Mallinckrodt

What Mallinckrodt does

Mallinckrodt, now operating as Keenova Therapeutics since its November 2025 rebranding, is a specialty pharmaceutical company that develops, manufactures, and commercializes branded therapeutics for rare, stigmatized, and unaddressed medical conditions. The company was originally formed as a 2013 spinoff from Covidien, headquartered in Malvern, Pennsylvania with legal domicile in Ireland. Following its July 2025 merger with Endo International ($6.7 billion) and subsequent November 2025 spin-off of its generics and sterile injectables business as Par Health, Keenova focuses on six therapeutic areas: immunology, urology, hepatology, ophthalmology, orthopedics, and critical care. The core branded portfolio includes Acthar Gel (autoimmune and inflammatory conditions, $485.7 million in FY2024 revenue with 14.2% year-over-year growth), XIAFLEX/collagenase clostridium histolyticum (the only FDA-approved nonsurgical treatment for Dupuytren's contracture and Peyronie's disease), TERLIVAZ/terlipressin (FDA-approved for hepatorenal syndrome affecting over 60,000 Americans annually), and INOmax (inhaled nitric oxide therapy supported by the next-generation Evolve DS delivery system with electronic medical record connectivity and automated calibration).

The company sells primarily through hospital systems, specialty pharmacies, and specialist healthcare providers using an enterprise field sales motion targeting immunology, urology, hepatology, and critical care specialists rather than broad consumer markets. Revenue is generated through one-time product sales at specialty pharmaceutical pricing reflecting rare-disease dynamics. Standalone FY2024 net sales reached $1.98 billion with 6.1% year-over-year growth; the combined post-merger entity projects $3.6 billion in 2025 revenue with $1.2 billion adjusted EBITDA and $150 million annual cost synergies. The company holds approximately 32% market share in the Nitric Oxide Therapy System market and has treated over 875,000 patients globally with INOmax products over 20+ years.

Keenova is led by Siggi Olafsson as President and CEO following the merger. The company emerged from Chapter 11 bankruptcy protection in 2022 after restructuring opioid-related litigation liabilities, then executed the Therakos divestiture ($925 million to CVC Capital Partners in August 2024), the Endo merger, and the Par Health spin-off to create a focused branded specialty therapeutics company preparing for NYSE listing in H2 2026. Goldman Sachs provided $900 million in committed financing for the merger transaction. The company is transitioning from its previous OTC trading symbol (MNKTQ) to a new public listing structure under the Keenova Therapeutics name.

Name

Mallinckrodt

Legal name

Keenova Therapeutics plc

Website

https://mallinckrodt.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

5,001–10,000 employees

Short description

Keenova Therapeutics (formerly Mallinckrodt) is a specialty pharmaceutical company developing branded therapeutics for rare and unaddressed conditions across immunology, urology, hepatology, and critical care, serving hospital systems, specialty pharmacies, and specialist prescribers with products including Acthar Gel, XIAFLEX, TERLIVAZ, and INOmax.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Surgical & Medical Instruments & Apparatus (3841), Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Specialty Care Pharmaceuticals (HLAIAAAB)

akta.pro secondary industries

Rare Immunology, Autoimmune & Autoinflammatory Therapies (HLAIAIAE), Immunology & Inflammation Pharmaceuticals (HLAIAAAD), Nephrology & Urology Specialty Pharmaceuticals (HLAIACAH), Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI), Gastroenterology Specialty Pharmaceuticals (HLAIACAE)

Keywords

• Specialty pharmaceuticals
• Rare disease therapeutics
• Branded drug products
• Hospital pharmaceuticals
• Drug delivery systems

Headquarters

HQ city

Blanchardstown

HQ country

Ireland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Revenue model

1. Specialty Pharmaceutical Products: Revenue from branded pharmaceutical products including Acthar Gel, XIAFLEX, Terlivaz (terlipressin), and INOmax (inhaled nitric oxide). These products target rare diseases and hospital-based therapies with pricing reflecting specialty pharmaceutical market dynamics. Fiscal 2024 net sales of $1.98 billion with 6.1% year-over-year growth.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Mallinckrodt (now Keenova Therapeutics) develops, manufactures, and commercializes branded specialty pharmaceutical products for rare, stigmatized, and unaddressed medical conditions across immunology, urology, hepatology, ophthalmology, orthopedics, and critical care. Core branded products include Acthar Gel (autoimmune/inflammatory conditions), XIAFLEX (Peyronie's disease and Dupuytren's contracture), TERLIVAZ/terlipressin (hepatorenal syndrome), and INOmax (inhaled nitric oxide for neonatal respiratory failure), supported by proprietary drug delivery systems such as the INOmax Evolve DS.

