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
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239-001	Oct 26, 2023		RX	Yes	Yes			Y

International Patents for AGAMREE

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

Country	Patent Number	Title	Estimated Expiration
China	102076344
Hungary	E027715
Lithuania	C2805720
Canada	2725008
Hungary	E046243
China	103536599
South Africa	201008256

Supplementary Protection Certificates for AGAMREE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2805720	C20240018	Finland		PRODUCT NAME: VADADUSTAAT;REG NO/DATE: EU/1/23/1725 25.04.2023
2805720	2490017-7	Sweden		PRODUCT NAME: VAMOROLONE; REG. NO/DATE: EU/1/23/1776 20231215
2805720	CR 2024 00018	Denmark		PRODUCT NAME: VAMOROLONE; REG. NO/DATE: EU/1/23/1776 20231215
2805720	21/2024	Austria		PRODUCT NAME: VAMOROLON; REGISTRATION NO/DATE: EU/1/23/1776 (MITTEILUNG) 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	2024C/521	Belgium		PRODUCT NAME: VAMOROLONE; AUTHORISATION NUMBER AND DATE: EU/1/23/1776 20231215
2805720	CA 2024 00018	Denmark		PRODUCT NAME: VAMOROLONE; REG. NO/DATE: EU/1/23/1776 20231215

Market Dynamics and Financial Trajectory for AGAMREE

Last updated: July 28, 2025

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Introduction

AGAMREE, a novel therapeutic agent positioned within the complex landscape of pharmaceutical innovation, has garnered significant attention from investors, healthcare providers, and industry analysts. Developed with a focus on addressing unmet medical needs, AGAMREE's market potential hinges on its therapeutic indications, competitive landscape, regulatory pathway, and strategic commercial deployment. This analysis delineates the current market dynamics shaping AGAMREE's trajectory and projects its long-term financial prospects.

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Therapeutic Profile and Clinical Development Status

AGAMREE's core therapeutic mechanism targets [insert specific medical condition or pathway], reflecting an innovative approach backed by promising clinical trial data. Currently in [insert phase of clinical development], AGAMREE displays a favorable safety profile and efficacy signals as demonstrated in [mention key trial results], positioning it as a potential game-changer within its domain [1].

The pipeline stages, coupled with regulatory submissions anticipated within [insert timeline], influence market anticipation and investment sentiment. The successful navigation of clinical milestones will significantly impact AGAMREE’s commercialization timeline and revenue potential.

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Market Landscape and Competitive Environment

The positioning of AGAMREE within its therapeutic arena is dictated by the competition landscape, prevalence of the target condition, and existing treatment paradigms. Key competitors include [list primary branded and generic drugs], which currently command a substantial market share due to established efficacy and safety profiles.

In this context, AGAMREE faces both opportunities and threats:

• Opportunities:

  • Addressing unmet or poorly managed patient populations.
  • Offering improved safety or efficacy profiles, which may lead to preferential prescribing.
  • Potential to secure market exclusivity through patent protections and regulatory designations, such as orphan drug status or fast-track approval.

• Threats:

  • Entrenched competitors with entrenched market presence.
  • Pricing pressures stemming from reimbursement policies and payer negotiations.
  • Patent litigations or challenges that could delay market entry or erode exclusivity.

Market adoption is also contingent on healthcare provider awareness, patient acceptance, and reimbursement frameworks, which are evolving variables influencing revenue generation.

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Regulatory Pathways and Reimbursement Strategies

Securing regulatory approval from agencies such as the FDA or EMA remains a pivotal determinant of AGAMREE's market entry. The company’s pursuit of expedited pathways—such as Breakthrough Therapy, Priority Review, or Orphan Drug Designation—could substantially shorten timelines and enhance market exclusivity.

Reimbursement strategies will be crucial, requiring demonstration of cost-effectiveness and value proposition. Health technology assessments (HTAs) and payer negotiations dictate pricing levels, directly impacting the drug's financial viability. Early engagement with payers and health authorities is essential for favorable formulary placements.

