FDA application holder
Amarin Pharmaceuticals Ireland Ltd
The Orange Book identifies this organization as the applicant responsible for NDA 202057.
Orange Book drug · Brand (NDA)
Vascepa
Icosapent Ethyl
RLDNDA 202057 2 strengths Amarin Pharms
Approved
Jul 26, 2012
Strengths
2
Listed patents
61
What does the FDA Orange Book show for Vascepa?
Vascepa contains Icosapent Ethyl and is the new drug FDA Orange Book record for NDA 202057. The application has 2 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.
- FDA application
- NDA 202057
- Application holder
- Amarin Pharmaceuticals Ireland Ltd
- Product presentations
- 2
- Marketing categories
- Prescription
- Reference roles
- RLD / RS
- TE codes
- AB
- Listed patents
- 61
- Exclusivity records
- 0
New drug application identity from the Orange Book snapshot.
The listed applicant holds the FDA application; this field does not establish the product manufacturer.
Each FDA product number remains tied to its own strength, dosage form, route, and status.
Orange Book marketing categories do not establish real-time inventory or commercial availability.
RLD and RS designations are presentation-specific, not inferred from the trade name.
Therapeutic-equivalence codes apply only within the matching Orange Book product heading.
A zero means none appear in this snapshot, not that no patent rights exist.
FDA exclusivity and listed patent protection are distinct regulatory concepts.
Sourced from the official FDA Orange Book data file · snapshot refreshed
FDA product-presentation matrix
Every product number in this exact application
| Product | Strength | Dosage form / route | Marketing status | TE code | Reference role |
|---|---|---|---|---|---|
| 001 | 1GM | CAPSULEORAL | Prescription | AB | RLDRS |
| 002 | 500MG | CAPSULEORAL | Prescription | AB | RLD |
Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.
Who is responsible for this application?
Application holder is not the same as manufacturer
Manufacturer status
Not established by the Orange Book
A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.
Regulatory interpretation
What the record means, and what it does not
FDA marketing status
2 presentations listed as prescription
RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.
Therapeutic equivalence
TE code AB across rated presentations
An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.
Patent & exclusivity record
61 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026
The latest future date recorded across those files is Jun 28, 2033. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.
Same-ingredient landscape
11 other ANDAs and 0 other NDAs found
11 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.
Which products are meaningfully comparable?
Exact ingredient + dosage form + route cohorts
NDA 202057 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.
Capsule · Oral
Icosapent Ethyl
- Product rows
- 20
- Active applications
- 12
- Active with AB row
- 12
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue NDA-202057
No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.
Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.
Strengths & dosage forms
2 approved presentations · NDA 202057
TE ABRLDRS
- Strength
- 1GM
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
14 yr 2 mo ago
Today
Patent 9700537 expires
Listed method-of-use patent (U-2707) expiration.
in 10 mo
Patent 9198892 expires
Listed method-of-use patent (U-2706) expiration.
in 1 yr 2 mo
Patent 12171738 expires
Listed method-of-use patent (U-4105) expiration.
in 3 yr 7 mo
Patent 8415335 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 7 mo
Patent 8426399 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 7 mo
Patent 8518929 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 7 mo
Patent 8524698 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 7 mo
Patent 8546372 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 7 mo
Patent 8680144 expires
Listed method-of-use patent (U-2695) expiration.
in 3 yr 7 mo
Patent 10010517 expires
Listed method-of-use patent (U-2690) expiration.
in 3 yr 10 mo
Patent 10265287 expires
Listed method-of-use patent (U-2700) expiration.
in 3 yr 10 mo
Patent 10792267 expires
Listed method-of-use patent (U-2961) expiration.
in 3 yr 10 mo
Patent 10842766 expires
Listed method-of-use patent (U-2997) expiration.
in 3 yr 10 mo
Patent 10881632 expires
Listed method-of-use patent (U-3052) expiration.
in 3 yr 10 mo
Patent 11103477 expires
Listed method-of-use patent (U-3209) expiration.
in 3 yr 10 mo
Patent 11154526 expires
Listed method-of-use patent (U-3240) expiration.
