NDAINJECTIONINJECTABLE
Approved
Dec 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
6/8 — Strong
FRAGMIN (dalteparin sodium) by Pfizer is properties. Approved for non-q-wave myocardial infarction, concurrently administered with aspirin therapy [see ], deep vein thrombosis (dvt) and 2 more indications. First approved in 1994.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FRAGMIN (dalteparin sodium) is a low-molecular-weight heparin approved in 1994 that prevents and treats blood clots by enhancing Factor Xa and thrombin inhibition through antithrombin. It is indicated for non-Q-wave MI, DVT/PE prevention in hip replacement surgery, and VTE recurrence reduction in pediatric patients. The drug is administered via subcutaneous injection and works preferentially on Factor Xa while minimally affecting APTT.
$0.002BPart D
LOE ApproachingFRAGMIN is in LOE-approaching phase with modest Part D spending ($2M in 2023), indicating a mature, stable product with limited commercial growth potential and smaller dedicated team resources.
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 (3)
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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.