Orange Book product · Brand (NDA)
LAZCLUZE
LAZERTINIB MESYLATE
At a glance
Aug 19, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 19, 2024
1 yr 10 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Aug 19, 2029
in 3 yr 3 mo
Patent 9593098 expires
Listed drug substance patent expiration.
Oct 13, 2035
in 9 yr 5 mo
Patent 11453656 expires
Listed drug substance patent expiration.
Apr 18, 2038
in 12 yr
Patent 11981659 expires
Listed method-of-use patent (U-3985) expiration.
Apr 18, 2038
in 12 yr
Patent 12318390 expires
Listed drug product patent expiration.
Apr 18, 2038
in 12 yr
Patent 12599606 expires
Listed method-of-use patent (U-4512) expiration.
May 14, 2040
in 14 yr 1 mo
Patent 11879013 expires
Listed method-of-use patent (U-3985) expiration.
May 21, 2040
in 14 yr 2 mo
Patent 12138351 expires
Listed drug product patent expiration.
Apr 13, 2041
in 15 yr
Patent 11850248 expires
Listed method-of-use patent (U-3985) expiration.
Aug 01, 2041
in 15 yr 4 mo
Pharmaceutical detail
Active ingredient
LAZERTINIB MESYLATE
Strength
EQ 80MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219008
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Aug 19, 2029
in 3 yr 3 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9593098 | Oct 13, 2035 | in 9 yr 5 mo | SubstanceProductU-3985 |
| 11453656 | Apr 18, 2038 | in 12 yr | SubstanceProduct |
| 11981659 | Apr 18, 2038 | in 12 yr | U-3985 |
| 12318390 | Apr 18, 2038 | in 12 yr | Product |
| 12599606 | May 14, 2040 | in 14 yr 1 mo | U-4512 |
| 11879013 | May 21, 2040 | in 14 yr 2 mo | U-3985 |
| 12138351 | Apr 13, 2041 | in 15 yr | Product |
| 11850248 | Aug 01, 2041 | in 15 yr 4 mo | U-3985 |
