Question 1

Is there a generic for Pasireotide pamoate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Pasireotide pamoate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Pasireotide pamoate?

Accepted Answer

SIGNIFOR LAR KIT (NDA 203255, RECORDATI RARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Pasireotide pamoate?

Accepted Answer

The Orange Book lists 3 patents against Pasireotide pamoate products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Pasireotide pamoate are approved?

Accepted Answer

Pasireotide pamoate is approved in the following dosage form: for suspension.

Patent	Expires	In	Type
7759308	Oct 25, 2026	in 4 mo	Product
7473761	Dec 14, 2026	in 6 mo	SubstanceProduct
9351923	May 23, 2028	in 1 yr 11 mo	Product

Pasireotide pamoate

Brand (NDA) products · for suspension

Listed patents (3)

Pasireotide pamoate — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.