FDA Orange Book
Generic for Vascepa
Vascepa contains icosapent ethyl. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Vascepa is icosapent ethyl. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Vascepa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 1GM | Marketed (Rx) | AB | 12 | AB |
| capsule, oral | 500MG | Marketed (Rx) | AB | 7 | AB |
NDA 202057, held by AMARIN PHARMACEUTICALS IRELAND LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic icosapent ethyl
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 209457 | AB (A-rated, therapeutically equivalent) | May 21, 2020 | 1GM, 500MG |
| DR REDDYS LABORATORIES INC | 209499 | AB (A-rated, therapeutically equivalent) | August 7, 2020 | 1GM, 500MG |
| TEVA PHARMACEUTICALS USA | 209525 | AB (A-rated, therapeutically equivalent) | September 11, 2020 | 1GM, 500MG |
| APOTEX INC | 209437 | AB (A-rated, therapeutically equivalent) | June 30, 2021 | 1GM |
| ZYDUS LIFESCIENCES GLOBAL FZE | 217656 | AB (A-rated, therapeutically equivalent) | April 20, 2023 | 1GM, 500MG |
| ONESOURCE SOFTGELS PTE LTD | 217844 | AB (A-rated, therapeutically equivalent) | September 22, 2023 | 1GM, 500MG |
| HUMANWELL PURACAP PHARMACEUTICAL WUHAN CO LTD | 217919 | AB (A-rated, therapeutically equivalent) | December 22, 2023 | 1GM, 500MG |
| ASCENT PHARMACEUTICALS INC | 216811 | AB (A-rated, therapeutically equivalent) | February 16, 2024 | 1GM, 500MG |
| QILU PHARMACEUTICAL CO LTD | 218899 | AB (A-rated, therapeutically equivalent) | November 20, 2024 | 1GM |
| TORRENT PHARMA INC | 218994 | AB (A-rated, therapeutically equivalent) | December 20, 2024 | 1GM |
| XIAMEN LP PHARMACUETICAL CO LTD | 219156 | AB (A-rated, therapeutically equivalent) | August 6, 2025 | 1GM |
| AUROBINDO PHARMA LTD | 218949 | AB (A-rated, therapeutically equivalent) | June 24, 2026 | 1GM |
Vascepa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9700537 | May 31, 2027 | Method of use | U-2707 | 202057 |
| 9198892 | September 25, 2027 | Method of use | U-2706 | 202057 |
| 8524698 | February 9, 2030 | Method of use | U-1287 | 202057 |
| 8546372 | February 9, 2030 | Method of use | U-1287 | 202057 |
| 8680144 | February 9, 2030 | Method of use | U-2695 | 202057 |
| 8426399 | February 9, 2030 | Method of use | U-1287 | 202057 |
| 12171738 | February 9, 2030 | Method of use | U-4105 | 202057 |
| 8415335 | February 9, 2030 | Method of use | U-1287 | 202057 |
| 8518929 | February 9, 2030 | Method of use | U-1287 | 202057 |
| 8399446 | February 9, 2030 | Method of use | U-1287 | 202057 |
| 8501225 | April 29, 2030 | Method of use | U-1287 | 202057 |
| 8617593 | April 29, 2030 | Method of use | U-1478 | 202057 |
| 8617594 | April 29, 2030 | Method of use | U-1287 | 202057 |
| 8445003 | April 29, 2030 | Method of use | U-1287 | 202057 |
| 8454994 | April 29, 2030 | Method of use | U-2689 | 202057 |
| 8617593 | April 29, 2030 | Method of use | U-2691 | 202057 |
| 8618166 | April 29, 2030 | Method of use | U-2689 | 202057 |
| 8623406 | April 29, 2030 | Method of use | U-2692 | 202057 |
| 8642077 | April 29, 2030 | Method of use | U-2693 | 202057 |
| 8703185 | April 29, 2030 | Method of use | U-2691 | 202057 |
| 8691871 | April 29, 2030 | Method of use | U-2689 | 202057 |
