ICOSAPENT ETHYL | A209457 | HIKMA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Amarin Pharma, Inc. et al v. Hikma Pharmaceuticals USA Inc., et al. 3 patentsANDA 209457icosapent ethyl (ethyl icosapentate, ethyl eicosapentaenoate) | D. Del. | 2020-11-30 | Terminated 2022-08-30 | — |
Amarin Pharma Inc. et al v. Hikma Pharmaceuticals USA Inc. et al 14 patentsANDA 209457icosapent ethyl | D. Nev. | 2016-10-31 | Terminated 2020-03-30 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Medical Research Collaborative, LLC FDA-2019-P-3424 · 3 docket documents Medical Research Collaborative, LLC filed this citizen petition on July 16, 2019, requesting that the FDA delay approval of the supplemental New Drug Application (sNDA) for icosapent ethyl (Vascepa) until drug-drug interaction studies demonstrate that mineral oil in the placebo does not attenuate th | 505(q) Stay Request | 2019-07-17 | Denied | Medical Research Collaborative, LLC |
Citizen Petition from Medical Research Collaborative LLC FDA-2019-P-3265 · 3 docket documents Medical Research Collaborative, LLC filed this citizen petition on July 8, 2019, requesting that the FDA Commissioner remove Amarin Corp.'s U.S. Patent No. 8,188,146 from the Orange Book because the patent does not claim an approved method of using icosapent ethyl (Vascepa) for its FDA-approved indi | 505(q) | 2019-07-09 | Open | Medical Research Collaborative LLC |
Citizen Petition from Medical Research Collaborative, LLC FDA-2019-P-3156 · 3 docket documents Medical Research Collaborative, LLC filed this citizen petition under 21 C.F.R. § 10.30 and 10.31 requesting that the FDA Commissioner delay approval of the supplemental New Drug Application for icosapent ethyl (Vascepa) until drug-drug interaction studies demonstrate that mineral oil in the REDUCE- | 505(q) Stay Request | 2019-07-01 | Withdrawn | Medical Research Collaborative, LLC |
Citizen Petition from Amarin Pharma Inc. FDA-2014-P-0878 · 3 docket documents Amarin Pharma Inc. filed this citizen petition on June 24, 2014, requesting that the FDA impose specific bioequivalence testing requirements on any abbreviated new drug application (ANDA) listing Vascepa (icosapent ethyl) as the referenced listed drug, including requirements that generic products co | 505(q) | 2014-08-26 | Denied | Amarin Pharma Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.4469
per ea
Lowest NADAC/Unit
$0.3522
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00054050823ICOSAPENT ETHYL 1 GRAM CAPSULE | $0.4469 | EA | Generic | — | 2026-06-17 |
| 72603012901ICOSAPENT ETHYL 1 GRAM CAPSULE | $0.4469 | EA | Generic | — | 2026-06-17 |
| 00054062127ICOSAPENT ETHYL 0.5 GM CAPSULE | $0.3522 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.