Viewing data from:

SIGNIFOR

NDA

PASIREOTIDE DIASPARTATE | N200677 | RECORDATI RARE DISEASES INC

3 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expiring < 1yr (1)Today

2027

Today

7473761

Dec. 14, 2026

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 (2023)

Total Spending

$1.5M

Total Claims

Beneficiaries

Avg Cost/Unit

$299.60

Spending Trend

$789K(2022)→$1.5M(2023)

YoY Change:+9.3%

5yr CAGR:+9.3%

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
Jan 16, 2020	SUPPL -6	View Letter (PDF)
Apr 15, 2019	SUPPL -5	View Letter (PDF)
Feb 13, 2019	SUPPL -4	View Letter (PDF)
Mar 15, 2018	SUPPL -3	View Letter (PDF)
Mar 18, 2015	SUPPL -2	View Letter (PDF)
Feb 15, 2013	SUPPL -1	View Letter (PDF)
Dec 21, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)

RLD

1 patent0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Dec 14, 2012

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7473761	Dec 14, 2026	—	Yes	Yes	—	—

#002 — EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)

RLD

1 patent0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Dec 14, 2012

#003 — EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)

RLD

1 patent0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Dec 14, 2012