Prescription medicine
Icosapent Brand names: Vascepa
Icosapent (Vascepa) is a prescription medicine with an FDA approval on record since 2012. FDA's NDC Directory lists it from 18 generic labelers, and pharmacies paid $0.441 per icosapent ethyl 1 gram capsule in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the icosapent FDA label on DailyMed (effective July 9, 2026, Hikma Pharmaceuticals USA Inc.); the NDA 202057 record on Drugs@FDA; every icosapent label on DailyMed.
Highlights of the record
FDA label of July 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageIcosapent ethyl is indicated:
as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Forms and strengths
- 0.5 g
- 1 g
- 500 mg
- 1000 mg
- 1 g/g
Capsule; liquid-filled capsule.
On the market
- Earliest approval on file
- July 26, 2012 Vascepa, Amarin Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first May 21, 2020; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 19 of which 18 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- June 28, 2033 Vascepa capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.441 per capsule Icosapent ethyl 1 gram capsule
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 3 since 2025 0 Class I among all firms' recalls; latest March 9, 2026
- FAERS reports
- 8,464 through July 30, 2026
What is icosapent used for?
From the label: indications and usageIcosapent ethyl is indicated:
as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Limitations of Use The effect of icosapent ethyl on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Icosapent ethyl capsules are an ethyl ester of eicosapentaenoic acid (EPA) indicated:
as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. ( 1 ) Limitations of Use:
The effect of icosapent ethyl on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Conditions named in the indications of icosapent's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Icosapent Ethyl), Hikma Pharmaceuticals USA Inc., effective July 9, 2026 (SPL set e3d38d1d-fbe7-413d-849a-675e7dfa9b0a), via openFDA; the full label on DailyMed
Is there a generic for icosapent (Vascepa)?
The FDA approved the first generic icosapent on May 21, 2020. 12 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists icosapent from 18 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 61 patents for Vascepa capsules, the last expiring on June 28, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2020 first generic approved
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for icosapent (Vascepa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.441 per Icosapent ethyl 1 gram capsule, down 14% from $0.515 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Icosapent ethyl 1 gram capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Icosapent ethyl 0.5 g capsule | Generic | $0.334 per capsule | $10.03 | -41% |
| Icosapent ethyl 1 gram capsule | Generic | $0.441 per capsule | $13.22 | -14% |
| Icosapent ethyl 500 mg capsule | Generic | $0.334 per capsule | $10.03 | -41% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is icosapent in shortage?
No icosapent presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated April 1, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Icosapent Ethyl, Capsule, 1 g (NDC 60429-005-12) | Apotex Corp. | To Be Discontinued | April 1, 2026 |
| Icosapent Ethyl, Capsule, 1 g (NDC 61474-9711-1) | Apotex Corp. | To Be Discontinued | April 1, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has icosapent been recalled?
The FDA's Enforcement Report lists 3 recalls naming icosapent since 2025: 0 Class I (the most serious), 3 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 9, 2026 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. |
| December 30, 2025 | Class II | Zydus Pharmaceuticals (USA) Inc | Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules |
| May 30, 2025 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the icosapent label say about other medicines?
The icosapent label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | warnings and precautions | The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin. |
| Clopidogrel | warnings and precautions | The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin. |
| Warfarin | warnings and precautions | The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin. |
Source: FDA drug label (Icosapent Ethyl), Hikma Pharmaceuticals USA Inc., effective July 9, 2026 (SPL set e3d38d1d-fbe7-413d-849a-675e7dfa9b0a), via openFDA; the full label on DailyMed
What do FAERS reports show for icosapent?
The FDA Adverse Event Reporting System holds 8,464 reports that list icosapent among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 542 are coded as a death and 1,571 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as icosapent?
1 other medicine is given the same way (oral) and in the same FDA class as icosapent or labeled mainly for the same use (high triglycerides), the same class first. High triglycerides lists all 11 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Omega 3-acid ethyl esters | High triglycerides | 17 labelers | $0.171 per capsule 3 ethyl esters 1 g capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Icosapent side effects
- the label's list beside FAERS reports
- Icosapent shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other