FDA Orange Book
Is there a generic for Xermelo?
Xermelo contains telotristat etiprate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xermelo (telotristat etiprate). The Orange Book shows its last listed patent expires February 28, 2031.
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Xermelo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 250MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208794, held by TERSERA THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xermelo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7968559 | December 11, 2027 | Method of use | U-1979 | 208794 |
| 7553840 | December 11, 2027 | Drug substance | None | 208794 |
| 8653094 | December 19, 2028 | Method of use | U-1979 | 208794 |
| 8193204 | February 27, 2031 | Drug substance | None | 208794 |
| 7709493 | February 28, 2031 | Drug substance | U-1979 | 208794 |
Xermelo NDC codes
Questions
Is there a generic for Xermelo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xermelo (telotristat etiprate). The Orange Book shows its last listed patent expires February 28, 2031.
What is the generic name for Xermelo?
The active ingredient in Xermelo is telotristat etiprate, per the FDA Orange Book.
When does the Xermelo patent expire?
The last patent listed for Xermelo in the Orange Book expires February 28, 2031. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.