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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

No clinical trials found on ClinicalTrials.gov for this drug

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)

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