perflutren · Lantheus Medcl · NDA 021064
Definity
Earliest generic entry, as listed
4 May 2037
Blocked by patent: US 10588988. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10588988 | use U-665 | 4 May 2037 |
| US 10583208 | use U-665 | 16 Mar 2037 |
| US 11266750 | use U-665 | 16 Mar 2037 |
| US 11529431 | use U-665 | 16 Mar 2037 |
| US 11857646 | use U-665 | 16 Mar 2037 |
| US 11925695 | use U-665 | 16 Mar 2037 |
| US 12161730 | use U-665 | 16 Mar 2037 |
| US 9789210 | use U-665 | 16 Mar 2037 |
| US 10583207 | use U-665 | 28 Dec 2035 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021064 · 001 · RLD | injectable, intravenous | 13.04MG/2ML (6.52MG/ML) | 4 May 2037 |