Orange Book product · Brand (NDA)
LORBRENA
LORLATINIB
At a glance
Nov 02, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 02, 2018
7 yr 9 mo ago
Today
Exclusivity ends · ODE-349
Orphan-drug exclusivity (7 years)
Mar 03, 2028
in 1 yr 9 mo
Patent 8680111 expires
Listed drug substance patent expiration.
Mar 05, 2033
in 6 yr 10 mo
Patent 10420749 expires
Listed drug substance patent expiration.
Jul 27, 2036
in 10 yr 3 mo
Patent 10420749 expires
Listed drug substance patent expiration.
Jul 27, 2036
in 10 yr 3 mo
Patent 11020376 expires
Listed drug product patent expiration.
Jul 27, 2036
in 10 yr 3 mo
Patent 11299500 expires
Listed drug substance patent expiration.
Oct 04, 2038
in 12 yr 6 mo
Pharmaceutical detail
Active ingredient
LORLATINIB
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 210868
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)
- ODE-349Orphan-drug exclusivity (7 years)
Mar 03, 2028
in 1 yr 9 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8680111 | Mar 05, 2033 | in 6 yr 10 mo | SubstanceProduct |
| 10420749 | Jul 27, 2036 | in 10 yr 3 mo | SubstanceProductU-2633 |
| 10420749 | Jul 27, 2036 | in 10 yr 3 mo | SubstanceProductU-3096 |
| 11020376 | Jul 27, 2036 | in 10 yr 3 mo | Product |
| 11299500 | Oct 04, 2038 | in 12 yr 6 mo | Substance |
