Orange Book product · Brand (NDA)
ALECENSA
ALECTINIB HYDROCHLORIDE
At a glance
Dec 11, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 11, 2015
10 yr 8 mo ago
Today
Exclusivity ends · I-947
New indication exclusivity (3 years)
Apr 18, 2027
in 10 mo
Patent 9440922 expires
Listed drug product patent expiration.
Jun 09, 2030
in 4 yr
Exclusivity ends · ODE-477
Orphan-drug exclusivity (7 years)
Apr 18, 2031
in 4 yr 11 mo
Patent 9126931 expires
Listed drug substance patent expiration.
May 29, 2031
in 5 yr
Patent 9365514 expires
Listed drug product patent expiration.
Mar 04, 2032
in 5 yr 10 mo
Patent 10350214 expires
Listed drug product patent expiration.
Apr 24, 2035
in 9 yr
Patent 11433076 expires
Listed drug product patent expiration.
Apr 24, 2035
in 9 yr
Pharmaceutical detail
Active ingredient
ALECTINIB HYDROCHLORIDE
Strength
EQ 150MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 208434
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 (2)
- I-947New indication exclusivity (3 years)
Apr 18, 2027
in 10 mo
- ODE-477Orphan-drug exclusivity (7 years)
Apr 18, 2031
in 4 yr 11 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9440922 | Jun 09, 2030 | in 4 yr | Product |
| 9126931 | May 29, 2031 | in 5 yr | Substance |
| 9365514 | Mar 04, 2032 | in 5 yr 10 mo | Product |
| 10350214 | Apr 24, 2035 | in 9 yr | Product |
| 11433076 | Apr 24, 2035 | in 9 yr | Product |
