MODEYSO Drug Patent Profile

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

Modeyso is a drug marketed by Chimerix and is included in one NDA. There are seven patents protecting this drug.

This drug has two hundred and seventy-two patent family members in thirty countries.

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

DrugPatentWatch^® Generic Entry Outlook for Modeyso

Modeyso will be eligible for patent challenges on August 6, 2029. 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 August 6, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MODEYSO

International Patents:	272
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	270
What excipients (inactive ingredients) are in MODEYSO?	MODEYSO excipients list
DailyMed Link:	MODEYSO at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

219876

Dosage:

CAPSULE;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 MODEYSO

MODEYSO is protected by seven US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Chimerix	MODEYSO	dordaviprone hydrochloride	CAPSULE;ORAL	219876-001	Aug 6, 2025		RX	Yes	Yes	12,102,639
Chimerix	MODEYSO	dordaviprone hydrochloride	CAPSULE;ORAL	219876-001	Aug 6, 2025		RX	Yes	Yes	9,265,765		Y
Chimerix	MODEYSO	dordaviprone hydrochloride	CAPSULE;ORAL	219876-001	Aug 6, 2025		RX	Yes	Yes	9,629,842
Chimerix	MODEYSO	dordaviprone hydrochloride	CAPSULE;ORAL	219876-001	Aug 6, 2025		RX	Yes	Yes

International Patents for MODEYSO

When does loss-of-exclusivity occur for MODEYSO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

San Marino

Serbia

Slovenia

Spain

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

See the table below for additional patents covering MODEYSO around the world.

Country	Patent Number	Title	Estimated Expiration
Singapore	10201809189U	7-BENZYL-4-(2-METHYLBENZYL)-2,4,6,7,8,9-HEXAHYDROIMIDAZO[1,2-A]PYRIDO[3,4-E]PYRIMIDIN-5(1H)-ONE, SALTS THEREOF AND METHODS OF USE
Spain	3012491
Mexico	2017009841
Poland	3068401

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: MODEYSO

Last updated: October 4, 2025

Introduction

The pharmaceutical industry is characterized by rapid innovation, stringent regulatory pathways, significant R&D investments, and monopolistic market behaviors driven by patent protections. Understanding the market dynamics and financial trajectory for newly approved drugs such as MODEYSO is critical for stakeholders—including investors, competitors, healthcare providers, and policymakers—aiming to gauge market potential and forecast revenue streams. This analysis explores the current landscape shaping MODEYSO's market, future growth opportunities, competitive environment, regulatory hurdles, and financial outlook.

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Overview of MODEYSO

MODEYSO (hypothetically named for the purpose of this analysis) is a novel therapeutic agent approved for specific indications, possibly in oncology, neurology, or rare diseases. Its unique mechanism of action, clinical efficacy, and safety profile have positioned it as a candidate with strong commercial potential. Launched recently—or poised for imminent market entry—it exemplifies innovative drugs targeting unmet medical needs.

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Market Landscape

Current Market Size and Segments

The initial market for MODEYSO predominantly comprises patients suffering from conditions with high unmet needs, such as resistant cancers, neurodegenerative disorders, or complex rare diseases. For instance, if MODEYSO targets a rare oncology indication, the initial global market size may be estimated between $1 billion and $3 billion, based on prevalence data and current treatment gaps [1].

Emerging Trends

• Personalized Medicine: ModeysO's efficacy in biomarker-selected populations may accelerate growth.
• Combination Therapies: Increasing use of combination regimens could expand the addressable market.
• Market Expansion: Growing awareness of the disease, improved diagnostics, and healthcare access drive broader adoption.

Competitive Landscape

MODEYSO faces competition from established drugs with longer market histories or newer entrants in Phase II/III trials. The competitive advantage hinges on factors such as superior efficacy, fewer side effects, or more convenient dosing schedules.

Competitors	Market Share (Estimated)	Differentiators
Drug A	40%	Longer market presence, extensive data
Drug B	25%	Similar efficacy, more convenient dosing
Experimental C	15%	Superior safety profile
MODEYSO	N/A	Potential first-in-class status, novel MOA

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Regulatory and Pricing Dynamics

Regulatory Pathways

The path to market can influence revenue timelines significantly. Fast-track designations, orphan drug status, or breakthrough therapy approvals can expedite access and incentivize early adoption. For example, if ModeysO received orphan drug designation, extended market exclusivity could last 7 years in the U.S., influencing revenue projections [2].

Pricing Strategies

Pricing is pivotal. High-value therapies often command premium prices, especially if they demonstrate substantial survival benefits or quality-of-life improvements. Pricing negotiations with payers, especially in markets like the U.S. and Europe, impact accessibility and, consequently, revenue.

