Orange Book product · Brand (NDA)
STIVARGA
REGORAFENIB
At a glance
Sep 27, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 27, 2012
13 yr 11 mo ago
Today
Patent 8680124 expires
Listed method-of-use patent (U-1506) expiration.
Jun 02, 2030
in 4 yr
Patent 8637553 expires
Listed drug substance patent expiration.
Feb 16, 2031
in 4 yr 9 mo
Patent 9458107 expires
Listed drug product patent expiration.
Apr 08, 2031
in 4 yr 10 mo
Patent 9957232 expires
Listed drug substance patent expiration.
Jul 09, 2032
in 6 yr 2 mo
Pharmaceutical detail
Active ingredient
REGORAFENIB
Strength
40MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 203085
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.
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8680124 | Jun 02, 2030 | in 4 yr | U-1506 |
| 8637553 | Feb 16, 2031 | in 4 yr 9 mo | SubstanceProduct |
| 9458107 | Apr 08, 2031 | in 4 yr 10 mo | Product |
| 9957232 | Jul 09, 2032 | in 6 yr 2 mo | Substance |
