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FIRAZYR

NDA

ICATIBANT ACETATE | N022150 | TAKEDA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Firazyr (2023)

Total Spending

$56.4M

Total Claims

920

Beneficiaries

213

Avg Cost/Unit

$3762.79

Spending Trend

$132.9M(2019)→$72.6M(2020)→$61.2M(2021)→$61.6M(2022)→$56.4M(2023)

YoY Change:+0.3%

5yr CAGR:-0.1%

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

API Supply Chain16 active DMFs

16 active API suppliers hold Drug Master Files for this ingredient.

BACHEM AGICATIBANT ACETATE

DMF 208622007

CHENGDU SHENGNUO BIOPHARM CO LTDICATIBANT ACETATE

DMF 284962015

BCN PEPTIDES SAICATIBANT ACETATE

DMF 292132015

AMBIO INCICATIBANT ACETATE (NON-STERILE)

DMF 292252015

TAPI NL BVICATIBANT ACETATE

DMF 304762016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDICATIBANT ACETATE

DMF 305262016

MSN LIFE SCIENCES PRIVATE LTDICATIBANT ACETATE

DMF 306722016

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDICATIBANT ACETATE

DMF 311062016

MATRIX PHARMACORP PRIVATE LTDICATIBANT ACETATE

DMF 312602016

SUN PHARMACEUTICAL INDUSTRIES LTDICATIBANT ACETATE

DMF 315502018

DR REDDYS LABORATORIES LTDICATIBANT ACETATE

DMF 321562017

CIPLA LTDICATIBANT ACETATE

DMF 323182018

USV PRIVATE LTDICATIBANT ACETATE

DMF 332122018

AURO PEPTIDES LTDICATIBANT ACETATE

DMF 337502019

ALEMBIC PHARMACEUTICALS LTDICATIBANT ACETATE

DMF 344502020

FRESENIUS KABI IPSUM SRLICATIBANT ACETATE

DMF 381902024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jan 23, 2024	SUPPL -16	View Letter (PDF)
May 2, 2022	SUPPL -14	View Letter (PDF)
Apr 17, 2020	SUPPL -12	View Letter (PDF)
Apr 17, 2020	SUPPL -13	View Letter (PDF)
Nov 25, 2015	SUPPL -7	View Letter (PDF)
Aug 11, 2015	SUPPL -6	View Letter (PDF)
Sep 4, 2013	SUPPL -4	View Letter (PDF)
Aug 29, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

RLDAP

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Aug 25, 2011

No patent or exclusivity listings for this strength.