resmetirom · Madrigal · NDA 217785
Rezdiffra
Earliest generic entry, as listed · earliest of 3 marketed strengths
4 Feb 2045
Blocked by patent: US 12377104, US 12667575. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12377104 | use U-3861 | 4 Feb 2045 |
| US 12667575 | use U-4567 | 4 Feb 2045 |
| US 12661359 | use U-4568 | 28 Jan 2042 |
| US 10376517 | use U-3861 | 17 Sep 2033 |
| US 11564926 | substance, product, use U-3861 | 17 Sep 2033 |
| US 11986481 | use U-3861 | 17 Sep 2033 |
| US 9266861 | substance, product | 17 Sep 2033 |
| US 7452882 | substance, product | 12 Sep 2027 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 14 Mar 2029 |
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 |
|---|---|---|---|
| 217785 · 001 · RLD | tablet, oral | 60MG | 4 Feb 2045 |
| 217785 · 002 · RLD | tablet, oral | 80MG | 4 Feb 2045 |
| 217785 · 003 · RLD | tablet, oral | 100MG | 4 Feb 2045 |