fulvestrant · Fresenius Kabi Usa · NDA 210326
Fulvestrant
Earliest generic entry, as listed
17 May 2034
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 9271990.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9271990 | drug product, use U-2540 · sets the listed date | 17 May 2034 |
| US 10188663 | drug product, use U-2540 | 14 Feb 2034 |
| US 9833459 | drug product, use U-2540 | 14 Feb 2034 |
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 |
|---|---|---|---|
| 210326 · 001 | solution, intramuscular | 250MG/5ML (50MG/ML) | 17 May 2034 |