FDA Orange Book
Is there a generic for Lipofen?
Lipofen contains fenofibrate. 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 Lipofen (fenofibrate).
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Lipofen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Discontinued | None | 0 | None |
| capsule, oral | 150MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 021612, held by CIPHER PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lipofen NDC codes
Questions
Is there a generic for Lipofen?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lipofen (fenofibrate).
What is the generic name for Lipofen?
The active ingredient in Lipofen is fenofibrate, 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.
More on Lipofen and Fenofibrate
- What is Fenofibrate used for?FDA label uses
- Is Fenofibrate a controlled substance?Federal schedule
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- NDC 62559-305Lipofen NDC record
- NDC 62559-306Lipofen NDC record