FDA Orange Book
Is there a generic for Jylamvo?
Jylamvo contains methotrexate. 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 Jylamvo (methotrexate). The Orange Book shows its last listed patent expires October 28, 2035.
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Jylamvo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 2MG/ML | Marketed (Rx) | None | 0 | None |
NDA 212479, held by SHORLA PHARMA LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Jylamvo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11771701 | October 29, 2034 | Drug product | U-3700 | 212479 |
| 11771701 | October 29, 2034 | Drug product | U-3701 | 212479 |
| 11771701 | October 29, 2034 | Drug product | U-3702 | 212479 |
| 11771701 | October 29, 2034 | Drug product | U-3703 | 212479 |
| 11771701 | October 29, 2034 | Drug product | U-3704 | 212479 |
| 12605385 | October 25, 2035 | Drug product | None | 212479 |
| 11129833 | October 28, 2035 | Drug product | None | 212479 |
Jylamvo NDC codes
Questions
Is there a generic for Jylamvo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Jylamvo (methotrexate). The Orange Book shows its last listed patent expires October 28, 2035.
What is the generic name for Jylamvo?
The active ingredient in Jylamvo is methotrexate, per the FDA Orange Book.
When does the Jylamvo patent expire?
The last patent listed for Jylamvo in the Orange Book expires October 28, 2035. 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.