Orange Book product · Brand (NDA)
XERMELO
TELOTRISTAT ETIPRATE
At a glance
Feb 28, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 28, 2017
9 yr 5 mo ago
Today
Patent 7553840 expires
Listed drug substance patent expiration.
Dec 11, 2027
in 1 yr 6 mo
Patent 7968559 expires
Listed method-of-use patent (U-1979) expiration.
Dec 11, 2027
in 1 yr 6 mo
Patent 8653094 expires
Listed method-of-use patent (U-1979) expiration.
Dec 19, 2028
in 2 yr 6 mo
Patent 8193204 expires
Listed drug substance patent expiration.
Feb 27, 2031
in 4 yr 9 mo
Patent 7709493 expires
Listed drug substance patent expiration.
Feb 28, 2031
in 4 yr 9 mo
Pharmaceutical detail
Active ingredient
TELOTRISTAT ETIPRATE
Strength
EQ 250MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 208794
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7553840 | Dec 11, 2027 | in 1 yr 6 mo | Substance |
| 7968559 | Dec 11, 2027 | in 1 yr 6 mo | U-1979 |
| 8653094 | Dec 19, 2028 | in 2 yr 6 mo | U-1979 |
| 8193204 | Feb 27, 2031 | in 4 yr 9 mo | Substance |
| 7709493 | Feb 28, 2031 | in 4 yr 9 mo | SubstanceU-1979 |
