Viewing data from:

FONDAPARINUX SODIUM

ANDA

FONDAPARINUX SODIUM | A091316 | DR REDDYS LABORATORIES LTD

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ARIXTRA(TE code: AP)

Medicare Part D Spending

CMS annual spending data for Fondaparinux Sodium (2023)

Total Spending

$19.1M

Total Claims

13,028

Beneficiaries

2,688

Avg Cost/Unit

$89.56

Spending Trend

$24.4M(2019)→$21.7M(2020)→$18.1M(2021)→$19.9M(2022)→$19.1M(2023)

YoY Change:+0.1%

5yr CAGR:-1.6%

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

API Supply Chain13 active DMFs4 inactive

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

DR REDDYS LABORATORIES LTDFONDAPARINUX SODIUM USP

DMF 225792009

JIANGSU HENGRUI PHARMACEUTICALS CO LTDFONDAPARINUX SODIUM USP, NON-STERILE BULK DRUG SUBSTANCE

DMF 273362013

FORMOSA LABORATORIES INCFONDAPARINUX SODIUM

DMF 274752013

SCINOPHARM TAIWAN LTDFONDAPARINUX SODIUM USP

DMF 275632013

APITORIA PHARMA PRIVATE LTDFONDAPARINUX SODIUM USP

DMF 278732014

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDFONDAPARINUX SODIUM

DMF 285842014

ASPEN OSS BVFONDAPARINUX SODIUM USP

DMF 287622014

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDFONDAPARINUX SODIUM (NON-STERILE, API)

DMF 307672016

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDFONDAPARINUX SODIUM

DMF 348282020

WISDOM PHARMACEUTICAL CO LTDFONDAPARINUX SODIUM

DMF 374992022

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDFONDAPARINUX SODIUM USP

DMF 377292022

SICHUAN AUPONE PHARMACEUTICAL CO LTDFONDAPARINUX SODIUM

DMF 384282023

NEWLAND PHARMACEUTICAL CO LTDFONDAPARINUX SODIUM

DMF 418832025

GLAXO GROUP LTD DBA GLAXOSMITHKLINEInactiveFONDAPARINUX SODIUM

DMF 152572001

SANOFI CHIMIEInactiveFONDAPARINUX SODIUM

DMF 152592001

MYLAN LABORATORIES LTDInactiveFONDAPARINUX SODIUM USP

DMF 238632010

RELIABLE BIOPHARMACEUTICAL CORPInactiveFONDAPARINUX SODIUM

DMF 250932011

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 28, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 2.5MG/0.5ML (2.5MG/0.5ML)

0 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Jul 11, 2011

No patent or exclusivity listings for this strength.

#002 — 5MG/0.4ML (5MG/0.4ML)

0 patents0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Jul 11, 2011

#003 — 7.5MG/0.6ML (7.5MG/0.6ML)

0 patents0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Jul 11, 2011

#004 — 10MG/0.8ML (10MG/0.8ML)

0 patents0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Jul 11, 2011