icosapent ethyl · Amarin Pharms · NDA 202057
Vascepa
Blocked by patent: US 10278935, US 10278936, US 10278937, US 10383840, US 10555924, US 10555925, US 10568861, US 10576054, US 10668042, US 10786478, US 10792270, US 10894028, US 11000499, US 11116742, US 11298333, US 11369582, US 9603826, US 9610272, US 9623001, US 9693984, US 9693985, US 9693986, US 9918954. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
FDA has approved 1 generic application (ANDA) for Vascepa, though its earliest generic-entry date is 28 Jun 2033 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 61 unexpired
66 Orange Book listing rows for 61 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10278935 | use U-2701 · sets the listed date | 28 Jun 2033 |
| US 10278936 | use U-2702 · sets the listed date | 28 Jun 2033 |
| US 10278937 | use U-2703 · sets the listed date | 28 Jun 2033 |
| US 10383840 | use U-2704 · sets the listed date | 28 Jun 2033 |
| US 10555924 | use U-2743 · sets the listed date | 28 Jun 2033 |
| US 10555925 | use U-2744 · sets the listed date | 28 Jun 2033 |
| US 10568861 | use U-2756 · sets the listed date | 28 Jun 2033 |
| US 10576054 | use U-2762 · sets the listed date | 28 Jun 2033 |
| US 10668042 | use U-2841 · sets the listed date | 28 Jun 2033 |
| US 10786478 | use U-2959, U-2960 | 28 Jun 2033 |
| US 10786478 listing row | use U-2959 · sets the listed date | 28 Jun 2033 |
| US 10786478 listing row | use U-2960 · sets the listed date | 28 Jun 2033 |
| US 10792270 | use U-2962 · sets the listed date | 28 Jun 2033 |
| US 10894028 | use U-3053 · sets the listed date | 28 Jun 2033 |
| US 11000499 | use U-3126 · sets the listed date | 28 Jun 2033 |
| US 11116742 | use U-3221 · sets the listed date | 28 Jun 2033 |
| US 11298333 | use U-3358 · sets the listed date | 28 Jun 2033 |
| US 11369582 | use U-2841 · sets the listed date | 28 Jun 2033 |
| US 9603826 | use U-2696 · sets the listed date | 28 Jun 2033 |
| US 9610272 | use U-2697 · sets the listed date | 28 Jun 2033 |
| US 9623001 | use U-2698 · sets the listed date | 28 Jun 2033 |
| US 9693984 | use U-2697 · sets the listed date | 28 Jun 2033 |
| US 9693985 | use U-2696 · sets the listed date | 28 Jun 2033 |
| US 9693986 | use U-2698 · sets the listed date | 28 Jun 2033 |
| US 9918954 | use U-2699 · sets the listed date | 28 Jun 2033 |
| US 10842768 | use U-2688 | 15 Jun 2030 |
| US 8410086 | use U-2688 | 15 Jun 2030 |
| US 8455472 | use U-2690 | 15 Jun 2030 |
| US 8669245 | use U-2694 | 15 Jun 2030 |
| US 8710041 | use U-2690 | 15 Jun 2030 |
| US 10010517 | use U-2690 | 29 Apr 2030 |
| US 10265287 | use U-2700 | 29 Apr 2030 |
| US 10792267 | use U-2961 | 29 Apr 2030 |
| US 10842766 | use U-2997 | 29 Apr 2030 |
| US 10881632 | use U-3052 | 29 Apr 2030 |
| US 11103477 | use U-3209 | 29 Apr 2030 |
| US 11154526 | use U-3240 | 29 Apr 2030 |
| US 11213504 | use U-3292 | 29 Apr 2030 |
| US 11717504 | use U-3669 | 29 Apr 2030 |
| US 8298554 | drug product | 29 Apr 2030 |
| US 8445003 | use U-1287 | 29 Apr 2030 |
| US 8445013 | use U-1287 | 29 Apr 2030 |
| US 8454994 | use U-2689 | 29 Apr 2030 |
| US 8501225 | use U-1287 | 29 Apr 2030 |
| US 8563608 | use U-1287 | 29 Apr 2030 |
| US 8617593 | use U-1287, U-1478, U-2691 | 29 Apr 2030 |
| US 8617593 listing row | use U-1287 | 29 Apr 2030 |
| US 8617593 listing row | use U-1478 | 29 Apr 2030 |
| US 8617593 listing row | use U-2691 | 29 Apr 2030 |
| US 8617594 | use U-1287 | 29 Apr 2030 |
| US 8618166 | use U-2689 | 29 Apr 2030 |
| US 8623406 | use U-1287, U-1478, U-2692 | 29 Apr 2030 |
| US 8623406 listing row | use U-1287 | 29 Apr 2030 |
| US 8623406 listing row | use U-1478 | 29 Apr 2030 |
| US 8623406 listing row | use U-2692 | 29 Apr 2030 |
| US 8642077 | use U-2693 | 29 Apr 2030 |
| US 8691871 | use U-2689 | 29 Apr 2030 |
| US 8703185 | use U-2691 | 29 Apr 2030 |
| US 8709475 | use U-2689 | 29 Apr 2030 |
| US 12171738 | use U-4105 | 9 Feb 2030 |
| US 8399446 | use U-1287 | 9 Feb 2030 |
| US 8415335 | use U-1287 | 9 Feb 2030 |
| US 8426399 | use U-1287 | 9 Feb 2030 |
| US 8518929 | use U-1287 | 9 Feb 2030 |
| US 8524698 | use U-1287 | 9 Feb 2030 |
| US 8546372 | use U-1287 | 9 Feb 2030 |
| US 8680144 | use U-2695 | 9 Feb 2030 |
| US 9198892 | use U-2706 | 25 Sep 2027 |
| US 9700537 | use U-2707 | 31 May 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 218949, Aurobindo Pharma Ltd · 202057-001Approved 24 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202057 · 001 · RLD | capsule, oral | 1GM | 28 Jun 2033 |
| 202057 · 002 · RLD | capsule, oral | 500MG | 28 Jun 2033 |