NDAINJECTIONINJECTABLE
Approved
Dec 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
5/8 — Partial
FRAGMIN (dalteparin sodium) by Pfizer is properties. First approved in 1994.
Drug data last refreshed 4h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FRAGMIN (dalteparin sodium) is a low-molecular-weight heparin administered by injection that prevents and treats blood clots by enhancing Factor Xa inhibition through antithrombin. It is indicated for deep vein thrombosis, venous thromboembolism, superficial thrombophlebitis, and related thromboembolic conditions, including those in diabetic patients with foot ulcers or renal insufficiency. The mechanism preferentially inhibits coagulation Factor Xa while minimally affecting APTT.
$0.002BPart D
LOE ApproachingDeclining
With LOE approaching and only 493 Part D claims in 2023, the FRAGMIN brand team is likely consolidating to defend existing market share against newer anticoagulants rather than pursuing expansion.
Mechanism of Action
properties. It acts by enhancing the inhibition of Factor Xa and thrombin by antithrombin. In humans, dalteparin potentiates preferentially the inhibition of coagulation Factor Xa, while only slightly affecting the activated partial thromboplastin time (APTT).
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Use Of Fragmin In Hemodialysis
Started Oct 2013
152 enrolled
Chronic Renal Failure
An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®
Started Mar 2010
503 enrolled
Venous Thromboembolism
Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
Started Aug 2009
38 enrolled
Venous Thromboembolism
The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)
Started Oct 2008
62 enrolled
Diabetic Foot Ulcer
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
Started Apr 2008
276 enrolled
Diabetic Foot Ulcer
Worked on FRAGMIN at Pfizer? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.