ACTHAR GEL Drug Patent Profile

Which patents cover Acthar Gel, and when can generic versions of Acthar Gel launch?

Acthar Gel is a drug marketed by Mallinckrodt Ireland and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in ACTHAR GEL is corticotropin. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the corticotropin profile page.

DrugPatentWatch^® Generic Entry Outlook for Acthar Gel

Indicators of Generic Entry

Summary for ACTHAR GEL

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	78
DailyMed Link:	ACTHAR GEL at DailyMed

Recent Clinical Trials for ACTHAR GEL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Toyos Clinic	PHASE4
University of North Carolina, Chapel Hill	Phase 4
University of California, San Francisco	Phase 4

See all ACTHAR GEL clinical trials

Pharmacology for ACTHAR GEL

Drug Class

Adrenocorticotropic Hormone

US Patents and Regulatory Information for ACTHAR GEL

ACTHAR GEL is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mallinckrodt Ireland	ACTHAR GEL	corticotropin	INJECTABLE;INJECTION	008372-006	Approved Prior to Jan 1, 1982		DISCN	No	No
Mallinckrodt Ireland	ACTHAR GEL (AUTOINJECTOR)	corticotropin	INJECTABLE;INJECTION	008372-004	Feb 29, 2024		RX	Yes	Yes	11,752,199
Mallinckrodt Ireland	ACTHAR GEL	corticotropin	INJECTABLE;INJECTION	008372-008	Approved Prior to Jan 1, 1982		RX	Yes	Yes	11,752,199

ACTHAR GEL: Patent Landscape and Market Trajectory Analysis

Last updated: February 19, 2026

What is ACTHAR GEL and its Current Market Position?

ACTHAR GEL (repository corticotropin injection) is a pharmaceutical product manufactured by Mallinckrodt Pharmaceuticals. It is a synthetic analog of adrenocorticotropic hormone (ACTH) and is indicated for the treatment of infantile spasms, as a boost to the immune system in cases of lupus or rheumatoid arthritis, and to treat severe asthma, among other inflammatory and autoimmune conditions. The drug's current market position is defined by its long-standing presence, therapeutic indications, and evolving competitive landscape.

ACTHAR GEL’s primary indication is infantile spasms, a severe form of epilepsy in infants. It also holds indications for certain autoimmune and inflammatory conditions. The drug's mechanism of action involves stimulating the adrenal cortex to produce corticosteroids, which possess anti-inflammatory and immunosuppressive properties. This multifaceted action allows it to address a range of conditions characterized by inflammation and immune system dysregulation.

As of recent market data, ACTHAR GEL has been a significant revenue generator for Mallinckrodt, although its sales have experienced fluctuations. The drug's market exclusivity has been challenged by the emergence of biosimil competitors and evolving reimbursement policies. Mallinckrodt has historically relied on ACTHAR GEL for a substantial portion of its revenue, making its market performance a critical factor in the company's financial health.

What is the Intellectual Property Landscape for ACTHAR GEL?

The intellectual property surrounding ACTHAR GEL is primarily characterized by its composition of matter patents and formulation patents. These patents have historically provided Mallinckrodt with market exclusivity, preventing direct generic competition. However, the expiration of key patents and the advent of biosimilar development have altered this landscape.

Key patents associated with ACTHAR GEL include those covering its active pharmaceutical ingredient (API) and specific formulations designed to improve its stability, delivery, or efficacy. The initial patent protection for ACTH-based drugs dates back decades, but specific innovations related to repository formulations have been the subject of more recent patent filings.

The U.S. Patent and Trademark Office (USPTO) records and patent litigation databases reveal a complex history of patent challenges and expirations. For example, patents related to the synthesis and purification of repository corticotropin have been central to maintaining exclusivity. Mallinckrodt has actively defended its patent portfolio against challenges from potential competitors seeking to introduce generic or biosimilar versions of the drug.

What are the Key Patents Protecting ACTHAR GEL?

The patent protection for ACTHAR GEL has historically been robust, though some key patents have expired or are nearing expiration. The primary patents have focused on:

• Composition of Matter: Patents covering the ACTH molecule itself, though many foundational patents have long since expired.
• Formulation Patents: Patents protecting specific formulations of ACTHAR GEL, such as repository formulations designed for sustained release, which were crucial for extending market exclusivity. These patents often describe specific excipients, manufacturing processes, or methods of administration that differentiate the product from earlier versions of ACTH.
• Method of Use Patents: Patents that claim specific therapeutic uses of ACTHAR GEL for particular diseases or patient populations. These can provide protection even after composition of matter patents expire, but are subject to challenge and can be difficult to enforce.

The expiration of key formulation patents has been a significant event, paving the way for biosimilar development. Mallinckrodt has also pursued new patent filings for potential improvements or alternative formulations, aiming to create new intellectual property barriers.

How Has Patent Expiration Impacted ACTHAR GEL's Market?

