FDA Orange Book
Is there a generic for Lorbrena?
Lorbrena contains lorlatinib. 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 Lorbrena (lorlatinib). The Orange Book shows its last listed patent expires October 4, 2038 and its last listed exclusivity ends March 3, 2028.
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Lorbrena products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 25MG | Marketed (Rx) | None | 0 | None |
NDA 210868, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lorbrena patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8680111 | March 5, 2033 | Drug substance, Drug product | None | 210868 |
| 10420749 | July 27, 2036 | Drug substance, Drug product | U-2633 | 210868 |
| 10420749 | July 27, 2036 | Drug substance, Drug product | U-3096 | 210868 |
| 11020376 | July 27, 2036 | Drug product | None | 210868 |
| 11299500 | October 4, 2038 | Drug substance | None | 210868 |
Lorbrena exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-349 | Orphan drug exclusivity | March 3, 2028 | 210868 |
Lorbrena NDC codes
Questions
Is there a generic for Lorbrena?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lorbrena (lorlatinib). The Orange Book shows its last listed patent expires October 4, 2038 and its last listed exclusivity ends March 3, 2028.
What is the generic name for Lorbrena?
The active ingredient in Lorbrena is lorlatinib, per the FDA Orange Book.
When does the Lorbrena patent expire?
The last patent listed for Lorbrena in the Orange Book expires October 4, 2038. 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.