corticotropin · Mallinckrodt Ireland · NDA 008372
Acthar Gel
Earliest generic entry, as listed
18 Jul 2041
Blocked by patent: US 11752199. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
3 Orange Book listing rows for 1 patent. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11752199 | use U-3686, U-3687, U-3688 | 18 Jul 2041 |
| US 11752199 listing row | use U-3686 · sets the listed date | 18 Jul 2041 |
| US 11752199 listing row | use U-3687 · sets the listed date | 18 Jul 2041 |
| US 11752199 listing row | use U-3688 · sets the listed date | 18 Jul 2041 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 008372 · 006 · discontinued | injectable, injection | 40 UNITS/ML | open |
| 008372 · 008 · RLD | injectable, injection | 80 UNITS/ML | 18 Jul 2041 |