FDA Orange Book · active-ingredient family
Pirtobrutinib
Pirtobrutinib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:JAYPIRCA · NDA 216059
1
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
10
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| JAYPIRCARLD×2 | LOXO ONCOL | NDA 216059 | — | Jan 27, 2023 |
Marketing exclusivity (10)
- I-981New indication exclusivity (3 years)
Dec 02, 2028
in 2 yr 6 mo
- NCENew chemical entity exclusivity (5 years)
Jan 27, 2028
in 1 yr 8 mo
- ODE-424Orphan-drug exclusivity (7 years)
Jan 27, 2030
in 3 yr 8 mo
- ODE-451Orphan-drug exclusivity (7 years)
Dec 01, 2030
in 4 yr 6 mo
- ODE-518Orphan-drug exclusivity (7 years)
Dec 03, 2032
in 6 yr 7 mo
- I-981New indication exclusivity (3 years)
Dec 02, 2028
in 2 yr 6 mo
- NCENew chemical entity exclusivity (5 years)
Jan 27, 2028
in 1 yr 8 mo
- ODE-424Orphan-drug exclusivity (7 years)
Jan 27, 2030
in 3 yr 8 mo
- ODE-451Orphan-drug exclusivity (7 years)
Dec 01, 2030
in 4 yr 6 mo
- ODE-518Orphan-drug exclusivity (7 years)
Dec 03, 2032
in 6 yr 7 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10918622 | Dec 16, 2036 | in 10 yr 8 mo | U-3518 |
| 10695323 | Dec 16, 2036 | in 10 yr 8 mo | SubstanceProductU-3518 |
| 10464905 | Dec 16, 2036 | in 10 yr 8 mo | U-3518 |
| 12220401 | Dec 16, 2036 | in 10 yr 8 mo | SubstanceProductU-3518 |
| 10342780 | Dec 16, 2036 | in 10 yr 8 mo | SubstanceProduct |
| 12268666 | Jul 29, 2039 | in 13 yr 4 mo | Product |
| 12109193 | Sep 14, 2041 | in 15 yr 6 mo | Product |
Pirtobrutinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
