Is there a generic for Orlistat?

The FDA Orange Book does not currently list an approved generic (ANDA) for Orlistat. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Orlistat?

ALLI (NDA 021887, HALEON US HOLDINGS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Orlistat are approved?

Orlistat is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Orlistat

Orlistat is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ALLI · NDA 021887

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
ALLIRLD	HALEON US HOLDINGS	NDA 021887	—	Feb 07, 2007
XENICALRLD	CHEPLAPHARM	NDA 020766	—	Apr 23, 1999

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Orlistat — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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