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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
897 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Venous thromboembolismD054556EFO_0004286I74935703272208
ThromboembolismD013923——936683564202
ThrombosisD013927——1128503670185
Venous thrombosisD020246—I82.40827453851161
Pulmonary embolismD011655EFO_0003827I269930213195
Covid-19D000086382—U07.111525123181
EmbolismD004617——7820152166
NeoplasmsD009369—C80161332142
HemorrhageD006470MP_0001914R5814571732
Atrial fibrillationD001281EFO_0000275I48.0—1451222
Show 115 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101—C90.0243—614
Plasma cell neoplasmsD054219——232—410
Replacement arthroplasty kneeD019645———53——8
Colorectal neoplasmsD015179———24—28
LymphomaD008223—C85.9131—37
Postpartum periodD049590————3—36
Bone fracturesD050723EFO_0003931T14.8—12—25
Stomach neoplasmsD013274EFO_0003897C16—21—14
Female genital neoplasmsD005833———12—14
Viral pneumoniaD011024EFO_0007541J12.9——2—24
Show 75 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———92——111
Ovarian neoplasmsD010051EFO_0003893C56—3——14
Large b-cell lymphoma diffuseD016403—C83.312——13
Pregnancy rateD018873——11——13
B-cell lymphomaD016393——12———2
Cytokine release syndromeD000080424—D89.83—1——12
Catheter-related infectionsD055499———1——12
Iga vasculitisD011695EFO_1000965D69.011——12
StillbirthD050497—P9511———2
Embolism and thrombosisD016769———1——12
Show 35 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Blood platelet disordersD001791——1————1
Balloon angioplasty coronaryD015906EFO_0003951—1————1
Cesarean sectionD002585——1————1
Clear cell sarcomaD018227——1————1
Pseudotumor cerebriD011559EFO_1001132G93.21————1
Intracranial hypertensionD019586EFO_1000992—1————1
Systemic lupus erythematosusD008180EFO_0002690M321————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PainD010146EFO_0003843R52————77
Postoperative complicationsD011183——————66
EcchymosisD004438——————33
Femoral fracturesD005264—S72————33
Drug-related side effects and adverse reactionsD064420—T88.7————22
Heart valve diseasesD006349EFO_0009551I08————22
Length of stayD007902——————22
Connective tissue diseasesD003240EFO_1001986M35————22
Non-st elevated myocardial infarctionD000072658——————22
AgnosiaD000377EFO_0007136F88————22
Show 112 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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6,181 adverse events reported
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