pirtobrutinib · Loxo Oncol · NDA 216059
Jaypirca
Earliest generic entry, as listed · earliest of 2 marketed strengths
14 Sep 2041
Blocked by patent: US 12109193.
Listed patents · 11 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12109193 | product | 14 Sep 2041 |
| US 12268666 | product | 29 Jul 2039 |
| US 10342780 | substance, product | 16 Dec 2036 |
| US 10464905 | use U-4362 | 16 Dec 2036 |
| US 10464905 | use U-3518 | 16 Dec 2036 |
| US 10695323 | substance, product, use U-3518 | 16 Dec 2036 |
| US 10695323 | substance, product, use U-4362 | 16 Dec 2036 |
| US 10918622 | use U-4362 | 16 Dec 2036 |
| US 10918622 | use U-3518 | 16 Dec 2036 |
| US 12220401 | substance, product, use U-4362 | 16 Dec 2036 |
| US 12220401 | substance, product, use U-3518 | 16 Dec 2036 |
Exclusivities · 5 unexpired
| ODE-518 | orphan drug (7 years) | 3 Dec 2032 |
| ODE-451 | orphan drug (7 years) | 1 Dec 2030 |
| ODE-424 | orphan drug (7 years) | 27 Jan 2030 |
| I-981 | new indication (3 years) | 2 Dec 2028 |
| NCE | new chemical entity (5 years) | 27 Jan 2028 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216059 · 001 · RLD | tablet, oral | 50MG | 14 Sep 2041 |
| 216059 · 002 · RLD | tablet, oral | 100MG | 14 Sep 2041 |