leniolisib phosphate · Pharming · NDA 217759
Joenja
Earliest generic entry, as listed · earliest of 3 marketed strengths
24 Mar 2030
Other strengths are listed to 19 Feb 2032.
Blocked by exclusivity: ODE*, ODE-430.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8653092 | drug substance, drug product | 19 Feb 2032 |
Exclusivities · 5 unexpired
| ODE* | 24 Mar 2030 | |
| ODE-430 | orphan drug (7 years) | 24 Mar 2030 |
| NS | new strength | 11 Sep 2029 |
| NPP | new patient population | 11 Sep 2029 |
| NCE | new chemical entity (5 years) | 24 Mar 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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217759 · 001 · RLD | tablet, oral | EQ 70MG BASE | 19 Feb 2032 |
| 217759 · 002 · RLD | tablet, oral | EQ 40MG BASE | 24 Mar 2030 |
| 217759 · 003 · RLD | tablet, oral | EQ 50MG BASE | 24 Mar 2030 |