Drug
Who makes icosapent ethyl?
18 companies list icosapent ethyl as a human prescription drug, including under the names Vascepa. Forms: capsule; capsule, liquid filled. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing icosapent ethyl
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | capsule; capsule, liquid filled | ANDA, NDAANDA209457, ANDA209499, ANDA216811 | 8 | 1 |
| Amarin Pharma Inc. | capsule | NDANDA202057 | 4 | 0 |
| Epic Laboratories, LLCUnited States | capsule, liquid filled | ANDAANDA217919 | 3 | 3 |
| Dr. Reddy's Laboratories LimitedIndia | capsule | ANDAANDA209499 | 2 | 15 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule, liquid filled | ANDAANDA209525 | 2 | 6 |
| Hikma Pharmaceuticals USA Inc.United States | capsule | ANDAANDA209457 | 2 | 4 |
| SOFTGEL HEALTHCARE PRIVATE LIMITEDIndia | capsule | ANDAANDA217656 | 2 | 2 |
| Amneal Ireland LimitedIreland | capsule | ANDAANDA217844 | 2 | 1 |
| Camber Pharmaceuticals, Inc.United States | capsule | ANDAANDA216811 | 2 | 1 |
| XLCare Pharmaceuticals Inc.United States | capsule | ANDAANDA216811 | 2 | 1 |
| Zydus Pharmaceuticals USA Inc.India | capsule | ANDAANDA217656 | 2 | 1 |
| Northstar Rx, LLC, | capsule | ANDAANDA209457, ANDA216811 | 2 | 0 |
| Apotex Inc.Canada | capsule | ANDAANDA209437 | 1 | 6 |
| Aurobindo Pharma LimitedIndia | capsule | ANDAANDA218949 | 1 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule | ANDAANDA209437 | 1 | 5 |
| Qilu Pharmaceutical Co., Ltd.China | capsule | ANDAANDA218899 | 1 | 5 |
| Golden State Medical Supply Inc.United States | capsule | ANDAANDA209437 | 1 | 1 |
| Vitruvias Therapeutics, Inc. | capsule | ANDAANDA219156 | 1 | 0 |
Bulk ingredient listings
- AK BIOPHARM CO., LTD.South Korea · 1 NDC
- BASF AS avd SandefjordNorway · 1 NDC
- BASF Pharma (Callanish) Limited · 1 NDC
- Chemport Inc.South Korea · 1 NDC
- FinorgaFrance · 1 NDC
- Huatai Pharma IncChina · 1 NDC
Orange Book patents
61 unexpired patents list icosapent ethyl as the active ingredient, expiring between May 2027 and Jun 2033. Application holder: AMARIN PHARMACEUTICALS IRELAND LTD.
Enquiry
Common questions
- Who makes icosapent ethyl?
- 18 companies list icosapent ethyl as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Amarin Pharma Inc., Epic Laboratories, LLC, Dr. Reddy's Laboratories Limited, Teva Pharmaceutical Industries Ltd.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Vascepa?
- 17 companies list icosapent ethyl under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies icosapent ethyl active ingredient?
- 6 companies list icosapent ethyl as a bulk ingredient, including AK BIOPHARM CO., LTD., BASF AS avd Sandefjord, BASF Pharma (Callanish) Limited, Chemport Inc..