FDA Orange Book · active-ingredient family
Crofelemer
Crofelemer is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:MYTESI · NDA 202292
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MYTESIRLD | NAPO PHARMS INC | NDA 202292 | — | Dec 31, 2012 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9585868 | Oct 31, 2031 | in 5 yr 5 mo | U-1319 |
| 8962680 | Oct 31, 2031 | in 5 yr 5 mo | U-1319 |
Crofelemer — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
