bosutinib monohydrate · Pf Prism Cv · NDA 203341, 217729
Bosulif
Earliest generic entry, as listed · earliest of 5 marketed strengths
28 Aug 2034
Blocked by patent: US 11103497.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11103497 | — | 28 Aug 2034 |
| US 11103497 | use U-3216 | 28 Feb 2034 |
| US 11103497 | use U-3217 | 28 Feb 2034 |
| US 7767678 | — | 23 May 2027 |
| US 7767678 | substance, product | 23 Nov 2026 |
Exclusivities · 3 unexpired
| PED | pediatric (6 months added) | 26 Mar 2031 |
| ODE-444 | orphan drug (7 years) | 26 Sep 2030 |
| PED | pediatric (6 months added) | 26 Mar 2027 |
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203341 · 001 · RLD | tablet, oral | EQ 100MG BASE | 28 Aug 2034 |
| 203341 · 002 · RLD | tablet, oral | EQ 500MG BASE | 28 Aug 2034 |
| 203341 · 003 · RLD | tablet, oral | EQ 400MG BASE | 28 Aug 2034 |
| 217729 · 001 · RLD | capsule, oral | EQ 50MG BASE | 28 Aug 2034 |
| 217729 · 002 · RLD | capsule, oral | EQ 100MG BASE | 28 Aug 2034 |
Expired or delisted (8)
- US 7417148 · — · 11 Jun 2026
- US 7919625 · — · 11 Jun 2026
- US 7417148 · use U-1283 · 11 Dec 2025
- US 7417148 · use U-3707 · 11 Dec 2025
- US 7417148 · use U-3708 · 11 Dec 2025
- US 7919625 · product · 11 Dec 2025
- I-923 · 26 Sep 2026
- NP · 26 Sep 2026