FDA Orange Book · active-ingredient family
Lazertinib mesylate
Lazertinib mesylate: 1 brand, 0 generics; first approved Aug 19, 2024; on patent until Oct 13, 2035.
On patent2 exclusivity periods
Generic status & protection
Protected until Oct 13, 2035 (earliest listed patent expiry).
Earliest patent expiry Oct 13, 2035Latest exclusivity ends Aug 19, 2029
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
8
Next patent expiry
Oct 13, 2035
in 9 yr 5 mo
Originator applications
Brand (NDA) products
LAZCLUZERLDJANSSEN BIOTECHNDA 21900820242 strengths
LAZCLUZERLD
JANSSEN BIOTECHNDA 21900820242 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 80MG BASE | TABLET | ORAL | Rx | — |
| EQ 240MG BASE | TABLET | ORAL | Rx | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Hatch-Waxman
Marketing exclusivity
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Aug 19, 2029
in 3 yr 2 mo
- NCENew chemical entity exclusivity (5 years)
Aug 19, 2029
in 3 yr 2 mo
Orange Book patent file
Listed patents
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9593098 | Oct 13, 2035 | in 9 yr 5 mo | SubstanceProductU-3985 |
| 11981659 | Apr 18, 2038 | in 11 yr 11 mo | U-3985 |
| 11453656 | Apr 18, 2038 | in 11 yr 11 mo | SubstanceProduct |
| 12318390 | Apr 18, 2038 | in 11 yr 11 mo | Product |
| 12599606 | May 14, 2040 | in 14 yr | U-4512 |
| 11879013 | May 21, 2040 | in 14 yr 1 mo | U-3985 |
| 12138351 | Apr 13, 2041 | in 15 yr | Product |
| 11850248 | Aug 01, 2041 | in 15 yr 3 mo | U-3985 |
FDA approval span
Approval history
First approval
Aug 19, 2024
1 yr 11 mo ago
Most recent approval
Aug 19, 2024
1 yr 11 mo ago
All 1 application were approved in 2024.
Brand (NDA) 1100%
Generic (ANDA) 00%
Lazertinib mesylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
