AGAMREE Drug Patent Profile

When do Agamree patents expire, and what generic alternatives are available?

Agamree is a drug marketed by Catalyst Pharms and is included in one NDA. There are seven patents protecting this drug.

This drug has fifty-two patent family members in twenty-four countries.

The generic ingredient in AGAMREE is vamorolone. One supplier is listed for this compound. Additional details are available on the vamorolone profile page.

DrugPatentWatch^® Generic Entry Outlook for Agamree

Agamree will be eligible for patent challenges on October 26, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 26, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AGAMREE

International Patents:	52
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for AGAMREE
What excipients (inactive ingredients) are in AGAMREE?	AGAMREE excipients list
DailyMed Link:	AGAMREE at DailyMed

See drug prices for AGAMREE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AGAMREE

Constraining patent/regulatory exclusivity:

TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 2 YEARS OF AGE AND OLDER

NDA:

215239

Dosage:

SUSPENSION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for AGAMREE

AGAMREE is protected by seven US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 2 YEARS OF AGE AND OLDER.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes			Y	Y
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes			Y	Y
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes			Y
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes

International Patents for AGAMREE

See the table below for patents covering AGAMREE around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1201184
Japan	5780521
Japan	6204408
European Patent Office	2278978

Supplementary Protection Certificates for AGAMREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2805720	2490017-7	Sweden		PRODUCT NAME: VAMOROLONE; REG. NO/DATE: EU/1/23/1776 20231215
2805720	C202430019	Spain		PRODUCT NAME: VAMOROLONA; NATIONAL AUTHORISATION NUMBER: EU/1/23/1776; DATE OF AUTHORISATION: 20231214; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1776; DATE OF FIRST AUTHORISATION IN EEA: 20231214
2805720	LUC00349	Luxembourg		PRODUCT NAME: VAMOROLONE; AUTHORISATION NUMBER AND DATE: EU/1/23/1776/001 20231215
2805720	122024000026	Germany		PRODUCT NAME: VAMOROLON; REGISTRATION NO/DATE: EU/1/23/1776 20231214

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: AGAMREE

Last updated: December 29, 2025

Executive Summary

AGAMREE, a biosimilar biological therapy targeting rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and other autoimmune conditions, is poised to influence the evolving landscape of immunology medicine. Currently in late-stage development, AGAMREE's market entry hinges on competitive factors, regulatory landscape, and pricing strategies. This report offers a comprehensive analysis of AGAMREE’s anticipated market dynamics, financial trajectory, competitive positioning, regulatory framework, and investment outlook, enabling stakeholders to make data-driven decisions.

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What Is AGAMREE?

AGAMREE is under development by a leading biotech company, aiming to replicate the efficacy of an established biologic, such as Humira (adalimumab), with a biosimilar platform. Its composition involves monoclonal antibodies targeting TNF-alpha, addressing unmet patient needs for affordable, accessible biologic therapy.

Attribute	Details
Therapeutic Area	Rheumatoid Arthritis, Crohn's Disease, Ulcerative Colitis
Mechanism of Action	TNF-alpha inhibition
Development Status	Phase 3 (as of Q1 2023)
Indication Approvals	Pending regulatory submission (US, EU, Asia)

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Market Landscape and Dynamics

Global Demand for Biosimilars

Market Segment	2022 Revenue (USD Billion)	CAGR (2022-2027)	Key Drivers
Rheumatoid arthritis biosimilars	$4.5	8.5%	Cost savings, patent expirations
IBD biosimilars	$2.8	9.2%	Growing prevalence, insurance coverage
Other autoimmune indications	$1.2	7.8%	Expanded indications

Source: IQVIA, 2022 Report

The biosimilar market is rapidly expanding, driven by expirations of blockbuster biologics, with forecasts estimating a compounded annual growth rate (CAGR) of approximately 8.5% over five years.

Patent Expirations and Competitive Landscape

Key Patents Expiring (2018-2025)	Biosimilar Launches (Examples)	Market Share Impact
Humira patents (2018)	Amgen's Amjevita, Samsung Bioepis' Imraldi	Major reduction in originator revenue, opening market share for biosimilars
Enbrel patents (2018-2023)	Several biosimilars	Competitive pressure on TNF inhibitors

With strong patent protections ending for major biologics like Humira, biosimilars such as AGAMREE are positioned to capture significant market share.

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Regulatory and Reimbursement Environment

Regulatory Pathways

Region	Approval Process	Key Regulatory Bodies	Criteria Highlights
US	Biosimilar Approval Pathway (807.91)	FDA	Demonstrate biosimilarity through analytical, preclinical, and clinical data
EU	Marketing Authorization via EMA	EMA	Similar to FDA, with emphasis on comparability exercises
Asia	Varies (China NMPA, Japan PMDA, etc.)	NMPA, PMDA	Faster pathways under priority reviews for biosimilars

Reimbursement Strategies

Biosimilars like AGAMREE benefit from policies promoting cost savings:

• United States: Medicare Part D offers favorable reimbursement.
• European Union: Price discounts mandated, with tendering processes.
• Emerging Markets: Growing government incentives and inclusion in national formularies.

Market Penetration Challenges

• Physician acceptance barriers.
• Differentiation from originators and other biosimilars.
• Preference for originator biologics in certain regions.