in 3 yr 10 mo
Patent 11213504 expires
Listed method-of-use patent (U-3292) expiration.
in 3 yr 10 mo
Patent 11717504 expires
Listed method-of-use patent (U-3669) expiration.
in 3 yr 10 mo
Patent 8298554 expires
Listed drug product patent expiration.
in 3 yr 10 mo
Patent 8445003 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 10 mo
Patent 8445013 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 10 mo
Patent 8454994 expires
Listed method-of-use patent (U-2689) expiration.
in 3 yr 10 mo
Patent 8501225 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 10 mo
Patent 8563608 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 10 mo
Patent 8617593 expires
Listed method-of-use patent (U-1478) expiration.
in 3 yr 10 mo
Patent 8617593 expires
Listed method-of-use patent (U-2691) expiration.
in 3 yr 10 mo
Patent 8617594 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 10 mo
Patent 8618166 expires
Listed method-of-use patent (U-2689) expiration.
in 3 yr 10 mo
Patent 8623406 expires
Listed method-of-use patent (U-2692) expiration.
in 3 yr 10 mo
Patent 8623406 expires
Listed method-of-use patent (U-1478) expiration.
in 3 yr 10 mo
Patent 8642077 expires
Listed method-of-use patent (U-2693) expiration.
in 3 yr 10 mo
Patent 8691871 expires
Listed method-of-use patent (U-2689) expiration.
in 3 yr 10 mo
Patent 8703185 expires
Listed method-of-use patent (U-2691) expiration.
in 3 yr 10 mo
Patent 8709475 expires
Listed method-of-use patent (U-2689) expiration.
in 3 yr 10 mo
Patent 10842768 expires
Listed method-of-use patent (U-2688) expiration.
in 3 yr 11 mo
Patent 8410086 expires
Listed method-of-use patent (U-2688) expiration.
in 3 yr 11 mo
Patent 8455472 expires
Listed method-of-use patent (U-2690) expiration.
in 3 yr 11 mo
Patent 8669245 expires
Listed method-of-use patent (U-2694) expiration.
in 3 yr 11 mo
Patent 8710041 expires
Listed method-of-use patent (U-2690) expiration.
in 3 yr 11 mo
Patent 10278935 expires
Listed method-of-use patent (U-2701) expiration.
in 7 yr
Patent 10278936 expires
Listed method-of-use patent (U-2702) expiration.
in 7 yr
Patent 10278937 expires
Listed method-of-use patent (U-2703) expiration.
in 7 yr
Patent 10383840 expires
Listed method-of-use patent (U-2704) expiration.
in 7 yr
Patent 10555924 expires
Listed method-of-use patent (U-2743) expiration.
in 7 yr
Patent 10555925 expires
Listed method-of-use patent (U-2744) expiration.
in 7 yr
Patent 10568861 expires
Listed method-of-use patent (U-2756) expiration.
in 7 yr
Patent 10576054 expires
Listed method-of-use patent (U-2762) expiration.
in 7 yr
Patent 10668042 expires
Listed method-of-use patent (U-2841) expiration.
in 7 yr
Patent 10786478 expires
Listed method-of-use patent (U-2959) expiration.
in 7 yr
Patent 10786478 expires
Listed method-of-use patent (U-2960) expiration.
in 7 yr
Patent 10792270 expires
Listed method-of-use patent (U-2962) expiration.
in 7 yr
Patent 10894028 expires
Listed method-of-use patent (U-3053) expiration.
in 7 yr
Patent 11000499 expires
Listed method-of-use patent (U-3126) expiration.
in 7 yr
Patent 11116742 expires
Listed method-of-use patent (U-3221) expiration.
in 7 yr
Patent 11298333 expires
Listed method-of-use patent (U-3358) expiration.
in 7 yr
Patent 11369582 expires
Listed method-of-use patent (U-2841) expiration.
in 7 yr
Patent 9603826 expires
Listed method-of-use patent (U-2696) expiration.
in 7 yr
Patent 9610272 expires
Listed method-of-use patent (U-2697) expiration.
