Spending Trend

$4.9M(2019)→$4.9M(2020)→$4.4M(2021)→$4.2M(2022)→$4.0M(2023)

YoY Change:-1.0%

5yr CAGR:-3.0%

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

API Supply Chain6 active DMFs1 inactive

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

JINAN JINDA PHARMACEUTICAL CHEMISTRY CO LTDDANTROLENE SODIUM NON-STERILE BULK DRUG SUBSTANCE

DMF 151672000

SCINOPHARM TAIWAN LTDDANTROLENE SODIUM USP

DMF 161182002

HAS HEALTHCARE ADVANCED SYNTHESIS SADANTROLENE SODIUM DRUG SUBSTANCE

DMF 194982006

VERANOVA LPDANTROLENE SODIUM (DTE)

DMF 207792007

BIOPHORE INDIA PHARMACEUTICALS PVT LTDDANTROLENE SODIUM

DMF 338452019

GLAND PHARMA LTDDANTROLENE SODIUM

DMF 393052024

FDC LTDInactiveDANTROLENE SODIUM

DMF 174462004

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

Products (3)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 24, 2005

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 24, 2005

#003 — 100MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 24, 2005