| 8709475 | April 29, 2030 | Method of use | U-2689 | 202057 |
| 10010517 | April 29, 2030 | Method of use | U-2690 | 202057 |
| 10265287 | April 29, 2030 | Method of use | U-2700 | 202057 |
| 8563608 | April 29, 2030 | Method of use | U-1287 | 202057 |
| 11154526 | April 29, 2030 | Method of use | U-3240 | 202057 |
| 11717504 | April 29, 2030 | Method of use | U-3669 | 202057 |
| 10792267 | April 29, 2030 | Method of use | U-2961 | 202057 |
| 10842766 | April 29, 2030 | Method of use | U-2997 | 202057 |
| 10881632 | April 29, 2030 | Method of use | U-3052 | 202057 |
| 11103477 | April 29, 2030 | Method of use | U-3209 | 202057 |
| 8623406 | April 29, 2030 | Method of use | U-1478 | 202057 |
| 8445013 | April 29, 2030 | Method of use | U-1287 | 202057 |
| 11213504 | April 29, 2030 | Method of use | U-3292 | 202057 |
| 8298554 | April 29, 2030 | Drug product | None | 202057 |
| 8623406 | April 29, 2030 | Method of use | U-1287 | 202057 |
| 8617593 | April 29, 2030 | Method of use | U-1287 | 202057 |
| 8410086 | June 15, 2030 | Method of use | U-2688 | 202057 |
| 8455472 | June 15, 2030 | Method of use | U-2690 | 202057 |
| 8669245 | June 15, 2030 | Method of use | U-2694 | 202057 |
| 8710041 | June 15, 2030 | Method of use | U-2690 | 202057 |
| 10842768 | June 15, 2030 | Method of use | U-2688 | 202057 |
| 9603826 | June 28, 2033 | Method of use | U-2696 | 202057 |
| 9610272 | June 28, 2033 | Method of use | U-2697 | 202057 |
| 9623001 | June 28, 2033 | Method of use | U-2698 | 202057 |
| 9693984 | June 28, 2033 | Method of use | U-2697 | 202057 |
| 9693985 | June 28, 2033 | Method of use | U-2696 | 202057 |
| 9693986 | June 28, 2033 | Method of use | U-2698 | 202057 |
| 9918954 | June 28, 2033 | Method of use | U-2699 | 202057 |
| 10278935 | June 28, 2033 | Method of use | U-2701 | 202057 |
| 10278937 | June 28, 2033 | Method of use | U-2703 | 202057 |
| 10278936 | June 28, 2033 | Method of use | U-2702 | 202057 |
| 10383840 | June 28, 2033 | Method of use | U-2704 | 202057 |
| 10555925 | June 28, 2033 | Method of use | U-2744 | 202057 |
| 10555924 | June 28, 2033 | Method of use | U-2743 | 202057 |
| 11369582 | June 28, 2033 | Method of use | U-2841 | 202057 |
| 11298333 | June 28, 2033 | Method of use | U-3358 | 202057 |
| 10568861 | June 28, 2033 | Method of use | U-2756 | 202057 |
| 10668042 | June 28, 2033 | Method of use | U-2841 | 202057 |
| 10576054 | June 28, 2033 | Method of use | U-2762 | 202057 |
Showing 60 of 66 listed patents.
Vascepa NDC codes
Questions
Is there a generic for Vascepa?
Yes. The generic name for Vascepa is icosapent ethyl. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Vascepa?
The active ingredient in Vascepa is icosapent ethyl, per the FDA Orange Book.
When does the Vascepa patent expire?
The last patent listed for Vascepa in the Orange Book expires June 28, 2033. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Vascepa and Icosapent Ethyl
- What is Vascepa used for?FDA label uses
- Is Vascepa a controlled substance?Federal schedule
- What is Icosapent Ethyl used for?FDA label uses
- Is Icosapent Ethyl a controlled substance?Federal schedule
- Vascepa Medicare Part D coverageBy plan and state
- NDC 52937-001Vascepa NDC record
- NDC 52937-003Vascepa NDC record
- NDC 52937-005Vascepa NDC record