Mallinckrodt

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

Sep 14, 2022FDAGlypressin — TERLIVAZ

Nov 1, 2021TrialMNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function

Dec 20, 2019FDAINOmax — GENOSYL

Nov 13, 2019TrialImpact of Acthar on Everyday Life of Participants With Severe Keratitis

Dec 1, 2018TrialMNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)

Oct 5, 2018TrialSafety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)

Feb 21, 2018TrialActhar Gel in Participants With Pulmonary Sarcoidosis

Jul 27, 2017TrialRegistry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension

4 more events

Jun 22, 2017TrialStudy of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)

Mar 11, 2017TrialOpen-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients

Dec 16, 2016TrialActhar Gel for Active Systemic Lupus Erythematosus (SLE)

Nov 7, 2016TrialSafety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

Details

Company Info

Company Overview

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Mkt Cap

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Revenue

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Cash

Patent Expirations

9 patent groups across drugs · Source: FDA Orange Book

DrugExpires

INOmax3 patentsJan 18, 2026 INOmaxApr 21, 2027 INOmax17 patentsJan 28, 2029 INOmax2 patentsJun 21, 2030 INOmax16 patentsJan 6, 2031 INOmax3 patentsFeb 19, 2035 INOmax3 patentsFeb 12, 2036 GlypressinApr 5, 2037

1 more

INOmaxJul 22, 2040

Regulatory

Regulatory Timeline

19822 events

FDAJan 1

Phosphotope — PHOSPHOTOPE

Application NDA010927 (NDA)

FDAJan 1

Phosphotope — SODIUM PHOSPHATE P 32

Application NDA011777 (NDA)

19991 event

FDADec 23

INOmax — INOMAX

Application NDA020845 (NDA)

20191 event

FDADec 20

INOmax — GENOSYL

Application NDA202860 (NDA)

20221 event

FDASep 14

Glypressin — TERLIVAZ

Application NDA022231 (NDA)

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