Viewing data from:

SIGNIFOR LAR KIT

NDA

PASIREOTIDE PAMOATE | N203255 | RECORDATI RARE DISEASES INC

5 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Expiring < 1yr (2)Active (1)Today

2027

2028

Today

7473761

Dec. 14, 2026

7759308

Oct. 25, 2026

9351923

May. 23, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Signifor Lar (2023)

Total Spending

$5.8M

Total Claims

326

Beneficiaries

Avg Cost/Unit

$16975.57

Spending Trend

$1.5M(2021)→$3.7M(2022)→$5.8M(2023)

YoY Change:+10.2%

5yr CAGR:+8.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jul 15, 2024	SUPPL -11	View Letter (PDF)
Jul 10, 2020	SUPPL -8	View Letter (PDF)
Apr 15, 2019	SUPPL -7	View Letter (PDF)
Feb 13, 2019	SUPPL -5	View Letter (PDF)
Jul 6, 2018	SUPPL -4	View Letter (PDF)
Mar 15, 2018	SUPPL -2	View Letter (PDF)
Dec 16, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — EQ 20MG BASE/VIAL

RLD

3 patents0 exclusivities▴

FOR SUSPENSION;INTRAMUSCULAR | Approved: Dec 15, 2014

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7473761	Dec 14, 2026	—	Yes	Yes	—	—
7759308	Oct 25, 2026	—	—	Yes	—	—
9351923	May 23, 2028	—	—	Yes	—	—

#002 — EQ 40MG BASE/VIAL

RLD

3 patents0 exclusivities▾

FOR SUSPENSION;INTRAMUSCULAR | Approved: Dec 15, 2014

#003 — EQ 60MG BASE/VIAL

RLD

3 patents0 exclusivities▾

FOR SUSPENSION;INTRAMUSCULAR | Approved: Dec 15, 2014

#004 — EQ 10MG BASE/VIAL

RLD

3 patents0 exclusivities▾

FOR SUSPENSION;INTRAMUSCULAR | Approved: Jun 29, 2018

#005 — EQ 30MG BASE/VIAL

RLD

3 patents0 exclusivities▾

FOR SUSPENSION;INTRAMUSCULAR | Approved: Jun 29, 2018