miglustat · Amicus Therap Us · NDA 215211
Opfolda
Earliest generic entry, as listed
16 Sep 2038
Blocked by patent: US 12246062. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12246062 | use U-3726 · sets the listed date | 16 Sep 2038 |
| US 10857212 | use U-3726 | 12 Aug 2037 |
| US 11278601 | drug product, use U-3726 | 29 Dec 2036 |
| US 12414985 | use U-3726 | 29 Dec 2036 |
| US 10208299 | drug substance, drug product, use U-3726 | 30 Sep 2035 |
| US 10961522 | use U-3726 | 30 Sep 2035 |
| US 11753632 | use U-3726 | 30 Sep 2035 |
| US 10512677 | use U-3726 | 7 Mar 2033 |
| US 11278599 | use U-3726 | 7 Mar 2033 |
| US 12419937 | use U-3726 | 7 Mar 2033 |
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 |
|---|---|---|---|
| 215211 · 001 · RLD | capsule, oral | 65MG | 16 Sep 2038 |
Expired or delisted (1)
- NP · 28 Sep 2026