Viewing data from:

FRAGMIN

NDA

DALTEPARIN SODIUM | N020287 | PFIZER INC

12 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 Fragmin (2023)

Total Spending

$2.2M

Total Claims

493

Beneficiaries

Avg Cost/Unit

$263.92

Spending Trend

$4.1M(2019)→$3.0M(2020)→$2.4M(2021)→$1.9M(2022)→$2.2M(2023)

YoY Change:+22.2%

5yr CAGR:+9.5%

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 Fragmin (2023)

Total Spending

$17K

Total Claims

248

Beneficiaries

ASP Price

—

HCPCS: J1645 — Injection, dalteparin sodium, per 2500 iu

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

API Supply Chain2 active DMFs5 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHANGZHOU QIANHONG BIO PHARMA CO LTDDALTEPARIN SODIUM

DMF 205412007

GLAND PHARMA LTDDALTEPARIN SODIUM PH.EUR.

DMF 255562011

RELIABLE BIOPHARMACEUTICAL CORPInactiveDALTEPARIN SODIUM

DMF 190382005

OPOCRIN SPAInactiveDALTEPARIN SODIUM BULK

DMF 196582006

DONGYING TIANDONG PHARMACEUTICAL CO LTDInactiveDALTEPARIN SODIUM USP

DMF 209052007

ALP PHARM BEIJING CO LTDInactiveDALTEPARIN SODIUM (DRUG SUBSTANCE, NON-STERILE)

DMF 219502008

HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO LTDInactiveDALTEPARIN SODIUM

DMF 291542015

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

Approval Letters

25 letters from Drugs@FDA

Date	Submission	Document
Oct 28, 2024	SUPPL -81	View Letter (PDF)
Oct 16, 2024	SUPPL -80	View Letter (PDF)
Dec 8, 2020	SUPPL -76	View Letter (PDF)
Jun 30, 2020	SUPPL -74	View Letter (PDF)
Jun 30, 2020	SUPPL -75	View Letter (PDF)
May 17, 2019	SUPPL -72	View Letter (PDF)
May 17, 2017	SUPPL -69	View Letter (PDF)
Aug 4, 2016	SUPPL -67	View Letter (PDF)
Oct 1, 2015	SUPPL -63	View Letter (PDF)
Jan 27, 2015	SUPPL -62	View Letter (PDF)
Oct 26, 2010	SUPPL -50	View Letter (PDF)
Jan 5, 2010	SUPPL -49	View Letter (PDF)
May 7, 2007	SUPPL -35	View Letter (PDF)
Apr 29, 2004	SUPPL -34	View Letter (PDF)
Dec 16, 2003	SUPPL -32	View Letter (PDF)
Jul 6, 2003	SUPPL -31	View Letter (PDF)
Mar 10, 2003	SUPPL -11	View Letter (PDF)
Nov 19, 2002	SUPPL -29	View Letter (PDF)
Nov 1, 2002	SUPPL -27	View Letter (PDF)
Apr 4, 2002	SUPPL -23	View Letter (PDF)
Apr 4, 2002	SUPPL -21	View Letter (PDF)
Apr 4, 2002	SUPPL -22	View Letter (PDF)
Aug 3, 2000	SUPPL -18	View Letter (PDF)
May 25, 1999	SUPPL -10	View Letter (PDF)
Mar 30, 1999	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (12)

Sort:

#001 — 2,500IU/0.2ML (12,500IU/ML)

RLD

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Dec 22, 1994

No patent or exclusivity listings for this strength.

#002 — 10,000IU/0.4ML (25,000IU/ML)

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: May 1, 2007

#003 — 5,000IU/0.2ML (25,000IU/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Mar 18, 1996

#004 — 10,000IU/ML (10,000IU/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Jan 30, 1998

#005 — 7,500IU/0.3ML (25,000IU/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Apr 4, 2002

#006 — 95,000IU/3.8ML (25,000IU/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Apr 4, 2002

#007 — 95,000IU/9.5ML (10,000IU/ML)

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Apr 4, 2002

#008 — 7,500 IU/0.75ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 4, 2002

#009 — 12,500IU/0.5ML (25,000IU/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: May 1, 2007

#010 — 15,000IU/0.6ML (25,000IU/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: May 1, 2007

#011 — 18,000IU/0.72ML (25,000IU/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: May 1, 2007

#012 — 10,000IU/4ML (2,500IU/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Mar 15, 2022