FDA Orange Book
Is there a generic for Lumakras?
Lumakras contains sotorasib. 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 Lumakras (sotorasib). The Orange Book shows its last listed patent expires September 15, 2040 and its last listed exclusivity ends January 16, 2032.
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Lumakras products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 120MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 240MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 320MG | Marketed (Rx) | None | 0 | None |
NDA 214665, held by AMGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lumakras patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10519146 | May 21, 2038 | Drug substance, Drug product | None | 214665 |
| 12280056 | November 18, 2039 | Method of use | U-4107 | 214665 |
| 12398133 | May 20, 2040 | Drug substance, Drug product | U-3306 | 214665 |
| 12398133 | May 20, 2040 | Drug substance, Drug product | U-4107 | 214665 |
| 11236091 | May 20, 2040 | Drug substance, Drug product | U-4107 | 214665 |
| 11827635 | May 20, 2040 | Drug substance, Drug product | U-4107 | 214665 |
| 11236091 | May 20, 2040 | Drug substance, Drug product | U-3306 | 214665 |
| 11827635 | May 20, 2040 | Drug substance, Drug product | U-3306 | 214665 |
| 11426404 | September 15, 2040 | Method of use | U-3306 | 214665 |
| 11426404 | September 15, 2040 | Method of use | U-4107 | 214665 |
Lumakras exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 28, 2026 | 214665 |
| I-962 | New indication | January 16, 2028 | 214665 |
| ODE-352 | Orphan drug exclusivity | May 28, 2028 | 214665 |
| ODE* | See the Orange Book exclusivity code list | May 28, 2028 | 214665 |
| ODE-507 | Orphan drug exclusivity | January 16, 2032 | 214665 |
Lumakras NDC codes
Questions
Is there a generic for Lumakras?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lumakras (sotorasib). The Orange Book shows its last listed patent expires September 15, 2040 and its last listed exclusivity ends January 16, 2032.
What is the generic name for Lumakras?
The active ingredient in Lumakras is sotorasib, per the FDA Orange Book.
When does the Lumakras patent expire?
The last patent listed for Lumakras in the Orange Book expires September 15, 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.