FDA Orange Book
Is there a generic for Axtle?
Axtle contains pemetrexed. 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 Axtle (pemetrexed). The Orange Book shows its last listed patent expires June 25, 2045.
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Axtle products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 100MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| powder, intravenous | EQ 500MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 210661, held by AVYXA HOLDINGS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Axtle patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12721811 | June 25, 2045 | Drug product | None | 210661 |
Axtle NDC codes
Questions
Is there a generic for Axtle?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Axtle (pemetrexed). The Orange Book shows its last listed patent expires June 25, 2045.
What is the generic name for Axtle?
The active ingredient in Axtle is pemetrexed, per the FDA Orange Book.
When does the Axtle patent expire?
The last patent listed for Axtle in the Orange Book expires June 25, 2045. 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.