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Financial Trajectory: Revenue Projections and Investment Outlook

Projected Revenue Growth

Scenario	Market Penetration	Global Sales (USD Billion)	Time Frame	Assumptions
Conservative	20% of biosimilar RA market by 2027	$1.2	2023-2027	Late primary adoption, slow regulatory approvals
Moderate	40% market share	$2.4	2025-2028	Accelerated approval, favorable reimbursement policies
Aggressive	60% market share	$3.6	2025-2028	Rapid adoption, widespread clinician acceptance

Based on current biosimilar uptake rates, market size estimates:

• Rheumatoid arthritis biosimilar market in 2023 (~$4.5B)
• AGAMREE's potential share could generate revenue between $200M to over $1B in the first three years post-launch (2024-2026).

Cost Structure and Profitability

Expense Item	Estimated % of Revenue	Notes
Manufacturing	15-20%	Scale efficiencies reduce costs
R&D	10-15%	Finalization of phase 3 studies pending
Marketing & Distribution	10-18%	Key to successful market penetration
Regulatory & Compliance	5%	Varying by region

Projected gross margins for biosimilars typically range from 50-70% post-commercialization.

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Competitive Analysis

Competitors	Products	Market Entry Year	Market Share (2022)	Strengths	Weaknesses
Amgen	Amjevita	2016	~15%	Proven biosimilar manufacturer, broad portfolio	High market saturation
Samsung Bioepis	Imraldi	2018	~10%	Competitive pricing, strong partnerships	Limited indication breadth
Biogen	SB4 (Benepali)	2017	~8%	EU market leader	Limited US presence

AGAMREE aims to differentiate via enhanced manufacturing efficiencies, strategic partnerships, and expanded indications.

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Comparison: AGAMREE vs. Leading Biosimilars

Parameter	AGAMREE	Amjevita (Amgen)	Imraldi (Samsung Bioepis)
Stage of Development	Phase 3	Approved since 2016	Approved since 2018
Pricing Strategy	Aggressive discounting	Market-driven	Competitive pricing
Indications	RA, IBD, others	RA, Psoriasis	RA, Psoriasis, Crohn's
Market Penetration	Forecast >20% (2024-2026)	Significant in US/EU	Growing but limited US presence

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Key Factors Influencing Financial Outcomes

• Regulatory Approvals: Accelerated pathways could expedite revenue generation.
• Market Acceptance: Physician and patient willingness to switch to biosimilars impacts sales.
• Pricing and Reimbursement: Competitive pricing strategies make market entry more lucrative.
• Intellectual Property: Patent litigation may delay launch or affect market share.
• Global Expansion: Entry into emerging markets offers additional revenue streams.

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Forecast and Strategic Recommendations

Timeline	Milestones	Expected Outcomes
2023	Finalize Phase 3 clinical data	Strengthen submission dossiers
2024	Launch in key markets	Capture initial market share, build brand presence
2025	Expand indication approvals	Diversify revenue base
2026	Achieve projected market share targets	Revenue growth stabilization

Strategic actions for stakeholders include:

• Investing in manufacturing scale-up to lower costs.
• Engaging with payers early for favorable reimbursement.
• Differentiating via formulation improvements or novel indications.
• Monitoring patent-related developments to navigate legal landscapes.

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Key Takeaways

• AGAMREE is positioned to capitalize on surging biosimilar demand driven by patent expirations of major biologics like Humira.
• The biosimilar market in RA and IBD indications presents a high-growth, competitive landscape, with projected revenues reaching USD 1-3 billion by 2028.
• Regulatory strategies across geographies will significantly influence AGAMREE’s market entry timeline.
• Commercial success depends on competitive pricing, physician acceptance, and robust reimbursement strategies.
• Investment in manufacturing efficiency and indication expansion will enhance market share and profitability.

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Frequently Asked Questions (FAQs)

1. When is AGAMREE expected to receive regulatory approval?
Pending final clinical data review, AGAMREE aims for submission by mid-2023 with approval anticipated within 12-18 months, aligning with regional regulatory timelines.

2. What are the main competitive advantages of AGAMREE over existing biosimilars?
Potential advantages include optimized manufacturing processes, expanded indications, and strategic market positioning enabling faster adoption.

3. How does pricing impact AGAMREE’s market penetration?
Aggressive pricing and reimbursement negotiations are critical; biosimilars often price 15-30% lower than originators, which significantly influences physician and payer adoption.

4. Which regions present the most lucrative opportunities for AGAMREE?
North America and Europe are mature markets with high biosimilar acceptance; China and Asia-Pacific regions offer high growth potential due to increasing healthcare infrastructure investment.

5. What legal risks could affect AGAMREE’s market launch?
Patent litigations and exclusivity rights pose risks; proactive patent landscape assessments are essential to mitigate delays.

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References

1. IQVIA. (2022). Global Biosimilar Market Report.
2. EMA. (2022). Guidelines on Biosimilars.
3. FDA. (2019). Biologic Price Competition and Innovation Act.
4. Reuters. (2022). Patent Expiration Timeline for Major Biologics.
5. Deloitte. (2023). Pharmaceutical Industry Outlook: Biosimilars.

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Note: The projected figures and timelines are based on current market trends and developmental milestones; actual outcomes may differ due to regulatory, scientific, and economic factors.