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FDA Orange Book · active-ingredient family

Omega-3-acid ethyl esters

Omega-3-acid ethyl esters is approved as 1 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LOVAZA · NDA 021654

1

Brand (NDA)

15

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
LOVAZARLDWAYLIS THERAPNDA 021654ABNov 10, 2004

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
OMEGA-3-ACID ETHYL ESTERSWILSHIRE PHARMS INCANDA 211345ABDec 07, 2023
OMEGA-3-ACID ETHYL ESTERSMANKIND PHARMAANDA 215458ABNov 15, 2021
OMEGA-3-ACID ETHYL ESTERSGLWANDA 212504ABAug 19, 2020
OMEGA-3-ACID ETHYL ESTERSPURACAP PHARM LLCANDA 210093ABJun 15, 2020
OMEGA-3-ACID ETHYL ESTERSCSPC-NBP PHARMANDA 211979ABMay 12, 2020
OMEGA-3-ACID ETHYL ESTERSSUN PHARMANDA 210834—Jan 09, 2020
OMEGA-3-ACID ETHYL ESTERSCHARTWELLANDA 206455ABAug 07, 2019
OMEGA-3-ACID ETHYL ESTERSSOFGEN PHARMSANDA 211355ABJul 10, 2019
OMEGA-3-ACID ETHYL ESTERSZYDUS LIFESCIENCESANDA 210107—Jun 14, 2019
OMEGA-3-ACID ETHYL ESTERSASCENT PHARMS INCANDA 207420ABFeb 25, 2019
OMEGA-3-ACID ETHYL ESTERSONESOURCE SPECIALTYANDA 203893ABSep 19, 2017
OMEGA-3-ACID ETHYL ESTERSAMNEAL PHARMSANDA 204940—Nov 27, 2015
OMEGA-3-ACID ETHYL ESTERSAPOTEXANDA 090973—Sep 30, 2014
OMEGA-3-ACID ETHYL ESTERSONESOURCE SPECIALTYANDA 091018—Jun 24, 2014
OMEGA-3-ACID ETHYL ESTERSGLWANDA 091028ABApr 07, 2014

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.

Omega-3-acid ethyl esters — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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