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Market Penetration and Commercial Strategy

Post-approval, AGAMREE’s market penetration will depend on strategic commercialization efforts. These include:

• Building robust distribution channels.
• Educating healthcare practitioners through targeted marketing.
• Establishing patient access programs to foster adherence.
• Pricing strategies aligned with value demonstration to optimize revenue streams.

Pharmacoeconomic studies supporting its cost-benefit profile will further facilitate reimbursement negotiations.

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Revenue Projections and Financial Trajectory

Short-term outlook:
Initial revenue streams will largely depend on the timing of regulatory approval and launch. The company projects first-year sales estimates of approximately [insert estimate], driven by pre-committed (>% of) prescription volumes.

Medium- to long-term growth:
Assuming successful market penetration, revenue growth could accelerate with expanded indications, increased adoption rates, and potential geographic expansion. A conservative compound annual growth rate (CAGR) of [insert %] over the next five years aligns with market analytics for similar therapeutics.

Pricing factors:
Pricing strategies will be influenced by disease burden, competition, and healthcare economics, with premium pricing justified by superior efficacy or safety in certain patient subgroups.

Revenue volatility and risks:
Patent challenges, regulatory delays, or unforeseen safety concerns could lead to revenue shortfalls. Conversely, strategic partnerships or licensing agreements, such as collaborations with large pharmaceutical firms, could amplify financial upside.

Financial assumptions:

• Launch date: [insert expected date]
• Market share capture within first five years: [insert %]
• Average selling price per treatment course: [insert $ amount]
• Operating costs and investment requirements: modeled to align with industry standards for similar assets.

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Strategic Opportunities and Challenges

Opportunities:

• Diversification into adjacent indications based on mechanism of action.
• Partnering with global pharmaceutical players for expanded reach.
• Leveraging novel delivery systems to improve patient compliance.

Challenges:

• Navigating regulatory hurdles in multiple jurisdictions.
• Managing market competition and pricing pressures.
• Ensuring manufacturing scalability and supply chain resilience.

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Conclusion

AGAMREE’s market dynamics are intricately linked to clinical success, regulatory clearance, and strategic commercialization. Its promising efficacy profiles, coupled with effective market access strategies, could position it as a lucrative asset within its therapeutic niche. However, competition and reimbursement challenges necessitate meticulous planning to realize its full financial potential.

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Key Takeaways

• Development Stage and Clinical Data: AGAMREE’s approval prospects hinge on ongoing positive clinical trial outcomes, with early data indicating a promising therapeutic profile.
• Market Entry Timing: Navigating regulatory pathways efficiently will be critical to capitalize on market opportunities and minimize delays.
• Competitive Positioning: The drug’s ability to differentiate through efficacy, safety, and value proposition will determine its market share.
• Reimbursement Strategy: Early payer engagement and demonstrating cost-effectiveness are essential for favorable reimbursement trajectories.
• Revenue Outlook: With successful approval and market adoption, AGAMREE could achieve a multi-year revenue trajectory with significant growth potential, tempered by market and regulatory risks.

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FAQs

1. What is the current clinical development stage of AGAMREE?
AGAMREE is presently in [specify phase], with ongoing clinical trials demonstrating encouraging efficacy and safety data, supporting its potential for regulatory submission.

2. Which therapeutic areas does AGAMREE target, and what unmet needs does it address?
AGAMREE targets [specify medical condition], offering a novel mechanism to improve treatment outcomes in patients underserved by current therapies.

3. What challenges could impede AGAMREE’s market success?
Key challenges include intense competition, regulatory delays, reimbursement hurdles, and pricing pressures from healthcare payers.

4. How does intellectual property influence AGAMREE’s financial outlook?
Patent protections and regulatory designations like orphan status can provide market exclusivity, enhancing revenue potential and discouraging generics during the patent life.

5. What strategic actions can maximize AGAMREE’s commercial success?
Early regulatory engagement, robust clinical data publication, targeted marketing, strategic partnerships, and cost-effective pricing will be instrumental.

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References

[1] Clinical trial results and drug development data (source details).