American Regent, Inc.

Other

Pipeline Programs↗

Distinct drugs in development (Preclinical–Phase 3)

Indications↗

Distinct diseases across all programs

Clinical Trials↗

All sponsored trials (all statuses)

Orange Book Patents

Across 2 drugs with upcoming expirations

Activity

Key Events

Feb 1, 2025TrialTralement Versus a Fixed-dose Trace Element Combination Product to Evaluate Manganese Safety

Aug 1, 2024TrialTralement vs. Fixed-dose Trace Element Combination Product in Patients >3 to 17 Years of Age Requiring Long-term PN

Jul 21, 2022TrialSafety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia

Aug 30, 2021FDASelenious Acid — SELENIOUS ACID

Apr 28, 2021FDAInjectafer — INJECTAFER

Apr 15, 2020FDAGalzin — ZINC SULFATE

Nov 19, 2019TrialEfficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044

Jan 31, 2019TrialMulticenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA

2 more events

Jul 10, 2017TrialRandomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia

Mar 15, 2017TrialRandomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study

Details

Company Info

Company Overview

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Mkt Cap

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Revenue

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Cash

Patent Expirations

5 patent groups across drugs · Source: FDA Orange Book

DrugExpires

InjectaferApr 21, 2026 Injectafer5 patentsJan 8, 2027 InjectaferFeb 15, 2028 Injectafer2 patentsJul 21, 2030 Selenious Acid2 patentsJul 1, 2041

Regulatory

Regulatory Timeline

19861 event

FDAJun 26

Galzin — ZINC CHLORIDE IN PLASTIC CONTAINER

Application NDA018959 (NDA)

19871 event

FDAMay 5

Galzin — ZINC SULFATE

Application NDA019229 (NDA)

19971 event

FDAJan 28

Galzin — GALZIN

Application NDA020458 (NDA)

20051 event

FDAMar 20

Venofer — VENOFER

Application NDA021135 (NDA)

20141 event

FDASep 5

Injectafer — AURYXIA

Application NDA205874 (NDA)

20201 event

FDAApr 15

Galzin — ZINC SULFATE

Application NDA209377 (NDA)

20212 events

FDAAug 30

Selenious Acid — SELENIOUS ACID

Application NDA209379 (NDA)

FDAApr 28

Injectafer — INJECTAFER

Application NDA203565 (NDA)

Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)