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FERRLECIT

NDA

SODIUM FERRIC GLUCONATE COMPLEX | N020955 | SANOFI AVENTIS US LLC

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

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 B Spending

CMS physician-administered drug spending for Ferrlecit (2023)

Total Spending

$251K

Total Claims

13,277

Beneficiaries

2,179

ASP Price

—

HCPCS: J2916 — Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain3 active DMFs3 inactive

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

BIOFER SPASODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

DMF 177462004

NAVINTA LLCSODIUM FERRIC GLUCONATE COMPLEX

DMF 185412005

MATRIX PHARMACORP PRIVATE LTDSODIUM FERRIC GLUCONATE COMPLEX

DMF 342282019

CILAG AGInactiveSODIUM FERRIC GLUCONATE

DMF 176022004

OPOCRIN SPAInactiveSODIUM FERRIC GLUCONATE

DMF 176452004

EMCURE PHARMACEUTICALS LTDInactiveSODIUM FERRIC GLUCONATE COMPLEX

DMF 219832008

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Mar 17, 2022	SUPPL -20	View Letter (PDF)
Dec 3, 2020	SUPPL -19	View Letter (PDF)
Apr 2, 2020	SUPPL -17	View Letter (PDF)
Aug 26, 2011	SUPPL -13	View Letter (PDF)
Aug 26, 2011	SUPPL -15	View Letter (PDF)
Oct 5, 2006	SUPPL -10	View Letter (PDF)
Aug 25, 2004	SUPPL -6	View Letter (PDF)
Jul 23, 2003	SUPPL -3	View Letter (PDF)
Jun 7, 2002	SUPPL -5	View Letter (PDF)
Feb 18, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)

RLDAB

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 18, 1999

No patent or exclusivity listings for this strength.