in 7 yr
Patent 9623001 expires
Listed method-of-use patent (U-2698) expiration.
in 7 yr
Patent 9693984 expires
Listed method-of-use patent (U-2697) expiration.
in 7 yr
Patent 9693985 expires
Listed method-of-use patent (U-2696) expiration.
in 7 yr
Patent 9693986 expires
Listed method-of-use patent (U-2698) expiration.
in 7 yr
Patent 9918954 expires
Listed method-of-use patent (U-2699) expiration.
in 7 yr
Patent & exclusivity timeline
Protection horizonPatent expiryExclusivity endToday
Pharmaceutical detail
FDA product recordActive ingredient
ICOSAPENT ETHYL
Strength
1GM
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 202057
Product number
001
Marketing status
Prescription
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Listed patents
Orange Book patent file| Patent | Expires | In | Type |
|---|---|---|---|
| 9700537 | in 10 mo | U-2707 | |
| 9198892 | in 1 yr 2 mo | U-2706 | |
| 12171738 | in 3 yr 7 mo | U-4105 | |
| 8415335 | in 3 yr 7 mo | U-1287 | |
| 8426399 | in 3 yr 7 mo | U-1287 | |
| 8518929 | in 3 yr 7 mo | U-1287 | |
| 8524698 | in 3 yr 7 mo | U-1287 | |
| 8546372 | in 3 yr 7 mo | U-1287 | |
| 8680144 | in 3 yr 7 mo | U-2695 | |
| 10010517 | in 3 yr 10 mo | U-2690 | |
| 10265287 | in 3 yr 10 mo | U-2700 | |
| 10792267 | in 3 yr 10 mo | U-2961 | |
| 10842766 | in 3 yr 10 mo | U-2997 | |
| 10881632 | in 3 yr 10 mo | U-3052 | |
| 11103477 | in 3 yr 10 mo | U-3209 | |
| 11154526 | in 3 yr 10 mo | U-3240 | |
| 11213504 | in 3 yr 10 mo | U-3292 | |
| 11717504 | in 3 yr 10 mo | U-3669 | |
| 8298554 | in 3 yr 10 mo | Product | |
| 8445003 | in 3 yr 10 mo | U-1287 | |
| 8445013 | in 3 yr 10 mo | U-1287 | |
| 8454994 | in 3 yr 10 mo | U-2689 | |
| 8501225 | in 3 yr 10 mo | U-1287 | |
| 8563608 | in 3 yr 10 mo | U-1287 | |
| 8617593 | in 3 yr 10 mo | U-1478 | |
| 8617593 | in 3 yr 10 mo | U-2691 | |
| 8617594 | in 3 yr 10 mo | U-1287 | |
| 8618166 | in 3 yr 10 mo | U-2689 | |
| 8623406 | in 3 yr 10 mo | U-2692 | |
| 8623406 | in 3 yr 10 mo | U-1478 | |
| 8642077 | in 3 yr 10 mo | U-2693 | |
| 8691871 | in 3 yr 10 mo | U-2689 | |
| 8703185 | in 3 yr 10 mo | U-2691 | |
| 8709475 | in 3 yr 10 mo | U-2689 | |
| 10842768 | in 3 yr 11 mo | U-2688 | |
| 8410086 | in 3 yr 11 mo | U-2688 | |
| 8455472 | in 3 yr 11 mo | U-2690 | |
| 8669245 | in 3 yr 11 mo | U-2694 | |
| 8710041 | in 3 yr 11 mo | U-2690 | |
| 10278935 | in 7 yr | U-2701 | |
| 10278936 | in 7 yr | U-2702 | |
| 10278937 | in 7 yr | U-2703 | |
| 10383840 | in 7 yr | U-2704 | |
| 10555924 | in 7 yr | U-2743 | |
| 10555925 | in 7 yr | U-2744 | |
| 10568861 | in 7 yr | U-2756 | |
| 10576054 | in 7 yr | U-2762 | |
| 10668042 | in 7 yr | U-2841 | |
| 10786478 | in 7 yr | U-2959 | |
| 10786478 | in 7 yr | U-2960 | |
| 10792270 | in 7 yr | U-2962 | |
| 10894028 | in 7 yr | U-3053 | |
| 11000499 | in 7 yr | U-3126 | |
| 11116742 | in 7 yr | U-3221 | |
| 11298333 | in 7 yr | U-3358 | |
| 11369582 | in 7 yr | U-2841 | |
| 9603826 | in 7 yr | U-2696 | |
| 9610272 | in 7 yr | U-2697 | |
| 9623001 | in 7 yr | U-2698 | |
| 9693984 | in 7 yr | U-2697 | |
| 9693985 | in 7 yr | U-2696 | |
| 9693986 | in 7 yr | U-2698 | |
| 9918954 | in 7 yr | U-2699 |
TE ABRLD
- Strength
- 500MG
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
9 yr 7 mo ago
Today
Patent 9700537 expires
Listed method-of-use patent (U-2707) expiration.
