FDA Orange Book
Is there a generic for Ninlaro?
Ninlaro contains ixazomib. 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 Ninlaro (ixazomib). The Orange Book shows its last listed patent expires November 20, 2029.
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Ninlaro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 2.3MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 3MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 4MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208462, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ninlaro patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8871745 | August 6, 2027 | Method of use | U-2434 | 208462 |
| 8003819 | August 6, 2027 | Drug substance, Drug product | U-2434 | 208462 |
| 8530694 | August 6, 2027 | Drug substance, Drug product | U-2434 | 208462 |
| 7687662 | August 6, 2027 | Drug substance, Drug product | None | 208462 |
| 9175017 | June 16, 2029 | Method of use | U-2434 | 208462 |
| 8859504 | June 16, 2029 | Drug substance, Drug product | None | 208462 |
| 7442830 | November 20, 2029 | Drug substance, Drug product | U-2434 | 208462 |
Ninlaro NDC codes
Questions
Is there a generic for Ninlaro?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ninlaro (ixazomib). The Orange Book shows its last listed patent expires November 20, 2029.
What is the generic name for Ninlaro?
The active ingredient in Ninlaro is ixazomib, per the FDA Orange Book.
When does the Ninlaro patent expire?
The last patent listed for Ninlaro in the Orange Book expires November 20, 2029. 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.