Orange Book product · Brand (NDA)
TABRECTA
CAPMATINIB HYDROCHLORIDE
At a glance
May 06, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 06, 2020
6 yr 3 mo ago
Today
Exclusivity ends · ODE-291
Orphan-drug exclusivity (7 years)
May 06, 2027
in 11 mo
Patent 12084449 expires
Listed method-of-use patent (U-2813) expiration.
Nov 19, 2027
in 1 yr 5 mo
Patent 8461330 expires
Listed drug substance patent expiration.
Nov 19, 2027
in 1 yr 5 mo
Patent 8901123 expires
Listed method-of-use patent (U-2813) expiration.
May 20, 2029
in 3 yr
Patent 8420645 expires
Listed drug substance patent expiration.
Jun 05, 2031
in 5 yr
Patent 7767675 expires
Listed drug substance patent expiration.
Nov 19, 2032
in 6 yr 6 mo
Patent 10596178 expires
Listed drug product patent expiration.
Jul 22, 2035
in 9 yr 3 mo
Patent 12208101 expires
Listed drug product patent expiration.
Jul 22, 2035
in 9 yr 3 mo
Pharmaceutical detail
Active ingredient
CAPMATINIB HYDROCHLORIDE
Strength
EQ 150MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 213591
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-291Orphan-drug exclusivity (7 years)
May 06, 2027
in 11 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12084449 | Nov 19, 2027 | in 1 yr 5 mo | U-2813 |
| 8461330 | Nov 19, 2027 | in 1 yr 5 mo | SubstanceProduct |
| 8901123 | May 20, 2029 | in 3 yr | U-2813 |
| 8420645 | Jun 05, 2031 | in 5 yr | SubstanceProduct |
| 7767675 | Nov 19, 2032 | in 6 yr 6 mo | SubstanceProduct |
| 10596178 | Jul 22, 2035 | in 9 yr 3 mo | Product |
| 12208101 | Jul 22, 2035 | in 9 yr 3 mo | Product |
