Orange Book product · Brand (NDA)
ISTURISA
OSILODROSTAT PHOSPHATE
At a glance
Mar 06, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 06, 2020
6 yr 5 mo ago
Today
Patent 8835646 expires
Listed drug substance patent expiration.
Aug 23, 2026
in 2 mo
Exclusivity ends · ODE-286
Orphan-drug exclusivity (7 years)
Mar 06, 2027
in 9 mo
Patent 8609862 expires
Listed method-of-use patent (U-4177) expiration.
Jan 13, 2031
in 4 yr 8 mo
Patent 8609862 expires
Listed method-of-use patent (U-2770) expiration.
Jan 13, 2031
in 4 yr 8 mo
Patent 8609862 expires
Listed method-of-use patent (U-4529) expiration.
Jan 13, 2031
in 4 yr 8 mo
Patent 9434754 expires
Listed drug substance patent expiration.
Jan 13, 2031
in 4 yr 8 mo
Exclusivity ends · ODE-535
Orphan-drug exclusivity (7 years)
Apr 15, 2032
in 5 yr 11 mo
Patent 8314097 expires
Listed drug substance patent expiration.
May 20, 2033
in 7 yr
Patent 10143680 expires
Listed drug product patent expiration.
Jul 06, 2035
in 9 yr 2 mo
Patent 10709691 expires
Listed method-of-use patent (U-4177) expiration.
Oct 12, 2035
in 9 yr 5 mo
Patent 10709691 expires
Listed method-of-use patent (U-2770) expiration.
Oct 12, 2035
in 9 yr 5 mo
Patent 10709691 expires
Listed method-of-use patent (U-4529) expiration.
Oct 12, 2035
in 9 yr 5 mo
Pharmaceutical detail
Active ingredient
OSILODROSTAT PHOSPHATE
Strength
EQ 1MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 212801
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 (2)
- ODE-286Orphan-drug exclusivity (7 years)
Mar 06, 2027
in 9 mo
- ODE-535Orphan-drug exclusivity (7 years)
Apr 15, 2032
in 5 yr 11 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8835646 | Aug 23, 2026 | in 2 mo | SubstanceProduct |
| 8609862 | Jan 13, 2031 | in 4 yr 8 mo | U-4177 |
| 8609862 | Jan 13, 2031 | in 4 yr 8 mo | U-2770 |
| 8609862 | Jan 13, 2031 | in 4 yr 8 mo | U-4529 |
| 9434754 | Jan 13, 2031 | in 4 yr 8 mo | Substance |
| 8314097 | May 20, 2033 | in 7 yr | SubstanceProduct |
| 10143680 | Jul 06, 2035 | in 9 yr 2 mo | Product |
| 10709691 | Oct 12, 2035 | in 9 yr 5 mo | U-4177 |
| 10709691 | Oct 12, 2035 | in 9 yr 5 mo | U-2770 |
| 10709691 | Oct 12, 2035 | in 9 yr 5 mo | U-4529 |