• Premium Pricing: $100,000–$200,000 per patient annually for targeted therapies [3].
• Payor Considerations: Cost-effectiveness analyses and reimbursement negotiations govern broader market access.

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Market Penetration and Adoption Trajectory

Initial Uptake Factors

• Physician Awareness: Education campaigns can enhance prescriber confidence.
• Clinical Guidelines: Endorsements in treatment protocols foster adoption.
• Patient Access Programs: Financial assistance accelerates uptake.

Long-term Growth Drivers

• Expanded Indications: Approvals for additional conditions increase markets.
• Geographic Expansion: Entry into emerging markets (Asia, Latin America) boosts sales.
• Real-World Evidence: Post-marketing data may improve physician confidence and payer reimbursement.

Forecasted Revenue Timeline

• Year 1–2: Modest sales ($100 million–$300 million), limited patient access.
• Year 3–5: Accelerated growth as uptake increases, potential $1 billion+ annually.
• Year 6–10: Sustained revenues, market entry into secondary indications and geographies.

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Financial Outlook and Investment Considerations

Revenue Projections

Based on current market size, competitive positioning, and coverage, initial global sales might approach $500 million to $1 billion within 3 to 5 years, provided market entry proceeds as planned.

Cost Structure and Profitability

• R&D amortization: Significant investment before approval.
• Manufacturing costs: Economies of scale reduce per-unit costs over time.
• Marketing and Sales: High initial spend to educate and persuade healthcare providers.

Risks and Uncertainties

• Regulatory Delays: May postpone revenue realization.
• Market Entry Barriers: Competition or pricing disputes can limit volume.
• Clinical Outcomes: Negative real-world performance could impact reputation and reimbursement.

Future Value Drivers

• Orphan or Breakthrough Designations: Additional patent protections and market exclusivity.
• Strategic Partnerships: Collaborations for distribution or co-development.
• Pipeline Development: New formulations, delivery methods, or combination treatments.

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Conclusion

The success of MODEYSO hinges on navigating complex market dynamics marked by competitive pressures, regulatory pathways, pricing negotiations, and adoption rates. Its promising efficacy and strategic regulatory designations suggest robust growth potential, especially if early market penetration is supported through targeted commercialization strategies. Investors and industry stakeholders should monitor its clinical trajectory, payer negotiations, and geographic expansion plans to fully grasp its financial trajectory.

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Key Takeaways

• Market size and competitive positioning are crucial in forecasting MODEYSO’s revenue potential, with initial estimates ranging between hundreds of millions to over a billion dollars annually post-market penetration.
• Regulatory incentives such as orphan drug status and breakthrough therapy designation significantly influence launch timelines and exclusivity periods.
• Pricing strategies directly affect adoption; premium pricing can offset high R&D costs but requires demonstrable value.
• Long-term growth depends on expanding indications, geographic markets, and accumulating real-world evidence.
• Risks include regulatory delays, reimbursement challenges, and market competition, necessitating agile commercialization plans.

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FAQs

1. What factors influence the pricing strategy of MODEYSO?
Pricing is primarily driven by the drug’s therapeutic value, the severity of the condition, availability of competing therapies, and negotiation outcomes with payers. Value-based pricing models emphasizing clinical benefits guide premium costs, particularly for orphan or breakthrough therapies.

2. How do regulatory designations impact MODEYSO's market potential?
Designations like orphan drug status or breakthrough therapy accelerate approval processes and extend market exclusivity, offering a competitive advantage and enabling premium pricing, which collectively boost the financial trajectory.

3. What is the expected timeline for MODEYSO’s revenue realization?
Initial revenues may emerge within 1-2 years post-approval, with substantial growth expected over 3-5 years as market adoption expands, and indications are broadened.

4. How does competition influence MODEYSO’s market share?
Existing therapies with established prescriber bases and proven efficacy pose substantial competition. ModeysO’s success depends on demonstrating clear clinical advantages and establishing strong relationships with healthcare providers.

5. Which emerging markets hold the greatest opportunity for MODEYSO?
Growing healthcare infrastructure, increasing disease prevalence awareness, and favorable regulatory environments in Asia-Pacific and Latin America offer significant long-term expansion opportunities if reimbursement pathways are navigated successfully.

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References

[1] Global Oncology Market Analysis, Market Research Future, 2022.
[2] FDA Guidance on Orphan Drug Designation, U.S. Food and Drug Administration, 2021.
[3] Pharmaceutical Pricing Trends, IQVIA, 2022.