FDA Orange Book
Generic for Lovaza
Lovaza contains omega-3-acid ethyl esters. 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 Lovaza is omega-3-acid ethyl esters. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lovaza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | Marketed (Rx) | AB | 9 | AB |
NDA 021654, held by WAYLIS THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic omega-3-acid ethyl esters
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PHARMOBEDIENT CONSULTING LLC | 091028 | AB (A-rated, therapeutically equivalent) | April 7, 2014 | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS |
| ONESOURCE SOFTGELS PTE LTD | 203893 | AB (A-rated, therapeutically equivalent) | September 19, 2017 | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS |
| ASCENT PHARMACEUTICALS INC | 207420 | AB (A-rated, therapeutically equivalent) | February 25, 2019 | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS |
| CHARTWELL LIFE MOLECULES LLC | 206455 | AB (A-rated, therapeutically equivalent) | August 7, 2019 | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS |
| CSPC-NBP PHARMACEUTICAL CO LTD | 211979 | AB (A-rated, therapeutically equivalent) | May 12, 2020 | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS |
| PURACAP PHARMACEUTICAL LLC | 210093 | AB (A-rated, therapeutically equivalent) | June 15, 2020 | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS |
| PHARMOBEDIENT CONSULTING LLC | 212504 | AB (A-rated, therapeutically equivalent) | August 19, 2020 | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS |
| MANKIND PHARMA LTD | 215458 | AB (A-rated, therapeutically equivalent) | November 15, 2021 | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS |
| WILSHIRE PHARMACEUTICALS INC | 211345 | AB (A-rated, therapeutically equivalent) | December 7, 2023 | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS |
Questions
Is there a generic for Lovaza?
Yes. The generic name for Lovaza is omega-3-acid ethyl esters. 8 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 Lovaza?
The active ingredient in Lovaza is omega-3-acid ethyl esters, per the FDA Orange Book.
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.