Orange Book product · Generic (ANDA)
ICOSAPENT ETHYL
ICOSAPENT ETHYL
At a glance
Aug 06, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 06, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
ICOSAPENT ETHYL
Strength
1GM
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 219156
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ICOSAPENT ETHYL
- 2012VASCEPABrand (NDA)
NDA 202057 · AMARIN PHARMS
- 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
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
