FDA Orange Book · active-ingredient family
Telotristat etiprate
Telotristat etiprate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:XERMELO · NDA 208794
1
Brand (NDA)
0
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XERMELORLD | TERSERA | NDA 208794 | — | Feb 28, 2017 |
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7968559 | Dec 11, 2027 | in 1 yr 6 mo | U-1979 |
| 7553840 | Dec 11, 2027 | in 1 yr 6 mo | Substance |
| 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 |
Telotristat etiprate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