in 10 mo
Patent 9198892 expires
Listed method-of-use patent (U-2706) expiration.
in 1 yr 2 mo
Patent 12171738 expires
Listed method-of-use patent (U-4105) expiration.
in 3 yr 7 mo
Patent 8399446 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 7 mo
Patent 8415335 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 7 mo
Patent 8426399 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 7 mo
Patent 8518929 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 7 mo
Patent 8524698 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 7 mo
Patent 8546372 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 7 mo
Patent 8680144 expires
Listed method-of-use patent (U-2695) expiration.
in 3 yr 7 mo
Patent 10010517 expires
Listed method-of-use patent (U-2690) expiration.
in 3 yr 10 mo
Patent 10265287 expires
Listed method-of-use patent (U-2700) expiration.
in 3 yr 10 mo
Patent 10792267 expires
Listed method-of-use patent (U-2961) expiration.
in 3 yr 10 mo
Patent 10842766 expires
Listed method-of-use patent (U-2997) expiration.
in 3 yr 10 mo
Patent 10881632 expires
Listed method-of-use patent (U-3052) expiration.
in 3 yr 10 mo
Patent 11103477 expires
Listed method-of-use patent (U-3209) expiration.
in 3 yr 10 mo
Patent 11154526 expires
Listed method-of-use patent (U-3240) expiration.
in 3 yr 10 mo
Patent 11213504 expires
Listed method-of-use patent (U-3292) expiration.
in 3 yr 10 mo
Patent 11717504 expires
Listed method-of-use patent (U-3669) expiration.
in 3 yr 10 mo
Patent 8298554 expires
Listed drug product patent expiration.
in 3 yr 10 mo
Patent 8445003 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 10 mo
Patent 8445013 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 10 mo
Patent 8454994 expires
Listed method-of-use patent (U-2689) expiration.
in 3 yr 10 mo
Patent 8501225 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 10 mo
Patent 8563608 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 10 mo
Patent 8617593 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 10 mo
Patent 8617593 expires
Listed method-of-use patent (U-2691) expiration.
in 3 yr 10 mo
Patent 8617594 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 10 mo
Patent 8623406 expires
Listed method-of-use patent (U-1287) expiration.
in 3 yr 10 mo
Patent 8623406 expires
Listed method-of-use patent (U-2692) expiration.
in 3 yr 10 mo
Patent 8642077 expires
Listed method-of-use patent (U-2693) expiration.
in 3 yr 10 mo
Patent 8691871 expires
Listed method-of-use patent (U-2689) expiration.
in 3 yr 10 mo
Patent 8703185 expires
Listed method-of-use patent (U-2691) expiration.
in 3 yr 10 mo
Patent 8709475 expires
Listed method-of-use patent (U-2689) expiration.
in 3 yr 10 mo
Patent 10842768 expires
Listed method-of-use patent (U-2688) expiration.
in 3 yr 11 mo
Patent 8410086 expires
Listed method-of-use patent (U-2688) expiration.
in 3 yr 11 mo
Patent 8669245 expires
Listed method-of-use patent (U-2694) expiration.
in 3 yr 11 mo
Patent 8710041 expires
Listed method-of-use patent (U-2690) expiration.
