Viewing data from:

ARIXTRA

NDA

FONDAPARINUX SODIUM | N021345 | MYLAN IRELAND LTD

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Arixtra (2023)

Total Spending

$219K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$181.20

Spending Trend

$644K(2019)→$633K(2020)→$431K(2021)→$333K(2022)→$219K(2023)

YoY Change:-7.0%

5yr CAGR:-2.9%

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

Medicare Part B Spending

CMS physician-administered drug spending for Arixtra (2023)

Total Spending

$2K

Total Claims

140

Beneficiaries

ASP Price

—

HCPCS: J1652 — Injection, fondaparinux sodium, 0.5 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

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

16 letters from Drugs@FDA

Date	Submission	Document
Jan 2, 2025	SUPPL -52	View Letter (PDF)
Aug 26, 2020	SUPPL -43	View Letter (PDF)
Dec 17, 2019	SUPPL -37	View Letter (PDF)
Aug 21, 2017	SUPPL -35	View Letter (PDF)
Jul 17, 2014	SUPPL -32	View Letter (PDF)
Sep 13, 2013	SUPPL -30	View Letter (PDF)
Mar 31, 2010	SUPPL -23	View Letter (PDF)
Dec 31, 2009	SUPPL -25	View Letter (PDF)
Nov 25, 2009	SUPPL -19	View Letter (PDF)
Oct 21, 2008	SUPPL -18	View Letter (PDF)
May 27, 2005	SUPPL -10	View Letter (PDF)
Jun 1, 2004	SUPPL -4	View Letter (PDF)
Jun 1, 2004	SUPPL -5	View Letter (PDF)
Jun 22, 2003	SUPPL -2	View Letter (PDF)
Dec 4, 2002	SUPPL -1	View Letter (PDF)
Dec 7, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 2.5MG/0.5ML (2.5MG/0.5ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Dec 7, 2001

No patent or exclusivity listings for this strength.

#002 — 5MG/0.4ML (5MG/0.4ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: May 28, 2004

#003 — 7.5MG/0.6ML (7.5MG/0.6ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: May 28, 2004

#004 — 10MG/0.8ML (10MG/0.8ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: May 28, 2004