Is there a generic for Lanreotide acetate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Lanreotide acetate, referencing the brand LANREOTIDE ACETATE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Lanreotide acetate?

LANREOTIDE ACETATE (NDA 215395, INVAGEN PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Lanreotide acetate are approved?

Lanreotide acetate is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Lanreotide acetate

Lanreotide acetate is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LANREOTIDE ACETATE · NDA 215395

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
LANREOTIDE ACETATERLD×3	INVAGEN PHARMS	NDA 215395	—	Dec 17, 2021
SOMATULINE DEPOTRLD×3	IPSEN PHARMA	NDA 022074	AB	Aug 30, 2007

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
LANREOTIDE ACETATE×3	INVAGEN PHARMS	ANDA 217193	AB	May 21, 2024

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.

Lanreotide acetate — frequently asked questions

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

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