in 3 yr 11 mo
Patent 10278935 expires
Listed method-of-use patent (U-2701) expiration.
in 7 yr
Patent 10278936 expires
Listed method-of-use patent (U-2702) expiration.
in 7 yr
Patent 10278937 expires
Listed method-of-use patent (U-2703) expiration.
in 7 yr
Patent 10383840 expires
Listed method-of-use patent (U-2704) expiration.
in 7 yr
Patent 10555924 expires
Listed method-of-use patent (U-2743) expiration.
in 7 yr
Patent 10555925 expires
Listed method-of-use patent (U-2744) expiration.
in 7 yr
Patent 10568861 expires
Listed method-of-use patent (U-2756) expiration.
in 7 yr
Patent 10576054 expires
Listed method-of-use patent (U-2762) expiration.
in 7 yr
Patent 10668042 expires
Listed method-of-use patent (U-2841) expiration.
in 7 yr
Patent 10786478 expires
Listed method-of-use patent (U-2959) expiration.
in 7 yr
Patent 10786478 expires
Listed method-of-use patent (U-2960) expiration.
in 7 yr
Patent 10792270 expires
Listed method-of-use patent (U-2962) expiration.
in 7 yr
Patent 10894028 expires
Listed method-of-use patent (U-3053) expiration.
in 7 yr
Patent 11000499 expires
Listed method-of-use patent (U-3126) expiration.
in 7 yr
Patent 11116742 expires
Listed method-of-use patent (U-3221) expiration.
in 7 yr
Patent 11298333 expires
Listed method-of-use patent (U-3358) expiration.
in 7 yr
Patent 11369582 expires
Listed method-of-use patent (U-2841) expiration.
in 7 yr
Patent 9603826 expires
Listed method-of-use patent (U-2696) expiration.
in 7 yr
Patent 9610272 expires
Listed method-of-use patent (U-2697) expiration.
in 7 yr
Patent 9623001 expires
Listed method-of-use patent (U-2698) expiration.
in 7 yr
Patent 9693984 expires
Listed method-of-use patent (U-2697) expiration.
in 7 yr
Patent 9693985 expires
Listed method-of-use patent (U-2696) expiration.
in 7 yr
Patent 9693986 expires
Listed method-of-use patent (U-2698) expiration.
in 7 yr
Patent 9918954 expires
Listed method-of-use patent (U-2699) expiration.
in 7 yr
Patent & exclusivity timeline
Protection horizonPatent expiryExclusivity endToday
Pharmaceutical detail
FDA product recordActive ingredient
ICOSAPENT ETHYL
Strength
500MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 202057
Product number
002
Marketing status
Prescription
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Listed patents
Orange Book patent file| Patent | Expires | In | Type |
|---|---|---|---|
| 9700537 | in 10 mo | U-2707 | |
| 9198892 | in 1 yr 2 mo | U-2706 | |
| 12171738 | in 3 yr 7 mo | U-4105 | |
| 8399446 | in 3 yr 7 mo | U-1287 | |
| 8415335 | in 3 yr 7 mo | U-1287 | |
| 8426399 | in 3 yr 7 mo | U-1287 | |
| 8518929 | in 3 yr 7 mo | U-1287 | |
| 8524698 | in 3 yr 7 mo | U-1287 | |
| 8546372 | in 3 yr 7 mo | U-1287 | |
| 8680144 | in 3 yr 7 mo | U-2695 | |
| 10010517 | in 3 yr 10 mo | U-2690 | |
| 10265287 | in 3 yr 10 mo | U-2700 | |
| 10792267 | in 3 yr 10 mo | U-2961 | |
| 10842766 | in 3 yr 10 mo | U-2997 | |
| 10881632 | in 3 yr 10 mo | U-3052 | |
| 11103477 | in 3 yr 10 mo | U-3209 | |
| 11154526 | in 3 yr 10 mo | U-3240 | |
| 11213504 | in 3 yr 10 mo | U-3292 | |
| 11717504 | in 3 yr 10 mo | U-3669 | |
