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ACCRUFER

NDA

FERRIC MALTOL | N212320 | SHIELD TX UK LTD

1 strength3 unique patents1 unique exclusivity

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Active (3)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

9248148

Mar. 29, 2031

9802973

Oct. 23, 2035

10179120

Jan. 6, 2035

NPP

Dec. 19, 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

7 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)NCT01340872	Phase 3	Completed	Shield Therapeutics	128	2011-08 → 2014-10
Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's Disease (AEGIS-2)NCT01352221	Phase 3	Completed	Shield Therapeutics	128	2011-08 → 2014-10
Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD NCT02680756	Phase 3	Completed	Shield Therapeutics	250	2016-01 → 2019-01
Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency NCT03181451	Phase 1	Completed	Shield Therapeutics	37	2017-03-14 → 2018-03-28
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease NCT02968368	Phase 3	Completed	Shield Therapeutics	167	2016-12-01 → 2018-10-10
ORal IrON Supplementation With Ferric Maltol in Patients With Pulmonary Hypertension (ORION-PH-1)NCT03371173	Phase 3	Terminated	Hannover Medical School	22	2018-03-27 → 2020-03-19
ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices NCT03774615	Phase 4	Terminated	Hannover Medical School	11	2019-03-18 → 2019-11-29

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$10.09

per ea

Lowest NADAC/Unit

$10.09

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
73059000160ACCRUFER 30 MG CAPSULE	$10.09	EA	Brand	—	2026-07-01

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$423.91

Highest Price

$489.43

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
73059-0001-60ACCRUFER 30 MG CAPSULE	$489.43	FSS	Shield Therapeutics, Inc.	03/14/2027
73059-0001-60ACCRUFER 30 MG CAPSULE	$423.91	Big4	Shield Therapeutics, Inc.	03/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

GTZ (INDIA) PRIVATE LTDFERRIC MALTOL

DMF 422692025

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Dec 23, 2025	SUPPL -19	View Letter (PDF)
Sep 9, 2022	SUPPL -15	View Letter (PDF)
Jun 2, 2022	SUPPL -13	View Letter (PDF)
Feb 17, 2022	SUPPL -11	View Letter (PDF)
Nov 2, 2020	SUPPL -5	View Letter (PDF)
Jul 26, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 30MG IRON

RLD

3 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Jul 25, 2019

Patents (3) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
9248148	Mar 29, 2031	—	—	—	—
9802973	Oct 23, 2035	—	Yes	Yes	—
10179120	Jan 6, 2035	—	—	—	—

Exclusivities (1)

Code	Date	Status
NPP	Dec 19, 2028	Active