FDA Orange Book
Is there a generic for Mytesi?
Mytesi contains crofelemer. 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 Mytesi (crofelemer). The Orange Book shows its last listed patent expires October 31, 2031.
Run it in Rivvi
Map Mytesi and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Mytesi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, delayed release, oral | 125MG | Marketed (Rx) | None | 0 | None |
NDA 202292, held by NAPO PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Mytesi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9585868 | October 31, 2031 | Method of use | U-1319 | 202292 |
| 8962680 | October 31, 2031 | Method of use | U-1319 | 202292 |
Mytesi NDC codes
Questions
Is there a generic for Mytesi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Mytesi (crofelemer). The Orange Book shows its last listed patent expires October 31, 2031.
What is the generic name for Mytesi?
The active ingredient in Mytesi is crofelemer, per the FDA Orange Book.
When does the Mytesi patent expire?
The last patent listed for Mytesi in the Orange Book expires October 31, 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.