| 8298554 | in 3 yr 10 mo | Product | |
| 8445003 | in 3 yr 10 mo | U-1287 | |
| 8445013 | in 3 yr 10 mo | U-1287 | |
| 8454994 | in 3 yr 10 mo | U-2689 | |
| 8501225 | in 3 yr 10 mo | U-1287 | |
| 8563608 | in 3 yr 10 mo | U-1287 | |
| 8617593 | in 3 yr 10 mo | U-1287 | |
| 8617593 | in 3 yr 10 mo | U-2691 | |
| 8617594 | in 3 yr 10 mo | U-1287 | |
| 8623406 | in 3 yr 10 mo | U-1287 | |
| 8623406 | in 3 yr 10 mo | U-2692 | |
| 8642077 | in 3 yr 10 mo | U-2693 | |
| 8691871 | in 3 yr 10 mo | U-2689 | |
| 8703185 | in 3 yr 10 mo | U-2691 | |
| 8709475 | in 3 yr 10 mo | U-2689 | |
| 10842768 | in 3 yr 11 mo | U-2688 | |
| 8410086 | in 3 yr 11 mo | U-2688 | |
| 8669245 | in 3 yr 11 mo | U-2694 | |
| 8710041 | in 3 yr 11 mo | U-2690 | |
| 10278935 | in 7 yr | U-2701 | |
| 10278936 | in 7 yr | U-2702 | |
| 10278937 | in 7 yr | U-2703 | |
| 10383840 | in 7 yr | U-2704 | |
| 10555924 | in 7 yr | U-2743 | |
| 10555925 | in 7 yr | U-2744 | |
| 10568861 | in 7 yr | U-2756 | |
| 10576054 | in 7 yr | U-2762 | |
| 10668042 | in 7 yr | U-2841 | |
| 10786478 | in 7 yr | U-2959 | |
| 10786478 | in 7 yr | U-2960 | |
| 10792270 | in 7 yr | U-2962 | |
| 10894028 | in 7 yr | U-3053 | |
| 11000499 | in 7 yr | U-3126 | |
| 11116742 | in 7 yr | U-3221 | |
| 11298333 | in 7 yr | U-3358 | |
| 11369582 | in 7 yr | U-2841 | |
| 9603826 | in 7 yr | U-2696 | |
| 9610272 | in 7 yr | U-2697 | |
| 9623001 | in 7 yr | U-2698 | |
| 9693984 | in 7 yr | U-2697 | |
| 9693985 | in 7 yr | U-2696 | |
| 9693986 | in 7 yr | U-2698 | |
| 9918954 | in 7 yr | U-2699 |
Active-ingredient family
Brand + generics
This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025Icosapent EthylGeneric (ANDA)
ANDA 219156 · Xiamen LP Pharm Co
- 2024Icosapent EthylGeneric (ANDA)
ANDA 218994 · Torrent
- 2024Icosapent EthylGeneric (ANDA)
ANDA 218899 · Qilu
- 2024Icosapent EthylGeneric (ANDA)
ANDA 216811 · Ascent Pharms Inc
- 2023Icosapent EthylGeneric (ANDA)
ANDA 217919 · Humanwell Puracap
- 2023Icosapent EthylGeneric (ANDA)
ANDA 217844 · Onesource Specialty
- 2023Icosapent EthylGeneric (ANDA)
ANDA 217656 · Zydus Lifesciences
- 2021Icosapent EthylGeneric (ANDA)
ANDA 209437 · Apotex
- 2020Icosapent EthylGeneric (ANDA)
ANDA 209525 · Teva Pharms USA
- 2020Icosapent EthylGeneric (ANDA)
ANDA 209499 · DR Reddys
- 2020Icosapent EthylGeneric (ANDA)
ANDA 209457 · Hikma
How to use this record responsibly
Scope, limitations, and primary sources
What to verify before making a decision
- The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
- RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
- Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
- Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
- The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.
Official FDA references
- Electronic Orange Book record
- Orange Book preface and TE-code policy
- FDA product, patent, and exclusivity data files
Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.
Vascepa: frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.
Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 202057 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
