FDA Orange Book
Is there a generic for Lazcluze?
Lazcluze contains lazertinib. 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 Lazcluze (lazertinib). The Orange Book shows its last listed patent expires August 1, 2041 and its last listed exclusivity ends August 19, 2029.
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Lazcluze products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 240MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 80MG BASE | Marketed (Rx) | None | 0 | None |
NDA 219008, held by JANSSEN BIOTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lazcluze patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9593098 | October 13, 2035 | Drug substance, Drug product | U-3985 | 219008 |
| RE50528 | October 13, 2035 | Drug substance, Drug product | U-3985 | 219008 |
| 11981659 | April 18, 2038 | Method of use | U-3985 | 219008 |
| 11453656 | April 18, 2038 | Drug substance, Drug product | None | 219008 |
| 12318390 | April 18, 2038 | Drug product | None | 219008 |
| 12599606 | May 14, 2040 | Method of use | U-4512 | 219008 |
| 12599606 | May 14, 2040 | Method of use | U-4511 | 219008 |
| 11879013 | May 21, 2040 | Method of use | U-3985 | 219008 |
| 12138351 | April 13, 2041 | Drug product | None | 219008 |
| 11850248 | August 1, 2041 | Method of use | U-3985 | 219008 |
Lazcluze exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 19, 2029 | 219008 |
Lazcluze NDC codes
Questions
Is there a generic for Lazcluze?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lazcluze (lazertinib). The Orange Book shows its last listed patent expires August 1, 2041 and its last listed exclusivity ends August 19, 2029.
What is the generic name for Lazcluze?
The active ingredient in Lazcluze is lazertinib, per the FDA Orange Book.
When does the Lazcluze patent expire?
The last patent listed for Lazcluze in the Orange Book expires August 1, 2041. 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.