gadopiclenol · Guerbet · NDA 216986
Elucirem
Earliest generic entry, as listed · earliest of 7 marketed strengths
17 Jan 2040
Blocked by patent: US 11590246, US 12064487.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11590246 | drug product · sets the listed date | 17 Jan 2040 |
| US 12064487 | use U-4424 · sets the listed date | 17 Jan 2040 |
| US 10973934 | drug substance | 6 Aug 2039 |
| US 8114863 | drug substance, drug product | 25 May 2032 |
Exclusivities · 2 unexpired
| NPP | new patient population | 20 Feb 2029 |
| NCE | new chemical entity (5 years) | 21 Sep 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 · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216986 · 001 · RLD | solution, intravenous | 1.4553GM/3ML (485.1MG/ML) | 17 Jan 2040 |
| 216986 · 002 · RLD | solution, intravenous | 3.63825GM/7.5ML (485.1MG/ML) | 17 Jan 2040 |
| 216986 · 003 · RLD | solution, intravenous | 4.851GM/10ML (485.1MG/ML) | 17 Jan 2040 |
| 216986 · 004 · RLD | solution, intravenous | 7.2765GM/15ML (485.1MG/ML) | 17 Jan 2040 |
| 216986 · 005 · RLD | solution, intravenous | 14.553GM/30ML (485.1MG/ML) | 17 Jan 2040 |
| 216986 · 006 · RLD | solution, intravenous | 24.255GM/50ML (485.1MG/ML) | 17 Jan 2040 |
| 216986 · 007 · RLD | solution, intravenous | 48.51GM/100ML (485.1MG/ML) | 17 Jan 2040 |