FDA Orange Book
Is there a generic for Alecensa?
Alecensa contains alectinib. 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 Alecensa (alectinib). The Orange Book shows its last listed patent expires April 24, 2035 and its last listed exclusivity ends April 18, 2031.
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Alecensa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 150MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208434, held by HOFFMANN-LA ROCHE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Alecensa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9440922 | June 9, 2030 | Drug product | None | 208434 |
| 9126931 | May 29, 2031 | Drug substance | None | 208434 |
| 9365514 | March 4, 2032 | Drug product | None | 208434 |
| 10350214 | April 24, 2035 | Drug product | None | 208434 |
| 11433076 | April 24, 2035 | Drug product | None | 208434 |
Alecensa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-947 | New indication | April 18, 2027 | 208434 |
| ODE-477 | Orphan drug exclusivity | April 18, 2031 | 208434 |
Alecensa NDC codes
Questions
Is there a generic for Alecensa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Alecensa (alectinib). The Orange Book shows its last listed patent expires April 24, 2035 and its last listed exclusivity ends April 18, 2031.
What is the generic name for Alecensa?
The active ingredient in Alecensa is alectinib, per the FDA Orange Book.
When does the Alecensa patent expire?
The last patent listed for Alecensa in the Orange Book expires April 24, 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.