lomitapide mesylate · Chiesi · NDA 203858
Juxtapid
Earliest generic entry, as listed · earliest of 5 marketed strengths
29 Jul 2041
Blocked by patent: US 12472172. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12472172 | use U-4438 | 29 Jul 2041 |
| US 7932268 | use U-1316 | 19 Aug 2027 |
Exclusivities · 2 unexpired
| NPP | new patient population | 25 Feb 2029 |
| NS | new strength | 25 Feb 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
- 24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 203858-00619 Aug 2027
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203858 · 001 · RLD | capsule, oral | EQ 5MG BASE | 29 Jul 2041 |
| 203858 · 002 · RLD | capsule, oral | EQ 10MG BASE | 29 Jul 2041 |
| 203858 · 003 · RLD | capsule, oral | EQ 20MG BASE | 29 Jul 2041 |
| 203858 · 004 · RLD | capsule, oral | EQ 30MG BASE | 29 Jul 2041 |
| 203858 · 005 · RLD · discontinued | capsule, oral | EQ 40MG BASE | 25 Feb 2029 |
| 203858 · 006 · RLD · discontinued | capsule, oral | EQ 60MG BASE | 19 Aug 2027 |
| 203858 · 007 · RLD | capsule, oral | EQ 2MG BASE | 29 Jul 2041 |