FDA Orange Book
Is there a generic for Omegaven?
Omegaven contains fish oil triglycerides. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Omegaven (fish oil triglycerides). The Orange Book shows its last listed patent expires July 30, 2026.
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Omegaven products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| emulsion, intravenous | 10GM/100ML (0.1GM/ML) | Marketed (Rx) | None | 0 | None |
| emulsion, intravenous | 5GM/50ML (0.1GM/ML) | Marketed (Rx) | None | 0 | None |
NDA 210589, held by FRESENIUS KABI USA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Omegaven patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9566260 | July 30, 2026 | Drug product | U-2366 | 210589 |
Omegaven NDC codes
Questions
Is there a generic for Omegaven?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Omegaven (fish oil triglycerides). The Orange Book shows its last listed patent expires July 30, 2026.
What is the generic name for Omegaven?
The active ingredient in Omegaven is fish oil triglycerides, per the FDA Orange Book.
When does the Omegaven patent expire?
The last patent listed for Omegaven in the Orange Book expires July 30, 2026. 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.