FDA Orange Book
Is there a generic for Pemfexy?
Pemfexy 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 Pemfexy (pemetrexed). The Orange Book shows its last listed patent expires February 19, 2036.
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Pemfexy products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 500MG/20ML (25MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 209472, held by EAGLE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Pemfexy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9604990 | October 28, 2035 | Drug substance | None | 209472 |
| 12115164 | February 19, 2036 | Method of use | U-4246 | 209472 |
| 12115164 | February 19, 2036 | Method of use | U-4247 | 209472 |
| 12115164 | February 19, 2036 | Method of use | U-4248 | 209472 |
| 11793813 | February 19, 2036 | Drug product | None | 209472 |
Pemfexy NDC codes
Questions
Is there a generic for Pemfexy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pemfexy (pemetrexed). The Orange Book shows its last listed patent expires February 19, 2036.
What is the generic name for Pemfexy?
The active ingredient in Pemfexy is pemetrexed, per the FDA Orange Book.
When does the Pemfexy patent expire?
The last patent listed for Pemfexy in the Orange Book expires February 19, 2036. 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.