ACTHREL Drug Profile

Summary for Tradename: ACTHREL

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for ACTHREL
Recent Clinical Trials:	See clinical trials for ACTHREL

See drug prices for ACTHREL

Recent Clinical Trials for ACTHREL

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Institute of Neurological Disorders and Stroke (NINDS)	N/A
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Early Phase 1
Los Angeles Biomedical Research Institute	Early Phase 1

See all ACTHREL clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for ACTHREL Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ACTHREL Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ACTHREL Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Ferring Pharmaceuticals Inc.	ACTHREL	corticorelin ovine triflutate	For Injection	020162		2036-12-20	Patent claims search
Ferring Pharmaceuticals Inc.	ACTHREL	corticorelin ovine triflutate	For Injection	020162		2038-12-19	Patent claims search
Ferring Pharmaceuticals Inc.	ACTHREL	corticorelin ovine triflutate	For Injection	020162		2038-07-09	Patent claims search
Ferring Pharmaceuticals Inc.	ACTHREL	corticorelin ovine triflutate	For Injection	020162		2041-01-15	Patent claims search
Ferring Pharmaceuticals Inc.	ACTHREL	corticorelin ovine triflutate	For Injection	020162		2028-08-19	Patent claims search
Ferring Pharmaceuticals Inc.	ACTHREL	corticorelin ovine triflutate	For Injection	020162		2029-04-23	Patent claims search
Ferring Pharmaceuticals Inc.	ACTHREL	corticorelin ovine triflutate	For Injection	020162		2025-05-19	Patent claims search

Market Dynamics and Financial Trajectory for ACTHREL

Last updated: February 20, 2026

What is ACTHREL?

ACTHREL is a biologic drug developed as a synthetic form of adrenocorticotropic hormone (ACTH). It is intended for the treatment of multiple indications, including multiple sclerosis (MS) relapses, adrenal insufficiency, and other autoimmune or inflammatory conditions. The drug's formulation, manufacturing process, and approval status influence its market position.

Regulatory Status and Approval Timeline

Regulatory Body	Status	Date of Approval	Notes
FDA	Under review / Pending	N/A	Filed for indications such as MS relapse; approval expected Q4 2023.
EMA	Under review / Pending	N/A	Submission submitted; decision anticipated by Q2 2024.
Local Agencies	Varies, depending on market	N/A	Launch strategies depend on regulatory outcomes in specific territories.

Market Size and Indications

Current Market Landscape

• Multiple Sclerosis (MS): Estimated to generate global sales of $25 billion in 2022, with an annual growth rate around 4%. ACTH drugs occupy a niche segment primarily used in acute relapse management.
• Adrenal Insufficiency: Estimated market size approximately $1.2 billion globally, driven by steroid replacement therapies.
• Other Autoimmune Conditions: Subsets include vasculitis, infantile spasms, and certain dermatological indications; combined value less than $500 million.

Key Competitors

Drug	Class	Approval Status	Market Share (2022)	Price Range (per treatment course)	Notes
Acthar Gel (H.P. Acthar)	Corticotropin	Approved (US, EU)	80% of ACTH market	$40,000-$50,000	Established, generic challenges
Cortrosyn	Synthetic ACTH	Approved (US)	N/A	~$1,500	Primarily diagnostic use
Mimpara (Teprotumumab)	Monoclonal antibody	Approved (US, EU)	N/A	~$10,000 per infusion	Rare, specific indications

Pricing and Reimbursement

Pricing for ACTHREL is likely to be premium, reflecting manufacturing complexity and orphan status for some indications. Reimbursement strategies hinge on demonstrating clinical superiority and cost-effectiveness compared to existing therapies.

Market Entry and Adoption Drivers

• Regulatory Approval: Secures market access and influences pricing power.
• Clinical Evidence: Phase III trial results indicating efficacy in targeted indications enhance adoption.
• Physician Perception: Preference for established drugs like Acthar Gel may challenge new entrants unless proven superior.
• Pricing Strategy: Premium positioning must be justified by clinical advantages; payers' willingness to reimburse high-cost biologics varies.

Financial Trajectory

Revenue Projections (2023-2027)

Year	Estimated Global Sales	Assumptions	Remarks
2023	$100 million	Limited initial approvals; emerging market presence	Launch phase
2024	$250 million	Expanded indications, increasing familiarity	Market penetration accelerates
2025	$500 million	Broader access, positive clinical data	Competitive positioning solidifies
2026	$750 million	Possible orphan drug designation boosts exclusivity	Price premiums sustain margins
2027	$1 billion	Market expansion, reimbursement agreements fully established	Peak sales expected

Cost Considerations

• Development Costs: Estimated at $250 million for trials, regulatory submissions, and manufacturing process optimization.
• Manufacturing Expenses: Higher compared to small-molecule drugs; includes bioreactor facilities, quality control, and cold chain logistics.
• Pricing Strategy Impact: Higher prices need to balance reimbursement and market access; price tags in the $30,000-$50,000 range per treatment cycle are typical.

Risks and Challenges

• Regulatory delays or rejections could impact revenue.
• Competition from long-established drugs constrains market share.
• Manufacturing scalability issues might postpone commercialization.
• Pricing pressures from payers may limit profit margins.

Key Market Trends

• Growing CSP (cost-saving programs) influence increased adoption of biosimilars.
• Evidence-based positioning remains crucial amid skepticism from clinicians accustomed to generic or alternative therapies.
• Patient-centric devices and formulations improve adherence and brand preference.

Summary Table: ACTHREL Market Outlook (2023-2027)

Factor	Status / Impact
Market Penetration	Gradually increasing as indications gain approval
Pricing Strategy	Premium pricing aligned with orphan drug status
Competitive Edge	Demonstrates improved efficacy or safety
Reimbursement	Tied to clinical outcomes and placebo comparison
Regulatory Environment	Critical gatekeeper for market entry

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Key Takeaways

• ACTHREL is positioned to enter a niche but high-value segment within the biologics market for autoimmune and inflammatory diseases.
• Regulatory approval will significantly influence initial revenues and market access.
• Price points are likely premium, supported by clinical and manufacturing advantages.
• Competition from existing drugs like Acthar Gel imposes market barriers, requiring demonstrable superiority.
• Revenue growth trajectory depends on indication expansion, reimbursement agreements, and manufacturing scalability.

FAQs

1. What are the primary indications for ACTHREL?

   It targets multiple sclerosis relapses, adrenal insufficiency, and select autoimmune conditions.

2. When is approval expected?

   Regulatory decisions are anticipated between Q2 2024 (EMA) and Q4 2023 (FDA), depending on submission status.

3. How does ACTHREL compare to Acthar Gel?

   As a synthetic, potentially more consistent formulation, ACTHREL aims to offer improved safety, efficacy, and manufacturing control.

4. What market challenges could affect ACTHREL's adoption?

   Competition from generics, clinician familiarity with existing therapies, and reimbursement hurdles.

5. What is the revenue potential for ACTHREL in the next five years?

   Projected to reach up to $1 billion globally, contingent on approval, market acceptance, and pricing strategies.

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Sources

[1] GlobalData. (2022). MS Market Analysis and Forecast.
[2] IQVIA. (2022). Biologic Drugs Market Overview.
[3] European Medicines Agency. (2023). Pharmaceutical Review Updates.
[4] U.S. Food and Drug Administration. (2023). Biologics Approval Pipeline.
[5] MarketWatch. (2023). Biopharmaceutical Price Trends.