Orange Book product · Brand (NDA)
BYLVAY
ODEVIXIBAT
At a glance
Jul 20, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
28
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 20, 2021
5 yr ago
Exclusivity ends · I-918
New indication exclusivity (3 years)
Jun 13, 2026
6 d ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jul 20, 2026
in 1 mo
Exclusivity ends · ODE-363
Orphan-drug exclusivity (7 years)
Jul 20, 2028
in 2 yr 1 mo
Exclusivity ends · ODE-436
Orphan-drug exclusivity (7 years)
Jun 13, 2030
in 4 yr 1 mo
Patent 10011633 expires
Listed method-of-use patent (U-3186) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 10011633 expires
Listed method-of-use patent (U-3648) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 10093697 expires
Listed method-of-use patent (U-3186) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 10093697 expires
Listed method-of-use patent (U-3648) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 10487111 expires
Listed method-of-use patent (U-3186) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 10487111 expires
Listed method-of-use patent (U-3648) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 10981952 expires
Listed method-of-use patent (U-3186) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 10981952 expires
Listed method-of-use patent (U-3187) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 10981952 expires
Listed method-of-use patent (U-3649) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 10981952 expires
Listed method-of-use patent (U-3648) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 11732006 expires
Listed method-of-use patent (U-3648) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 11732006 expires
Listed method-of-use patent (U-3186) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 12187812 expires
Listed method-of-use patent (U-3186) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 12187812 expires
Listed method-of-use patent (U-3648) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 12545705 expires
Listed method-of-use patent (U-3186) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 12545705 expires
Listed method-of-use patent (U-3648) expiration.
Nov 08, 2031
in 5 yr 6 mo
Patent 9694018 expires
Listed method-of-use patent (U-3186) expiration.
Mar 18, 2034
in 7 yr 10 mo
Patent 9694018 expires
Listed method-of-use patent (U-3648) expiration.
Mar 18, 2034
in 7 yr 10 mo
Patent 10975046 expires
Listed drug substance patent expiration.
Jun 20, 2039
in 13 yr 2 mo
Patent 11365182 expires
Listed method-of-use patent (U-3648) expiration.
Jun 20, 2039
in 13 yr 2 mo
Patent 11365182 expires
Listed method-of-use patent (U-3186) expiration.
Jun 20, 2039
in 13 yr 2 mo
Patent 11801226 expires
Listed drug product patent expiration.
Jun 20, 2039
in 13 yr 2 mo
Patent 11802115 expires
Listed drug product patent expiration.
Jun 20, 2039
in 13 yr 2 mo
Patent 12091394 expires
Listed drug substance patent expiration.
Jun 20, 2039
in 13 yr 2 mo
Patent 12508234 expires
Listed method-of-use patent (U-3648) expiration.
Jun 20, 2039
in 13 yr 2 mo
Patent 12508234 expires
Listed method-of-use patent (U-3186) expiration.
Jun 20, 2039
in 13 yr 2 mo
Patent 11583539 expires
Listed method-of-use patent (U-3186) expiration.
Nov 12, 2041
in 15 yr 8 mo
Patent 12447156 expires
Listed method-of-use patent (U-3186) expiration.
Nov 12, 2041
in 15 yr 8 mo
Pharmaceutical detail
Active ingredient
ODEVIXIBAT
Strength
0.4MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 215498
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (4)
- 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 (28)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10011633 | Nov 08, 2031 | in 5 yr 6 mo | U-3186 |
| 10011633 | Nov 08, 2031 | in 5 yr 6 mo | U-3648 |
| 10093697 | Nov 08, 2031 | in 5 yr 6 mo | U-3186 |
| 10093697 | Nov 08, 2031 | in 5 yr 6 mo | U-3648 |
| 10487111 | Nov 08, 2031 | in 5 yr 6 mo | U-3186 |
| 10487111 | Nov 08, 2031 | in 5 yr 6 mo | U-3648 |
| 10981952 | Nov 08, 2031 | in 5 yr 6 mo | U-3186 |
| 10981952 | Nov 08, 2031 | in 5 yr 6 mo | U-3187 |
| 10981952 | Nov 08, 2031 | in 5 yr 6 mo | U-3649 |
| 10981952 | Nov 08, 2031 | in 5 yr 6 mo | U-3648 |
| 11732006 | Nov 08, 2031 | in 5 yr 6 mo | U-3648 |
| 11732006 | Nov 08, 2031 | in 5 yr 6 mo | U-3186 |
| 12187812 | Nov 08, 2031 | in 5 yr 6 mo | U-3186 |
| 12187812 | Nov 08, 2031 | in 5 yr 6 mo | U-3648 |
| 12545705 | Nov 08, 2031 | in 5 yr 6 mo | U-3186 |
| 12545705 | Nov 08, 2031 | in 5 yr 6 mo | U-3648 |
| 9694018 | Mar 18, 2034 | in 7 yr 10 mo | U-3186 |
| 9694018 | Mar 18, 2034 | in 7 yr 10 mo | U-3648 |
| 10975046 | Jun 20, 2039 | in 13 yr 2 mo | Substance |
| 11365182 | Jun 20, 2039 | in 13 yr 2 mo | U-3648 |
| 11365182 | Jun 20, 2039 | in 13 yr 2 mo | U-3186 |
| 11801226 | Jun 20, 2039 | in 13 yr 2 mo | Product |
| 11802115 | Jun 20, 2039 | in 13 yr 2 mo | Product |
| 12091394 | Jun 20, 2039 | in 13 yr 2 mo | Substance |
| 12508234 | Jun 20, 2039 | in 13 yr 2 mo | U-3648 |
| 12508234 | Jun 20, 2039 | in 13 yr 2 mo | U-3186 |
| 11583539 | Nov 12, 2041 | in 15 yr 8 mo | U-3186 |
| 12447156 | Nov 12, 2041 | in 15 yr 8 mo | U-3186 |
