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Drug ReportsDalteparin
Dalteparin sodium
Fragmin (dalteparin sodium) is an oligosaccharide pharmaceutical. Dalteparin sodium was first approved as Fragmin on 1994-12-22. It is used to treat myocardial infarction, postoperative complications, pulmonary embolism, thromboembolism, and thrombophlebitis amongst others in the USA. The pharmaceutical is active against antithrombin-III.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Fragmin (discontinued: Fragmin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dalteparin sodium
Tradename
Company
Number
Date
Products
FRAGMINPfizerN-020287 RX1994-12-22
9 products, RLD
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
fragminNew Drug Application2025-09-30
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
B01: Antithrombotic agents
B01A: Antithrombotic agents
B01AB: Heparin group antithrombotic drugs
B01AB04: Dalteparin
HCPCS
Code
Description
J1645
Injection, dalteparin sodium, per 2500 iu
Clinical
Clinical Trials
854 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ThromboembolismD013923938723769215
Venous thromboembolismD054556EFO_0004286I74934683062194
ThrombosisD0139271130523772191
Venous thrombosisD020246I82.40827443646153
Pulmonary embolismD011655EFO_0003827I269929212588
Covid-19D000086382U07.111525123181
EmbolismD0046177822162371
NeoplasmsD009369C80161332142
HemorrhageD006470MP_0001914R5813471832
SyndromeD0135774754725
Show 105 more
Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients82110
Ovarian neoplasmsD010051EFO_0003893C56415
Large b-cell lymphoma diffuseD016403C83.31213
Ovarian epithelial carcinomaD00007721633
Pregnancy rateD0188731113
B-cell lymphomaD016393122
Cytokine release syndromeD000080424D89.83112
Staphylococcal infectionsD013203A49.01112
Catheter-related infectionsD055499112
Iga vasculitisD011695EFO_1000965D69.01112
Show 39 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Blood platelet disordersD00179111
Balloon angioplasty coronaryD015906EFO_000395111
Cesarean sectionD00258511
StillbirthD050497P9511
Clear cell sarcomaD01822711
Pseudotumor cerebriD011559EFO_1001132G93.211
Intracranial hypertensionD019586EFO_100099211
Systemic lupus erythematosusD008180EFO_0002690M3211
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PainD010146EFO_0003843R5277
Postoperative complicationsD01118366
EcchymosisD00443833
Femoral fracturesD005264S7233
Drug-related side effects and adverse reactionsD064420T88.722
Heart valve diseasesD006349EFO_0009551I0822
Length of stayD00790222
Connective tissue diseasesD003240EFO_1001986M3522
Non-st elevated myocardial infarctionD00007265822
Artificial respirationD01212122
Show 105 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDalteparin sodium
INNdalteparin sodium
Description
Dalteparin is a low molecular weight heparin. It is marketed as Fragmin. Like other low molecular weight heparins, dalteparin is used for prophylaxis or treatment of deep vein thrombosis and pulmonary embolism to reduce the risk of a stroke or heart attack. Dalteparin acts by potentiating the activity of antithrombin III, inhibiting formation of both Factor Xa and thrombin. It is normally administered by self-injection.
Classification
Oligosaccharide
Drug classheparin derivatives and low molecular weight (or depolymerized) heparins
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID
RxCUI67109
ChEMBL IDCHEMBL1201460
ChEBI ID
PubChem CID
DrugBankDB06779
UNII ID12M44VTJ7B (ChemIDplus, GSRS)
Target
Agency Approved
SERPINC1
SERPINC1
Organism
Homo sapiens
Gene name
SERPINC1
Gene synonyms
AT3
NCBI Gene ID
Protein name
antithrombin-III
Protein synonyms
serine (or cysteine) proteinase inhibitor, clade C (antithrombin), member 1, Serpin C1, serpin peptidase inhibitor clade C member 1, serpin peptidase inhibitor, clade C (antithrombin), member 1
Uniprot ID
Mouse ortholog
Serpinc1 (11905)
antithrombin-III (P32261)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
Fragmin Pfizer
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Estimated US medical usage
Dalteparin sodium
+
Dalteparin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
No data
Safety
Black-box Warning
Black-box warning for: Fragmin
Adverse Events
Top Adverse Reactions
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5,898 adverse events reported
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