Vascepa, Vazkepa(icosapent)
Icosapent Ethyl, Vascepa, Vazkepa (icosapent) is a small molecule pharmaceutical. Icosapent was first approved as Vascepa on 2012-07-26. It has been approved in Europe to treat dyslipidemias.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Vascepa (generic drugs available since 2020-05-21)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Icosapent ethyl
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VASCEPA | Amarin Corporation | N-202057 RX | 2012-07-26 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| animi-3 | unapproved drug other | 2013-02-06 |
| animi-3 with vitamin d | unapproved drug other | 2011-05-23 |
| bp vit 3 | unapproved drug other | 2023-10-11 |
| c-nate dha | unapproved drug other | 2024-01-22 |
| citranatal assure | unapproved drug other | 2024-01-08 |
| citranatal dha | unapproved drug other | 2020-07-28 |
| citranatal essence | unapproved drug other | 2020-07-07 |
| enbrace hr | unapproved drug other | 2023-12-15 |
| enlyte | unapproved drug other | 2022-07-01 |
| icosapent | ANDA | 2024-01-24 |
Show 7 more
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ICOSAPENT ETHYL, ICOSAPENT ETHYL, TEVA PHARMS USA | |||
| 2023-03-08 | PC | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Icosapent Ethyl, Vascepa, Amarin Pharms | |||
| 9603826 | 2033-06-28 | U-2696 | |
| 9610272 | 2033-06-28 | U-2697 | |
| 9623001 | 2033-06-28 | U-2698 | |
| 9693984 | 2033-06-28 | U-2697 | |
| 9693985 | 2033-06-28 | U-2696 | |
| 9693986 | 2033-06-28 | U-2698 | |
| 9918954 | 2033-06-28 | U-2699 | |
| 10278935 | 2033-06-28 | U-2701 | |
| 10278936 | 2033-06-28 | U-2702 | |
| 10278937 | 2033-06-28 | U-2703 | |
| 10383840 | 2033-06-28 | U-2704 | |
| 10555924 | 2033-06-28 | U-2743 | |
| 10555925 | 2033-06-28 | U-2744 | |
| 10568861 | 2033-06-28 | U-2756 | |
| 10576054 | 2033-06-28 | U-2762 | |
| 10668042 | 2033-06-28 | U-2841 | |
| 10786478 | 2033-06-28 | U-2959, U-2960 | |
| 10792270 | 2033-06-28 | U-2962 | |
| 10894028 | 2033-06-28 | U-3053 | |
| 11000499 | 2033-06-28 | U-3126 | |
| 11116742 | 2033-06-28 | U-3221 | |
| 11298333 | 2033-06-28 | U-3358 | |
| 11369582 | 2033-06-28 | U-2841 | |
| 8410086 | 2030-06-15 | U-2688 | |
| 8455472 | 2030-06-15 | U-2690 | |
| 8669245 | 2030-06-15 | U-2694 | |
| 8710041 | 2030-06-15 | U-2690 | |
| 10842768 | 2030-06-15 | U-2688 | |
| 8298554 | 2030-04-29 | DP | |
| 8445003 | 2030-04-29 | U-1287 | |
| 8445013 | 2030-04-29 | U-1287 | |
| 8454994 | 2030-04-29 | U-2689 | |
| 8501225 | 2030-04-29 | U-1287 | |
| 8551521 | 2030-04-29 | U-1287 | |
| 8563608 | 2030-04-29 | U-1287 | |
| 8617593 | 2030-04-29 | U-1287, U-1478, U-2691 | |
| 8617594 | 2030-04-29 | U-1287 | |
| 8618166 | 2030-04-29 | U-2689 | |
| 8623406 | 2030-04-29 | U-1287, U-1478, U-2692 | |
| 8642077 | 2030-04-29 | U-2693 | |
| 8691871 | 2030-04-29 | U-2689 | |
| 8703185 | 2030-04-29 | U-2691 | |
| 8709475 | 2030-04-29 | U-2689 | |
| 10010517 | 2030-04-29 | U-2690 | |
| 10265287 | 2030-04-29 | U-2700 | |
| 10792267 | 2030-04-29 | U-2961 | |
| 10842766 | 2030-04-29 | U-2997 | |
| 10881632 | 2030-04-29 | U-3052 | |
| 11103477 | 2030-04-29 | U-3209 | |
| 11154526 | 2030-04-29 | U-3240 | |
| 11213504 | 2030-04-29 | U-3292 | |
| 11717504 | 2030-04-29 | U-3669 | |
| 8357677 | 2030-02-09 | U-1287 | |
| 8367652 | 2030-02-09 | U-1287 | |
| 8377920 | 2030-02-09 | U-1287 | |
| 8399446 | 2030-02-09 | U-1287 | |
| 8415335 | 2030-02-09 | U-1287 | |
| 8426399 | 2030-02-09 | U-1287 | |
| 8431560 | 2030-02-09 | U-1287 | |
| 8440650 | 2030-02-09 | U-1287 | |
| 8518929 | 2030-02-09 | U-1287 | |
| 8524698 | 2030-02-09 | U-1287 | |
| 8546372 | 2030-02-09 | U-1287 | |
| 8680144 | 2030-02-09 | U-2695 | |
| 9198892 | 2027-09-25 | U-2706 | |
| 9700537 | 2027-05-31 | U-2707 | |
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
586 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | — | 7 | 5 | 2 | 18 | 30 |
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | 4 | 3 | 10 | 4 | 8 | 28 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | 3 | 5 | 3 | 12 | 22 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 1 | 1 | 1 | 11 | 15 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 1 | 2 | 1 | 9 | 14 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 4 | 3 | 1 | 3 | 10 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 3 | — | 2 | 4 | 9 |
| Child development | D002657 | — | — | — | 2 | 1 | 1 | 5 | 8 |
