atogepant · Abbvie · NDA 215206
Qulipta
Earliest generic entry, as listed · earliest of 3 marketed strengths
29 Jul 2041
Other strengths are listed to 27 Feb 2043.
Blocked by patent: US 12090148. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12350259 | use U-4234 | 27 Feb 2043 |
| US 12465598 | use U-4355 | 27 Sep 2042 |
| US 12622897 | use U-4536 | 27 Sep 2042 |
| US 12090148 | use U-3534 · sets the listed date | 29 Jul 2041 |
| US 12383545 | use U-3534 | 6 Jun 2039 |
| US 8754096 | drug substance, drug product, use U-3534 | 28 Sep 2035 |
| US 10117836 | drug product | 30 Jan 2035 |
| US 9850246 | drug substance | 13 Mar 2033 |
| US 9499545 | drug substance, drug product, use U-3534 | 10 Nov 2031 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215206 · 001 · RLD | tablet, oral | 10MG | 27 Feb 2043 |
| 215206 · 002 · RLD | tablet, oral | 30MG | 27 Sep 2042 |
| 215206 · 003 · RLD | tablet, oral | 60MG | 29 Jul 2041 |
Expired or delisted (2)
- NCE · 28 Sep 2026
- I-909 · 17 Apr 2026