FDA Orange Book
Generic for Antara (micronized)
Antara (micronized) 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
Yes. The generic name for Antara (micronized) is fenofibrate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 5 Antara (micronized) products the Orange Book lists.
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Antara (micronized) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 130MG | Marketed (Rx) | AB | 2 | AB |
| capsule, oral | 30MG | Discontinued | None | 0 | None |
| capsule, oral | 43MG | Marketed (Rx) | AB | 2 | AB |
| capsule, oral | 87MG | Discontinued | None | 0 | None |
| capsule, oral | 90MG | Discontinued | None | 0 | None |
NDA 021695, held by LUPIN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fenofibrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 090859 | AB (A-rated, therapeutically equivalent) | March 1, 2012 | 130MG, 43MG |
| APOTEX INC | 202252 | AB (A-rated, therapeutically equivalent) | July 26, 2013 | 130MG, 43MG |
Antara (micronized) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9314447 | May 31, 2033 | Drug product | U-1447 | 021695 |
| 9314447 | May 31, 2033 | Drug product | U-1448 | 021695 |
Antara (micronized) NDC codes
Questions
Is there a generic for Antara (micronized)?
Yes. The generic name for Antara (micronized) is fenofibrate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 5 Antara (micronized) products the Orange Book lists.
What is the generic name for Antara (micronized)?
The active ingredient in Antara (micronized) is fenofibrate, per the FDA Orange Book.
When does the Antara (micronized) patent expire?
The last patent listed for Antara (micronized) in the Orange Book expires May 31, 2033. 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.