Orange Book product · Brand (NDA)

SIGNIFOR LAR KIT

PASIREOTIDE PAMOATE

Brand (NDA)NDA 203255RX RECORDATI RARE

Jun 29, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 29, 2018
8 yr 1 mo ago
Today
Patent 7759308 expires
Listed drug product patent expiration.
Oct 25, 2026
in 4 mo
Patent 7473761 expires
Listed drug substance patent expiration.
Dec 14, 2026
in 6 mo
Patent 9351923 expires
Listed drug product patent expiration.
May 23, 2028
in 1 yr 11 mo

Active ingredient

PASIREOTIDE PAMOATE

Strength

EQ 30MG BASE/VIAL

Dosage form

FOR SUSPENSION

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 203255

Product number

005

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
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