Orange Book product · Brand (NDA)
RELYVRIO
SODIUM PHENYLBUTYRATE; TAURURSODIOL
At a glance
Sep 29, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 29, 2022
3 yr 9 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 29, 2027
in 1 yr 4 mo
Exclusivity ends · ODE-411
Orphan-drug exclusivity (7 years)
Sep 29, 2029
in 3 yr 4 mo
Patent 10251896 expires
Listed method-of-use patent (U-3460) expiration.
Dec 24, 2033
in 7 yr 8 mo
Patent 10857162 expires
Listed method-of-use patent (U-3460) expiration.
Dec 24, 2033
in 7 yr 8 mo
Patent 11071742 expires
Listed drug product patent expiration.
Dec 24, 2033
in 7 yr 8 mo
Patent 9872865 expires
Listed method-of-use patent (U-3460) expiration.
Dec 24, 2033
in 7 yr 8 mo
Patent 11583542 expires
Listed drug product patent expiration.
Jul 27, 2040
in 14 yr 4 mo
Pharmaceutical detail
Active ingredient
SODIUM PHENYLBUTYRATE; TAURURSODIOL
Strength
3GM/PACKET; 1GM/PACKET
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 216660
Product number
001
Marketing status
DISCN
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 (2)
- NCENew chemical entity exclusivity (5 years)
Sep 29, 2027
in 1 yr 4 mo
- ODE-411Orphan-drug exclusivity (7 years)
Sep 29, 2029
in 3 yr 4 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10251896 | Dec 24, 2033 | in 7 yr 8 mo | U-3460 |
| 10857162 | Dec 24, 2033 | in 7 yr 8 mo | U-3460 |
| 11071742 | Dec 24, 2033 | in 7 yr 8 mo | Product |
| 9872865 | Dec 24, 2033 | in 7 yr 8 mo | U-3460 |
| 11583542 | Jul 27, 2040 | in 14 yr 4 mo | Product |
