florbetapir f-18 · Avid Radiopharms Inc · NDA 202008
Amyvid
Earliest generic entry, as listed · earliest of 2 marketed strengths
30 Apr 2027
Blocked by patent: US 7687052, US 8506929.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7687052 | drug substance, drug product, use U-4217 · sets the listed date | 30 Apr 2027 |
| US 8506929 | drug substance, drug product, use U-4217 · sets the listed date | 30 Apr 2027 |
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
- Enters 12-month window basis: patent · 202008-003Listed date 30 Apr 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 202008-002Listed date 30 Apr 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 202008-004Listed date 30 Apr 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 202008-001Listed date 30 Apr 2027Detected 24 Oct 2026
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202008 · 001 · RLD · discontinued | solution, intravenous | 10ML (13.5-51mCi/ML) | 30 Apr 2027 |
| 202008 · 002 · RLD · discontinued | solution, intravenous | 10-30ML (13.5-51mCi/ML) | 30 Apr 2027 |
| 202008 · 003 · RLD | solution, intravenous | 10-50ML (13.5-51mCi/ML) | 30 Apr 2027 |
| 202008 · 004 · RLD | solution, intravenous | 10-100ML (13.5-51mCi/ML) | 30 Apr 2027 |