| Coronary artery disease | D003324 | — | I25.1 | — | 1 | 1 | 5 | 1 | 8 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 2 | — | 1 | 4 | 7 |
Show 45 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | 1 | 2 | — | 18 | 26 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 5 | 4 | 1 | — | 7 | 16 |
| Depression | D003863 | — | F33.9 | — | 4 | 6 | — | 4 | 13 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 1 | 6 | — | 4 | 12 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 1 | 3 | — | 6 | 10 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 1 | 2 | 2 | — | 6 | 9 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | 1 | — | 1 | — | 6 | 8 |
| Asthma | D001249 | EFO_0000270 | J45 | 1 | 1 | 1 | — | 4 | 7 |
| Fatty liver | D005234 | EFO_0003934 | — | 2 | 3 | 2 | — | 1 | 7 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 1 | 1 | — | 4 | 6 |
Show 47 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyslipidemias | D050171 | HP_0003119 | — | 1 | 1 | — | — | 3 | 5 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | 1 | — | — | 3 | 4 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | 3 | — | — | 1 | 4 |
| Pregnancy rate | D018873 | — | — | — | 1 | — | — | 2 | 3 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 1 | — | — | 1 | 2 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | 1 | — | — | — | 2 |
| Behavior | D001519 | GO_0007610 | STY/T053 | — | 1 | — | — | 1 | 2 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | 2 | — | — | — | 2 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | 1 | — | — | 1 | 2 |
| Necrotizing enterocolitis | D020345 | EFO_0003928 | K55.3 | 1 | 1 | — | — | 1 | 2 |
Show 38 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | HP_0000855 | E88.819 | 1 | — | — | — | 4 | 5 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | 1 | — | — | — | 3 | 4 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 1 | — | — | — | 3 | 4 |
| Pregnancy-induced hypertension | D046110 | — | O13 | 1 | — | — | — | 2 | 3 |
| Gestational diabetes | D016640 | HP_0009800 | O24.4 | 1 | — | — | — | 2 | 3 |
| Brain concussion | D001924 | — | S06.0 | 1 | — | — | — | 1 | 2 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | 1 | — | — | — | 1 | 2 |
| Healthy diet | D000072001 | — | — | 1 | — | — | — | 1 | 2 |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | — | — | — | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | — | — | — | — | 1 |
Show 5 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Phenylketonurias | D010661 | — | E70.0 | — | — | — | — | 7 | 7 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 5 | 5 |
| Affect | D000339 | — | — | — | — | — | — | 4 | 4 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 3 | 3 |
| Muscular atrophy | D009133 | HP_0003202 | — | — | — | — | — | 3 | 3 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | — | 2 | 2 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | — | 2 | 2 |
| Bone density | D015519 | EFO_0003923 | M85 | — | — | — | — | 2 | 2 |
| Cerebrovascular circulation | D002560 | — | — | — | — | — | — | 2 | 2 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | — | 2 | 2 |
Show 74 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Icosapent |
| INN | icosapent |
| Description | All-cis-5,8,11,14,17-icosapentaenoic acid is an icosapentaenoic acid having five cis-double bonds at positions 5, 8, 11, 14 and 17. It has a role as a nutraceutical, a micronutrient, an antineoplastic agent, an antidepressant, a Daphnia galeata metabolite, a mouse metabolite, an anticholesteremic drug and a fungal metabolite. It is an icosapentaenoic acid and an omega-3 fatty acid. It is a conjugate acid of an all-cis-5,8,11,14,17-icosapentaenoate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 10417-94-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL460026 |
| ChEBI ID | 28364 |
| PubChem CID | 446284 |
| DrugBank | DB00159 |
| UNII ID | AAN7QOV9EA (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Icosapent
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 30,815 documents
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Safety
Black-box Warning
Black-box warning for: Citranatal assure, Citranatal dha, Citranatal essence, Enlyte, Nestabs dha, Pnv-omega, Pre-tabs dha, Prenate essential, Tristart dha
Adverse Events
Top Adverse Reactions
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2,803 adverse events reported
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