Orange Book product · Brand (NDA)
ITOVEBI
INAVOLISIB
At a glance
Oct 10, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 10, 2024
1 yr 9 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Oct 10, 2029
in 3 yr 4 mo
Patent 8242104 expires
Listed drug substance patent expiration.
Sep 27, 2030
in 4 yr 4 mo
Patent 8343955 expires
Listed method-of-use patent (U-4024) expiration.
Sep 27, 2030
in 4 yr 4 mo
Patent 10851091 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11760753 expires
Listed method-of-use patent (U-4024) expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 9650393 expires
Listed drug substance patent expiration.
Jul 01, 2036
in 10 yr 2 mo
Patent 11028100 expires
Listed drug substance patent expiration.
Apr 26, 2038
in 12 yr
Patent 12410189 expires
Listed method-of-use patent (U-4024) expiration.
Jun 14, 2038
in 12 yr 2 mo
Pharmaceutical detail
Active ingredient
INAVOLISIB
Strength
3MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219249
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)
Oct 10, 2029
in 3 yr 4 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8242104 | Sep 27, 2030 | in 4 yr 4 mo | SubstanceProduct |
| 8343955 | Sep 27, 2030 | in 4 yr 4 mo | U-4024 |
| 10851091 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProduct |
| 11760753 | Jul 01, 2036 | in 10 yr 2 mo | U-4024 |
| 9650393 | Jul 01, 2036 | in 10 yr 2 mo | SubstanceProductU-4024 |
| 11028100 | Apr 26, 2038 | in 12 yr | SubstanceProduct |
| 12410189 | Jun 14, 2038 | in 12 yr 2 mo | U-4024 |