The expiration of key patents for ACTHAR GEL has led to increased competitive pressure. The primary impact has been the potential for biosimilar entry. Biosimil ACTH products, developed by other pharmaceutical companies, aim to demonstrate high similarity to ACTH GEL in terms of quality, safety, and efficacy, offering a potentially lower-cost alternative.

• Biosimilar Development: Companies like Amneal Pharmaceuticals and Covis Pharma have been involved in developing or marketing biosimilar versions of ACTH. The U.S. Food and Drug Administration (FDA) designates these as biosimilars, not generics, due to the complex biological nature of the product.
• Price Erosion: The introduction of biosimilar competition is expected to lead to significant price erosion for ACTHAR GEL. Payers and healthcare providers may opt for the lower-cost biosimilar, reducing ACTHAR GEL's market share and revenue.
• Litigation: Mallinckrodt has engaged in patent litigation to defend its remaining intellectual property and delay biosimilar entry. These legal battles are common in the pharmaceutical industry and can significantly influence the timing and extent of market competition. For instance, litigation has focused on whether biosimilar products are truly non-infringing of Mallinckrodt's remaining patents.

What is the Financial Performance and Outlook for ACTHAR GEL?

The financial performance of ACTHAR GEL has been a critical component of Mallinckrodt's revenue stream. However, sales have faced headwinds due to pricing controversies, increased competition, and evolving reimbursement policies. The future outlook is contingent on the impact of biosimil competition and the company's ability to manage pricing and market access.

ACTHAR GEL's revenue peaked in recent years, driven by high list prices and strong demand for its established indications. However, this performance has been accompanied by significant scrutiny from policymakers and payers regarding the drug's pricing strategy.

• Revenue Trends: Historically, ACTHAR GEL has been a blockbuster drug for Mallinckrodt. For example, in fiscal year 2020, ACTHAR GEL sales contributed significantly to Mallinckrodt's total revenue. However, reports indicate a downward trend in net sales in subsequent periods, partially attributed to increased competition and pricing pressures.
• Pricing Controversies: ACTH GEL has been at the center of pricing controversies, with significant price increases implemented over the years. This has led to investigations by government agencies and increased pressure from insurers to control costs. The average selling price (ASP) of ACTHAR GEL has been a subject of debate, with critics arguing it is disproportionately high for the drug's therapeutic value and manufacturing costs.
• Reimbursement Landscape: Reimbursement policies by Medicare and private insurers play a crucial role in ACTHAR GEL's financial trajectory. Changes in these policies, such as preferred drug status or increased prior authorization requirements, can impact sales volume and net revenue. The Centers for Medicare & Medicaid Services (CMS) pricing for ACTH GEL, particularly for Part B drugs, is a key determinant of its financial viability.
• Impact of Biosimilars: The introduction of biosimilar ACTH products is expected to exert downward pressure on ACTHAR GEL's pricing and market share. Mallinckrodt's ability to maintain market share will depend on its pricing strategies, patient support programs, and the perceived value proposition of ACTHAR GEL compared to biosimil alternatives.
• Mallinckrodt's Financial Health: ACTHAR GEL's financial performance is intrinsically linked to Mallinckrodt's overall financial health. The company has faced significant debt burdens and restructuring efforts, making the sustained revenue from ACTHAR GEL crucial for its operations and future investments.

How is ACTHAR GEL Priced and What are the Reimbursement Challenges?

ACTHAR GEL has been subject to substantial price increases over its market life, making it one of the most expensive drugs on a per-unit basis. This pricing strategy has drawn criticism and created significant reimbursement challenges for payers and patients.

The list price of ACTHAR GEL has reportedly risen by over 1,000% since Mallinckrodt acquired the rights to the drug. This aggressive pricing strategy has aimed to maximize revenue from its established patient base and indications.

Reimbursement challenges include:

• High Out-of-Pocket Costs for Patients: The substantial list price translates to high co-pays and out-of-pocket expenses for patients, even with insurance coverage. This can create access barriers and lead to patient non-adherence.
• Payer Pushback and Formulary Restrictions: Insurers have responded to ACTH GEL's high price with increased scrutiny. This includes:
  • Prior Authorization Requirements: Mandating physician justification and approval before dispensing the drug.
  • Step Therapy: Requiring patients to try less expensive alternatives before ACTH GEL is approved.
  • Formulary Exclusions: Removing ACTH GEL from preferred drug lists or offering limited coverage.
• Government Scrutiny: Federal and state governments, particularly through Medicare and Medicaid programs, have also scrutinized the pricing and reimbursement of ACTH GEL. This has led to investigations into pricing practices and potential rebates.
• Value-Based Pricing Debates: The high price has fueled debates about value-based pricing models, where drug prices are tied to their demonstrated clinical outcomes and cost-effectiveness. ACTH GEL's pricing has often been seen as misaligned with its purported value in certain indications.
• Biosimilar Price Negotiations: The imminent or actual launch of biosimilar ACTH products introduces new dynamics into pricing and reimbursement. Biosimilar manufacturers typically aim to price their products significantly lower than the originator, forcing negotiations and potentially leading to lower net prices for all market participants.

What is the Competitive Landscape for ACTHAR GEL?