Product overview

Mallinckrodt was a global specialty pharmaceutical company that merged with Endo International in July 2025 and subsequently rebranded as Keenova Therapeutics in November 2025. Following the merger, the combined company spun off its generics and sterile injectables business as Par Health. The portfolio centered on branded specialty therapeutics includes Acthar Gel (autoimmune/inflammatory conditions), XIAFLEX (collagenase clostridium histolyticum for urology/orthopedics), TERLIVAZ (terlipressin for hepatology), and INOmax (inhaled nitric oxide for critical care/respiratory). The company also developed drug delivery systems including the INOmax Evolve DS. Therapeutic focus areas include immunology, urology, hepatology, ophthalmology, orthopedics, and critical care.

Differentiator

Problem solved

Functional benefit

Brands

• Acthar Gel: FDA-approved specialty pharmaceutical for hepatorenal syndrome and autoimmune conditions
• XIAFLEX
• TERLIVAZ (terlipressin)
• INOmax

Products and services

• Acthar Gel Specialty pharmaceutical used for treating various autoimmune and inflammatory conditions, including immunological disorders with limited treatment options.
• XIAFLEX (collagenase clostridium histolyticum) The only FDA-approved nonsurgical drug treatment for Dupuytren's contracture and Peyronie's disease.
• TERLIVAZ (terlipressin) FDA-approved drug for hepatorenal syndrome (HRS-AKI), a rare and often fatal condition affecting over 60,000 Americans annually.
• INOmax (inhaled nitric oxide) Pulmonary vasodilator used for treating term and near-term neonates with hypoxic respiratory failure, including persistent pulmonary hypertension of the newborn (PPHN).
• INOmax Evolve DS Delivery System Next-generation FDA-cleared integrated device for inhaled nitric oxide delivery to neonatal intensive care unit patients, with automated safety features, dual mini-cylinders, electronic blending, and touchscreen interface.

Quantifiable outcome

• 14.2% revenue growth for Acthar Gel in FY2024
• +2 more outcomes

Named customers2 records

Segments5 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

One partnership is on record.

• Endo InternationalflagshipStrategic or Co-development Partner · 1 August 2025Mallinckrodt and Endo completed a $6.7 billion merger on July 31, 2025. The combined entity focuses on branded specialty pharmaceuticals with Mallinckrodt CEO Siggi Olafsson leading the merged company. The transaction was one of the largest pharmaceutical mergers of 2025.

Scale indicators7 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• United Therapeutics: Specialty pharma focused on rare and serious conditions, most notably pulmonary arterial hypertension (Tyvaso, Remodulin). Direct overlap with Mallinckrodt's INOmax in critical care/respiratory and shared rare-disease commercial strategy.
• Endo International: Specialty and generics pharma that merged with Mallinckrodt in July 2025. Highly comparable in therapeutic focus (urology, endocrinology, pain), specialty/specialty injectable product mix, and prior exposure to opioid litigation.
• Recordati Rare Diseases: Specialty pharma group with a dedicated rare diseases business serving metabolic, endocrine, and urology conditions. Comparable portfolio breadth across multiple orphan indications and similar specialty distribution model.
• BioMarin Pharmaceutical: Pure-play rare disease specialty biotech commercializing enzyme replacement and gene therapies (e.g., Vimizim, Naglazyme, Roctavian). Highly comparable business model centered on small patient populations with high-priced branded therapeutics.
• Jazz Pharmaceuticals: Specialty pharmaceutical company focused on rare diseases, neuroscience, and oncology with a similar hospital/specialty pharmacy go-to-market. Comparable in product profile (Xywav, Epidiolex) and orphan/rare-disease commercial model.
• Vertex Pharmaceuticals: Specialty pharma commercializing high-priced therapies for serious diseases (cystic fibrosis, sickle cell, pain). Comparable in premium pricing for limited-population indications and hospital/specialty distribution channels.
• Swedish Orphan Biovitrum (Sobi): European specialty biopharma focused on rare diseases (haematology, immunology). Comparable specialty distribution model and parallel therapeutic areas (immunology, autoinflammatory), with similar payer engagement dynamics in rare-disease markets.
• Horizon Therapeutics (now Amgen): Pre-acquisition rare and rheumatic disease specialty pharma (Tepezza, Krystexxa). Closely matched specialty/rare-disease commercial model that motivated Amgen's $28B acquisition, illustrating the strategic premium placed on this profile.
• Ipsen: Global specialty pharma focused on oncology, rare diseases, and neuroscience (e.g., Dysport, Somatuline). Comparable specialty pharma footprint, hospital-channel sales motion, and recent rare-disease M&A activity.

Broad incumbents

• Bausch Health: Diversified specialty pharma with overlapping portfolios in gastroenterology, neurology, and dermatology. Comparable branded specialty commercial infrastructure but operates at much larger scale across therapeutic categories.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/3192

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A12 records

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Mallinckrodt