FDA Orange Book
Is there a generic for Xenical?
Xenical contains orlistat. 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 Xenical (orlistat).
Run it in Rivvi
Map Xenical 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.
Xenical products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 120MG | Marketed (Rx) | None | 0 | None |
NDA 020766, held by CHEPLAPHARM ARZNEIMITTEL GMBH. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xenical NDC codes
Questions
Is there a generic for Xenical?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xenical (orlistat).
What is the generic name for Xenical?
The active ingredient in Xenical is orlistat, per the FDA Orange Book.
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.