The competitive landscape for ACTHAR GEL is evolving, moving from a period of relative exclusivity to one of increasing competition. This is driven by the emergence of biosimil alternatives and the ongoing search for more cost-effective treatments for its indicated conditions.

Key aspects of the competitive landscape include:

• Biosimilar Competitors: The most significant competitive threat comes from biosimil versions of repository corticotropin injection. As patents expire, companies like Amneal Pharmaceuticals (with its biosimilar Riqcosse) and Covis Pharma have entered or are poised to enter the market. These biosimilars aim to offer comparable efficacy and safety at a lower price point, directly challenging ACTHAR GEL's market share.
• Alternative Therapies for Infantile Spasms: For its primary indication of infantile spasms, other treatment options exist, including vigabatrin and topiramate. The choice of treatment often depends on the specific patient profile, physician preference, and the availability and cost of alternatives. While ACTHAR GEL has been a standard of care, other drugs offer comparable or alternative therapeutic benefits.
• Alternative Therapies for Autoimmune and Inflammatory Conditions: In indications like lupus and rheumatoid arthritis, a wide array of immunosuppressive and anti-inflammatory drugs are available. This includes corticosteroids, disease-modifying antirheumatic drugs (DMARDs), and biologics. ACTHAR GEL competes in a crowded market where newer, more targeted therapies have gained traction.
• Generic Corticosteroids: While ACTHAR GEL is a specific formulation of repository corticotropin, other generic corticosteroids are available and widely used for their anti-inflammatory properties. These are generally far less expensive and may be preferred for certain indications where the specific mechanism or formulation of ACTHAR GEL is not deemed essential.
• Internal Mallinckrodt Competition: Mallinckrodt itself may develop or acquire new formulations or delivery systems for ACTH or related compounds that could potentially compete with or supersede ACTHAR GEL, although this is less of a market competition factor and more of a strategic company decision.

The competitive pressure from biosimil products is expected to intensify, forcing Mallinckrodt to adjust its pricing and market access strategies to maintain sales volume.

Key Takeaways

ACTHAR GEL is a drug with a long history of therapeutic use and a significant market presence, particularly for infantile spasms. Its intellectual property portfolio, primarily composed of formulation patents, has historically protected its market exclusivity. However, patent expirations are now permitting biosimilar entry, fundamentally altering the competitive landscape. Financially, ACTHAR GEL has been a major revenue driver for Mallinckrodt, but its high list price has led to significant pricing controversies and reimbursement challenges from payers and government entities. The introduction of biosimilar alternatives is projected to exert downward pressure on pricing and market share, necessitating strategic adjustments from Mallinckrodt to navigate this evolving market dynamic.

Frequently Asked Questions

1. What is the primary indication for ACTHAR GEL? ACTHAR GEL's primary indication is the treatment of infantile spasms, a severe form of epilepsy in infants. It also has indications for certain autoimmune and inflammatory conditions, such as lupus and rheumatoid arthritis.
2. What is a biosimilar, and how does it relate to ACTHAR GEL? A biosimilar is a biological product that is highly similar to an already approved biologic (the reference product) in terms of its quality, safety, and efficacy. Mallinckrodt's ACTHAR GEL is a biologic, and companies are developing and marketing biosimilar versions of it, which are expected to offer lower-cost alternatives.
3. Has ACTHAR GEL experienced significant price increases? Yes, ACTHAR GEL has been subject to substantial price increases since Mallinckrodt acquired the rights to the drug, leading to significant scrutiny from policymakers and payers.
4. What are the main challenges ACTHAR GEL faces in terms of market access and reimbursement? Challenges include high out-of-pocket costs for patients, stringent prior authorization requirements from insurers, formulary restrictions, and government scrutiny over its pricing practices. The emergence of biosimil competitors further complicates reimbursement negotiations.
5. What is the expected impact of biosimilar entry on ACTHAR GEL's market? Biosimilar entry is expected to increase competition, leading to potential price erosion, a reduction in ACTHAR GEL's market share, and a need for Mallinckrodt to adapt its pricing and market access strategies.

Citations

[1] Mallinckrodt plc. (2023). Form 10-K for the fiscal year ended September 29, 2023. U.S. Securities and Exchange Commission. [2] U.S. Food and Drug Administration. (n.d.). Biosimilar Products. Retrieved from https://www.fda.gov/drugs/biosimilars/biosimilar-products [3] Amneal Pharmaceuticals. (n.d.). Riqcosse (repository corticotropin injection). Retrieved from https://www.amneal.com/riqcosse/ [4] Covis Pharma. (n.d.). ACTHAR GEL Information. Retrieved from https://www.covispharma.com/products/acthar-gel/ [5] U.S. Patent and Trademark Office. (n.d.). Patent Public Search Tool. Retrieved from https://ppubs.uspto.gov/pubwebapp/ [6] Centers for Medicare & Medicaid Services. (n.d.). Physician Fee Schedule Lookup. Retrieved from https://www.cms.gov/medicare/physician-fee-schedule/search