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

Aug 13, 2026FDAInjectafer — INJECTAFER

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

Jan 3, 2025FDAInjectafer — INJECTAFER

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

May 31, 2023FDAInjectafer — INJECTAFER

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

Feb 4, 2022FDAInjectafer — INJECTAFER

4 more events

Nov 19, 2021FDAInjectafer — INJECTAFER

Aug 30, 2021FDASelenious Acid — SELENIOUS ACID

Aug 4, 2021FDAInjectafer — INJECTAFER

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

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

20131 event

FDAJul 25

Injectafer — INJECTAFER

Application NDA203565

20141 event

FDASep 5

Injectafer — AURYXIA

Application NDA205874 (NDA)

20152 events

FDADec 3

Injectafer — INJECTAFER

Application NDA203565

FDANov 16

Injectafer — INJECTAFER

Application NDA203565

20182 events

FDAOct 25

Injectafer — INJECTAFER

Application NDA203565

FDAJan 26

Injectafer — INJECTAFER

Application NDA203565

20204 events

FDAOct 8

Injectafer — INJECTAFER

Application NDA203565

FDASep 11

Injectafer — INJECTAFER

Application NDA203565

FDAApr 15

Galzin — ZINC SULFATE

Application NDA209377 (NDA)

FDAFeb 19

Injectafer — INJECTAFER

Application NDA203565

20215 events

FDANov 19

Injectafer — INJECTAFER

Application NDA203565

FDAAug 30

Selenious Acid — SELENIOUS ACID

Application NDA209379 (NDA)

FDAAug 4

Injectafer — INJECTAFER

Application NDA203565

FDAApr 28

Injectafer — INJECTAFER

Application NDA203565 (NDA)

FDAApr 28

Injectafer — INJECTAFER

Application NDA203565

20221 event

FDAFeb 4

Injectafer — INJECTAFER

Application NDA203565

20232 events

FDAMay 31

Injectafer — INJECTAFER

Application NDA203565

FDAMay 31

Injectafer — INJECTAFER

Application NDA203565

20251 event

FDAJan 3

Injectafer — INJECTAFER

Application NDA203565

20261 event

FDAAug 13

Injectafer — INJECTAFER

Application NDA203565

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