ospemifene · Duchesnay · NDA 203505
Osphena
Earliest generic entry, as listed
9 Jul 2028
Blocked by patent: US 8642079.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8642079 | product | 9 Jul 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 |
|---|---|---|---|
| 203505 · 001 · RLD | tablet, oral | 60MG | 9 Jul 2028 |
Expired or delisted (3)
- US 8236861 · use U-905 · 11 Aug 2026
- US 8236861 · use U-1369 · 11 Aug 2026
- US 8236861 · use U-1370 · 11 Aug 2026