FDA Orange Book · active-ingredient family
Nirogacestat hydrobromide
Nirogacestat hydrobromide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:OGSIVEO · NDA 217677
1
Brand (NDA)
0
Generics (ANDA)
29
Listed patents
6
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OGSIVEORLD×3 | SPRINGWORKS | NDA 217677 | — | Nov 27, 2023 |
Marketing exclusivity (6)
- 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
- NCENew chemical entity exclusivity (5 years)
Nov 27, 2028
in 2 yr 6 mo
- ODE*FDA marketing exclusivity
Nov 27, 2030
in 4 yr 6 mo
- NCENew chemical entity exclusivity (5 years)
Nov 27, 2028
in 2 yr 6 mo
- ODE*FDA marketing exclusivity
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 |
| 10941118 | Aug 09, 2039 | in 13 yr 4 mo | SubstanceU-3754 |
| 10710966 | Aug 09, 2039 | in 13 yr 4 mo | SubstanceU-3754 |
| 11845732 | Aug 09, 2039 | in 13 yr 4 mo | SubstanceU-3754 |
| 11884635 | Aug 09, 2039 | in 13 yr 4 mo | Product |
| 11884634 | Aug 09, 2039 | in 13 yr 4 mo | Product |
| 11905255 | Aug 09, 2039 | in 13 yr 4 mo | Product |
| 11820748 | Aug 09, 2039 | in 13 yr 4 mo | Product |
| 10590087 | Aug 09, 2039 | in 13 yr 4 mo | Substance |
| 12297177 | Aug 09, 2039 | in 13 yr 4 mo | Product |
| 12116347 | Aug 09, 2039 | in 13 yr 4 mo | Product |
| 11612588 | Jul 08, 2042 | in 16 yr 3 mo | ProductU-3754 |
| 12247012 | Jul 08, 2042 | in 16 yr 3 mo | Product |
| 12110277 | Jul 08, 2042 | in 16 yr 3 mo | Product |
| 12234210 | Jul 08, 2042 | in 16 yr 3 mo | Product |
| 12599587 | Jul 08, 2042 | in 16 yr 3 mo | Product |
| 11504354 | 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 |
| 12138246 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 12011435 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 12011434 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 11925620 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 11925619 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 11938116 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 11957662 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 11951096 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 12036207 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
| 11872211 | May 19, 2043 | in 17 yr 2 mo | U-3754 |
Nirogacestat hydrobromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
