gadoquatrane · Bayer Healthcare · NDA 219627
Ambelvist
Earliest generic entry, as listed · earliest of 6 marketed strengths
19 May 2040
Blocked by patent: US 11944690.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11944690 | drug product · sets the listed date | 19 May 2040 |
| US 12303573 | drug product | 21 Nov 2039 |
| US 10137209 | drug substance, use U-4424 | 30 May 2036 |
| US 10722601 | drug substance, use U-4424 | 30 May 2036 |
| US 11491245 | drug substance | 30 May 2036 |
| US 12478696 | drug substance | 30 May 2036 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 12 Jun 2031 |
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 |
|---|---|---|---|
| 219627 · 001 · RLD | solution, intravenous | 0.5158GM/2ML (257.9MG/ML) | 19 May 2040 |
| 219627 · 002 · RLD | solution, intravenous | 1.93425GM/7.5ML (257.9MG/ML) | 19 May 2040 |
| 219627 · 003 · RLD | solution, intravenous | 2.579GM/10ML (257.9MG/ML) | 19 May 2040 |
| 219627 · 004 · RLD | solution, intravenous | 3.8685GM/15ML (257.9MG/ML) | 19 May 2040 |
| 219627 · 005 · RLD | solution, intravenous | 7.737GM/30ML (257.9MG/ML) | 19 May 2040 |
| 219627 · 006 · RLD | solution, intravenous | 16.7635GM/65ML (257.9MG/ML) | 19 May 2040 |