FDA Orange Book · active-ingredient family
Odevixibat
Odevixibat is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:BYLVAY · NDA 215498
1
Brand (NDA)
0
Generics (ANDA)
16
Listed patents
16
Exclusivity periods
Brand (NDA) products · capsule, capsule, pellets
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BYLVAYRLD×4 | IPSEN | NDA 215498 | — | Jul 20, 2021 |
Marketing exclusivity (16)
- I-918New indication exclusivity (3 years)
Jun 13, 2026
6 d ago
- NCENew chemical entity exclusivity (5 years)
Jul 20, 2026
in 1 mo
- ODE-363Orphan-drug exclusivity (7 years)
Jul 20, 2028
in 2 yr 1 mo
- ODE-436Orphan-drug exclusivity (7 years)
Jun 13, 2030
in 4 yr 1 mo
- I-918New indication exclusivity (3 years)
Jun 13, 2026
6 d ago
- NCENew chemical entity exclusivity (5 years)
Jul 20, 2026
in 1 mo
- ODE-363Orphan-drug exclusivity (7 years)
Jul 20, 2028
in 2 yr 1 mo
- ODE-436Orphan-drug exclusivity (7 years)
Jun 13, 2030
in 4 yr 1 mo
- I-918New indication exclusivity (3 years)
Jun 13, 2026
6 d ago
- NCENew chemical entity exclusivity (5 years)
Jul 20, 2026
in 1 mo
- ODE-363Orphan-drug exclusivity (7 years)
Jul 20, 2028
in 2 yr 1 mo
- ODE-436Orphan-drug exclusivity (7 years)
Jun 13, 2030
in 4 yr 1 mo
- I-918New indication exclusivity (3 years)
Jun 13, 2026
6 d ago
- NCENew chemical entity exclusivity (5 years)
Jul 20, 2026
in 1 mo
- ODE-363Orphan-drug exclusivity (7 years)
Jul 20, 2028
in 2 yr 1 mo
- ODE-436Orphan-drug exclusivity (7 years)
Jun 13, 2030
in 4 yr 1 mo
Listed patents (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12545705 | Nov 08, 2031 | in 5 yr 6 mo | U-3186 |
| 10487111 | Nov 08, 2031 | in 5 yr 6 mo | U-3186 |
| 10981952 | Nov 08, 2031 | in 5 yr 6 mo | U-3187 |
| 10011633 | Nov 08, 2031 | in 5 yr 6 mo | U-3186 |
| 10093697 | Nov 08, 2031 | in 5 yr 6 mo | U-3186 |
| 11732006 | Nov 08, 2031 | in 5 yr 6 mo | U-3648 |
| 12187812 | Nov 08, 2031 | in 5 yr 6 mo | U-3186 |
| 9694018 | Mar 18, 2034 | in 7 yr 10 mo | U-3186 |
| 12508234 | Jun 20, 2039 | in 13 yr 2 mo | U-3186 |
| 11365182 | Jun 20, 2039 | in 13 yr 2 mo | U-3648 |
| 11801226 | Jun 20, 2039 | in 13 yr 2 mo | Product |
| 12091394 | Jun 20, 2039 | in 13 yr 2 mo | Substance |
| 11802115 | Jun 20, 2039 | in 13 yr 2 mo | Product |
| 10975046 | Jun 20, 2039 | in 13 yr 2 mo | Substance |
| 12447156 | Nov 12, 2041 | in 15 yr 8 mo | U-3186 |
| 11583539 | Nov 12, 2041 | in 15 yr 8 mo | U-3186 |
Odevixibat — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
