Orange Book product · Brand (NDA)
OGSIVEO
NIROGACESTAT HYDROBROMIDE
At a glance
Nov 27, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
29
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 27, 2023
2 yr 7 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 27, 2028
in 2 yr 6 mo
Patent 7795447 expires
Listed drug substance patent expiration.
Aug 18, 2030
in 4 yr 3 mo
Exclusivity ends · ODE-452
Orphan-drug exclusivity (7 years)
Nov 27, 2030
in 4 yr 6 mo
Patent 10590087 expires
Listed drug substance patent expiration.
Aug 09, 2039
in 13 yr 4 mo
Patent 10710966 expires
Listed drug substance patent expiration.
Aug 09, 2039
in 13 yr 4 mo
Patent 10941118 expires
Listed drug substance patent expiration.
Aug 09, 2039
in 13 yr 4 mo
Patent 11820748 expires
Listed drug product patent expiration.
Aug 09, 2039
in 13 yr 4 mo
Patent 11845732 expires
Listed drug substance patent expiration.
Aug 09, 2039
in 13 yr 4 mo
Patent 11884634 expires
Listed drug product patent expiration.
Aug 09, 2039
in 13 yr 4 mo
Patent 11884635 expires
Listed drug product patent expiration.
Aug 09, 2039
in 13 yr 4 mo
Patent 11905255 expires
Listed drug product patent expiration.
Aug 09, 2039
in 13 yr 4 mo
Patent 12116347 expires
Listed drug product patent expiration.
Aug 09, 2039
in 13 yr 4 mo
Patent 12297177 expires
Listed drug product patent expiration.
Aug 09, 2039
in 13 yr 4 mo
Patent 11504354 expires
Listed drug product patent expiration.
Jul 08, 2042
in 16 yr 3 mo
Patent 11612588 expires
Listed drug product patent expiration.
Jul 08, 2042
in 16 yr 3 mo
Patent 12110277 expires
Listed drug product patent expiration.
Jul 08, 2042
in 16 yr 3 mo
Patent 12234210 expires
Listed drug product patent expiration.
Jul 08, 2042
in 16 yr 3 mo
Patent 12247012 expires
Listed drug product patent expiration.
Jul 08, 2042
in 16 yr 3 mo
Patent 12599587 expires
Listed drug product patent expiration.
Jul 08, 2042
in 16 yr 3 mo
Patent 11807611 expires
Listed drug product patent expiration.
Sep 08, 2042
in 16 yr 6 mo
Patent 11844780 expires
Listed drug product patent expiration.
Sep 08, 2042
in 16 yr 6 mo
Patent 11872211 expires
Listed method-of-use patent (U-3754) expiration.
May 19, 2043
in 17 yr 2 mo
Patent 11925619 expires
Listed method-of-use patent (U-3754) expiration.
May 19, 2043
in 17 yr 2 mo
Patent 11925620 expires
Listed method-of-use patent (U-3754) expiration.
May 19, 2043
in 17 yr 2 mo
Patent 11938116 expires
Listed method-of-use patent (U-3754) expiration.
May 19, 2043
in 17 yr 2 mo
Patent 11951096 expires
Listed method-of-use patent (U-3754) expiration.
May 19, 2043
in 17 yr 2 mo
Patent 11957662 expires
Listed method-of-use patent (U-3754) expiration.
May 19, 2043
in 17 yr 2 mo
Patent 12011434 expires
Listed method-of-use patent (U-3754) expiration.
May 19, 2043
in 17 yr 2 mo
Patent 12011435 expires
Listed method-of-use patent (U-3754) expiration.
May 19, 2043
in 17 yr 2 mo
Patent 12036207 expires
Listed method-of-use patent (U-3754) expiration.
May 19, 2043
in 17 yr 2 mo
Patent 12138246 expires
Listed method-of-use patent (U-3754) expiration.
May 19, 2043
in 17 yr 2 mo
Pharmaceutical detail
Active ingredient
NIROGACESTAT HYDROBROMIDE
Strength
EQ 50MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 217677
Product number
001
Marketing status
DISCN
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)
- NCENew chemical entity exclusivity (5 years)
Nov 27, 2028
in 2 yr 6 mo
- ODE-452Orphan-drug exclusivity (7 years)
Nov 27, 2030
in 4 yr 6 mo
Listed patents (29)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7795447 | Aug 18, 2030 | in 4 yr 3 mo | Substance |
| 10590087 | Aug 09, 2039 | in 13 yr 4 mo | Substance |
| 10710966 | Aug 09, 2039 | in 13 yr 4 mo | SubstanceU-3754 |
| 10941118 | Aug 09, 2039 | in 13 yr 4 mo | SubstanceU-3754 |
| 11820748 | Aug 09, 2039 | in 13 yr 4 mo | Product |
| 11845732 | Aug 09, 2039 | in 13 yr 4 mo | SubstanceU-3754 |
| 11884634 | Aug 09, 2039 | in 13 yr 4 mo | Product |
| 11884635 | Aug 09, 2039 | in 13 yr 4 mo | Product |
| 11905255 | Aug 09, 2039 | in 13 yr 4 mo | Product |
| 12116347 | Aug 09, 2039 | in 13 yr 4 mo | Product |
| 12297177 | Aug 09, 2039 | in 13 yr 4 mo | Product |
| 11504354 | Jul 08, 2042 | in 16 yr 3 mo | Product |
| 11612588 | Jul 08, 2042 | in 16 yr 3 mo | ProductU-3754 |
| 12110277 | Jul 08, 2042 | in 16 yr 3 mo | Product |
| 12234210 | Jul 08, 2042 | in 16 yr 3 mo | Product |
| 12247012 | Jul 08, 2042 | in 16 yr 3 mo | Product |
| 12599587 | Jul 08, 2042 | in 16 yr 3 mo | Product |
| 11807611 | Sep 08, 2042 | in 16 yr 6 mo | ProductU-3754 |
| 11844780 | Sep 08, 2042 | in 16 yr 6 mo | ProductU-3754 |
| 11872211 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 11925619 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 11925620 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 11938116 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 11951096 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 11957662 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 12011434 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 12011435 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 12036207 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 12138246 | May 19, 2043 | in 17 yr 2 mo | U-3754 |

