FDA Orange Book
Is there a generic for Ojjaara?
Ojjaara contains momelotinib. 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 Ojjaara (momelotinib). The Orange Book shows its last listed patent expires December 2, 2040 and its last listed exclusivity ends September 15, 2030.
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Ojjaara products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 150MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
NDA 216873, held by GLAXOSMITHKLINE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ojjaara patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8486941 | January 3, 2035 | Drug substance, Drug product | U-1201 | 216873 |
| 9809559 | June 11, 2035 | Method of use | U-1201 | 216873 |
| RE48285 | June 11, 2035 | Drug substance, Drug product | U-1201 | 216873 |
| 12576089 | August 21, 2039 | Method of use | U-4441 | 216873 |
| 11963962 | December 2, 2040 | Method of use | U-3928 | 216873 |
Ojjaara exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 15, 2028 | 216873 |
| ODE-441 | Orphan drug exclusivity | September 15, 2030 | 216873 |
Ojjaara NDC codes
Questions
Is there a generic for Ojjaara?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ojjaara (momelotinib). The Orange Book shows its last listed patent expires December 2, 2040 and its last listed exclusivity ends September 15, 2030.
What is the generic name for Ojjaara?
The active ingredient in Ojjaara is momelotinib, per the FDA Orange Book.
When does the Ojjaara patent expire?
The last patent listed for Ojjaara in the Orange Book expires December 2, 2040. 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.