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PROFERDEX

NDA

IRON DEXTRAN | N017807 | NEW RIVER PHARMACEUTICALS 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

3 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-6222 · 11 docket documents Law firm Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA require submission of a Prior Approval Supplement with bioequivalence testing when sponsors of carbohydrate-iron complex products such as ferric carboxymaltose, ferric derisomaltose, ferumoxytol, iron dextran	Other	2025-11-17	Open	Hyman, Phelps & McNamara, P.C.
Citizen Petition from Luitpold Pharmaceuticals, Inc. (Arent Fox) FDA-1997-P-0353 · 7 docket documents Luitpold Pharmaceuticals, Inc. filed this citizen petition requesting that the FDA withdraw approval of the intramuscular indication for INFeD (iron dextran injection) marketed by Schein Pharmaceuticals, arguing that there is no substantial evidence supporting this route of administration and that i	505(q)	2010-08-17	Denied	Luitpold Pharmaceuticals, Inc. (Arent Fox)
Luitpold Pharmaceuticals, Inc. - Citizen Petition FDA-2008-P-0524 · 5 docket documents Luitpold Pharmaceuticals, Inc. filed this citizen petition on September 23, 2008, requesting that the FDA require any new drug application (NDA) for ferumoxytol for iron deficiency anemia to contain the same rigorous clinical trial data and safety labeling as other intravenous iron dextran products,	505(q)	2008-10-02	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

13 trials from ClinicalTrials.gov, 10 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Darbepoetin Alfa With or Without Intravenous (IV) Iron NCT00401544	Phase 2	Completed	Amgen	243	2006-12 → 2008-03
Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding NCT01307007	Phase 2	Completed	American Regent, Inc.	69	2010-09 → 2013-08
Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women NCT01290315	Phase 2	Completed	American Regent, Inc.	49	2009-08 → 2013-08
Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women NCT03212781	Phase 3	Completed	Assiut University	66	2016-06 → 2016-10
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia NCT00704028	Phase 3	Completed	American Regent, Inc.	161	2008-06 → 2011-03
Lactoferrin Versus Total Dose Infusion (TDI) For Treating Iron Deficiency Anemia in Pregnancy: Role of Nursing NCT03279536	Phase 1/2	Completed	Woman's Health University Hospital, Egypt	99	2017-11-01 → 2018-12-30
Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial NCT03438227	Phase 4	Completed	Indiana University	38	2018-04-15 → 2019-12-31
Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Pregnant Women NCT02038023	Phase 2	Completed	Auerbach Hematology Oncology Associates P C	74	2013-07 → 2015-08
Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy NCT02086838	Phase 4	Completed	Ain Shams University	212	2013-07 → 2014-12
Donor Iron Deficiency Study - Red Blood Cells From Iron-deficient Donors: Recovery and Storage Quality NCT02889133	N/A	Completed	Columbia University	79	2017-01 → 2021-10-05

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

API Supply Chain5 active DMFs5 inactive

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

PHARMACOSMOS ASIRON DEXTRAN POWDER

DMF 83641989

GLAND PHARMA LTDIRON DEXTRAN COMPLEX

DMF 278232015

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDIRON DEXTRAN

DMF 292142015

MATRIX PHARMACORP PRIVATE LTDIRON DEXTRAN

DMF 333582018

MSN LIFE SCIENCES PRIVATE LTDIRON DEXTRAN

DMF 415122025

PHARMACOSMOS ASInactiveIRON DEXTRAN

DMF 16011970

FISONS LTDInactiveIRON DEXTRAN INJECTION

DMF 37741980

CHEMDEX INCInactiveIRON DEXTRAN SOLUTION 5% (50 MG/ML)

DMF 76081988

WATSON LABORATORIES INCInactiveIRON DEXTRAN, 5% SOLUTION

DMF 88081990

PHARMACHEM CORPInactiveIRON DEXTRAN

DMF 100751993

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

Products (1)

#001 — EQ 50MG IRON/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.