risedronate sodium · Apil · NDA 022560
Atelvia
Earliest generic entry, as listed
9 Jan 2028
Blocked by patent: US 7645459, US 7645460.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7645459 | drug product, use U-662 · sets the listed date | 9 Jan 2028 |
| US 7645460 | drug product, use U-662 · sets the listed date | 9 Jan 2028 |
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 |
|---|---|---|---|
| 022560 · 001 · RLD | tablet, delayed release, oral | 35MG | 9 Jan 2028 |
Expired or delisted (1)
- US 8246989 · product · 16 Jan 2026