FDA Orange Book · active-ingredient family
Atogepant
Atogepant is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:QULIPTA · NDA 215206
1
Brand (NDA)
0
Generics (ANDA)
9
Listed patents
6
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| QULIPTARLD×3 | ABBVIE | NDA 215206 | — | Sep 28, 2021 |
Marketing exclusivity (6)
- I-909New indication exclusivity (3 years)
Apr 17, 2026
2 mo ago
- NCENew chemical entity exclusivity (5 years)
Sep 28, 2026
in 3 mo
- I-909New indication exclusivity (3 years)
Apr 17, 2026
2 mo ago
- NCENew chemical entity exclusivity (5 years)
Sep 28, 2026
in 3 mo
- I-909New indication exclusivity (3 years)
Apr 17, 2026
2 mo ago
- NCENew chemical entity exclusivity (5 years)
Sep 28, 2026
in 3 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9499545 | Nov 10, 2031 | in 5 yr 6 mo | SubstanceProductU-3534 |
| 9850246 | Mar 13, 2033 | in 6 yr 10 mo | Substance |
| 10117836 | Jan 30, 2035 | in 8 yr 9 mo | Product |
| 8754096 | Sep 28, 2035 | in 9 yr 5 mo | SubstanceProductU-3534 |
| 12383545 | Jun 06, 2039 | in 13 yr 2 mo | U-3534 |
| 12090148 | Jul 29, 2041 | in 15 yr 4 mo | U-3534 |
| 12465598 | Sep 27, 2042 | in 16 yr 6 mo | U-4355 |
| 12622897 | Sep 27, 2042 | in 16 yr 6 mo | U-4536 |
| 12350259 | Feb 27, 2043 | in 16 yr 11 mo | U-4234 |
Atogepant — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
