Orange Book product · Brand (NDA)
OCALIVA
OBETICHOLIC ACID
At a glance
May 27, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 27, 2016
10 yr 3 mo ago
Today
Patent RE48286 expires
Listed drug substance patent expiration.
Feb 21, 2027
in 8 mo
Patent 10174073 expires
Listed drug substance patent expiration.
Jun 17, 2033
in 7 yr 1 mo
Patent 9238673 expires
Listed drug product patent expiration.
Jun 17, 2033
in 7 yr 1 mo
Patent 10047117 expires
Listed method-of-use patent (U-1854) expiration.
Sep 06, 2033
in 7 yr 4 mo
Patent 10052337 expires
Listed drug product patent expiration.
Apr 26, 2036
in 10 yr
Patent 10751349 expires
Listed drug product patent expiration.
Apr 26, 2036
in 10 yr
Patent 10758549 expires
Listed method-of-use patent (U-2945) expiration.
Apr 26, 2036
in 10 yr
Pharmaceutical detail
Active ingredient
OBETICHOLIC ACID
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 207999
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.
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE48286 | Feb 21, 2027 | in 8 mo | SubstanceProduct |
| 10174073 | Jun 17, 2033 | in 7 yr 1 mo | Substance |
| 9238673 | Jun 17, 2033 | in 7 yr 1 mo | Product |
| 10047117 | Sep 06, 2033 | in 7 yr 4 mo | U-1854 |
| 10052337 | Apr 26, 2036 | in 10 yr | Product |
| 10751349 | Apr 26, 2036 | in 10 yr | Product |
| 10758549 | Apr 26, 2036 | in 10 yr | U-2945 |
