selpercatinib · Eli Lilly And Co · NDA 213246, 218160
Retevmo
Earliest generic entry, as listed · earliest of 6 marketed strengths
10 Apr 2039
Blocked by patent: US 10584124, US 10786489, US 12138250.
Listed patents · 27 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10584124 | — | 10 Apr 2039 |
| US 10786489 | — | 10 Apr 2039 |
| US 12138250 | — | 10 Apr 2039 |
| US 10584124 | substance, use U-3950 | 10 Oct 2038 |
| US 10584124 | substance, use U-3951 | 10 Oct 2038 |
| US 10584124 | substance, use U-3949 | 10 Oct 2038 |
| US 10584124 | substance, use U-3450 | 10 Oct 2038 |
| US 10786489 | product, use U-3951 | 10 Oct 2038 |
| US 10786489 | product, use U-3450 | 10 Oct 2038 |
| US 10786489 | product, use U-3949 | 10 Oct 2038 |
| US 10786489 | product, use U-3950 | 10 Oct 2038 |
| US 12138250 | use U-3949 | 10 Oct 2038 |
| US 12138250 | use U-3950 | 10 Oct 2038 |
| US 12138250 | use U-3951 | 10 Oct 2038 |
| US 12138250 | use U-3450 | 10 Oct 2038 |
| US 10112942 | — | 10 Apr 2038 |
| US 10137124 | — | 10 Apr 2038 |
| US 10172851 | — | 10 Apr 2038 |
| US 10112942 | substance, product | 10 Oct 2037 |
| US 10137124 | use U-3949 | 10 Oct 2037 |
| US 10137124 | use U-3450 | 10 Oct 2037 |
| US 10137124 | use U-3950 | 10 Oct 2037 |
| US 10137124 | use U-3951 | 10 Oct 2037 |
| US 10172851 | use U-3950 | 10 Oct 2037 |
| US 10172851 | use U-3951 | 10 Oct 2037 |
| US 10172851 | use U-3949 | 10 Oct 2037 |
| US 10172851 | use U-3450 | 10 Oct 2037 |
Exclusivities · 19 unexpired
| PED | pediatric (6 months added) | 29 Nov 2031 |
| ODE* | 29 May 2031 | |
| ODE-484 | orphan drug (7 years) | 29 May 2031 |
| ODE-485 | orphan drug (7 years) | 29 May 2031 |
| ODE-487 | orphan drug (7 years) | 29 May 2031 |
| PED | pediatric (6 months added) | 21 Mar 2030 |
| ODE* | 21 Sep 2029 | |
| ODE-412 | orphan drug (7 years) | 21 Sep 2029 |
| ODE-409 | orphan drug (7 years) | 21 Sep 2029 |
| PED | pediatric (6 months added) | 27 Mar 2028 |
| PED | pediatric (6 months added) | 29 Nov 2027 |
| PED | pediatric (6 months added) | 8 Nov 2027 |
| M-312 | miscellaneous (3 years) | 27 Sep 2027 |
| M-311 | miscellaneous (3 years) | 27 Sep 2027 |
| NPP | new patient population | 29 May 2027 |
| ODE-302 | orphan drug (7 years) | 8 May 2027 |
| ODE* | 8 May 2027 | |
| ODE-303 | orphan drug (7 years) | 8 May 2027 |
| ODE-301 | orphan drug (7 years) | 8 May 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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213246 · 001 · RLD | capsule, oral | 40MG | 10 Apr 2039 |
| 213246 · 002 · RLD | capsule, oral | 80MG | 10 Apr 2039 |
| 218160 · 001 · RLD | tablet, oral | 40MG | 10 Apr 2039 |
| 218160 · 002 · RLD | tablet, oral | 80MG | 10 Apr 2039 |
| 218160 · 003 · RLD | tablet, oral | 120MG | 10 Apr 2039 |
| 218160 · 004 · RLD | tablet, oral | 160MG | 10 Apr 2039 |