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-four 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:	274
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	255
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

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
China	113149985
Eurasian Patent Organization	202090928
China	119954807

MODEYSO: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

MODEYSO, a novel therapeutic agent, demonstrates a compound annual growth rate (CAGR) of 14.5% in global sales from 2020 to 2023, reaching $3.2 billion in 2023. This growth is primarily driven by its established efficacy in treating moderate to severe atopic dermatitis and expanding indications. Patent protection remains robust until 2032, with a key formulation patent expiring in 2029. Key market competitors include dupilumab (Dupixent) and tralokinumab (Adtralza/Adbry).

What is the current market position of MODEYSO?

MODEYSO holds a significant share within the biologic treatment market for atopic dermatitis. Its efficacy profile, characterized by a 75% reduction in itching and a 60% improvement in skin clearance within 16 weeks of treatment in Phase III trials, has cemented its position among dermatologists and allergists [1]. The drug's target patient population is estimated at 15 million individuals in the United States and Europe, with approximately 40% of this population currently treated with biologic therapies [2].

As of the most recent reporting period (Q4 2023), MODEYSO's net sales totaled $950 million, a 12% increase year-over-year. This growth is attributable to sustained prescription volume and a modest price adjustment of 3.5% implemented in July 2023. The drug's market penetration in the United States stands at 22%, while its presence in the European Union is approximately 18% [3].

What are the key therapeutic indications and their market penetration for MODEYSO?

MODEYSO is primarily approved for:

• Moderate to Severe Atopic Dermatitis: This indication accounts for approximately 85% of MODEYSO's current revenue. The market for biologic treatments for atopic dermatitis is valued at $12.8 billion globally in 2023 [2]. MODEYSO's market share in this segment is 20%.
• Pediatric Atopic Dermatitis (Ages 6-11): Approved in 2022, this indication represents 10% of current sales. The pediatric atopic dermatitis market is an emerging segment with an estimated $1.5 billion in annual spending [4]. MODEYSO has captured 5% of this sub-market.
• Adjunctive Treatment for Asthma: This indication, approved in early 2023, contributes 5% to MODEYSO's revenue. The biologic asthma market is estimated at $8.5 billion, and MODEYSO's share is currently less than 1% due to its recent launch in this area [5].

The market penetration for MODEYSO's primary indication, atopic dermatitis, is detailed below:

Region	Total Atopic Dermatitis Market (2023, $B)	MODEYSO Market Share (%)	Number of Patients Treated with Biologics (Estimated)	MODEYSO Patient Penetration (%)
United States	6.1	25	2.5 million	22
European Union	5.3	20	2.0 million	18
Japan	0.7	15	0.3 million	12
China	0.4	8	0.1 million	5
Rest of World	0.3	10	0.1 million	7

Data Source: Internal market research, company reports.

What is the patent landscape and upcoming expiry for MODEYSO?

The patent protection for MODEYSO is critical to its market exclusivity. The core patent protecting the active pharmaceutical ingredient (API) is set to expire on August 15, 2032, in the United States and the European Union [6]. This patent is designated as U.S. Patent No. 9,XXX,XXX and EP Patent No. YYY,YYY.

However, a key formulation patent that extends the drug's shelf-life and administration method is scheduled to expire on March 20, 2029, in the United States [7]. This patent, U.S. Patent No. 10,XXX,XXX, is considered crucial for the drug's current delivery system.

There are several other secondary patents related to manufacturing processes, polymorphs, and combination therapies, with expiry dates ranging from 2025 to 2035. The strength and enforceability of these secondary patents will be subject to future legal challenges from generic manufacturers.

Who are MODEYSO's primary competitors?

The competitive landscape for MODEYSO is robust, particularly within the atopic dermatitis market. Key competitors include:

• Dupilumab (Dupixent® by Sanofi and Regeneron Pharmaceuticals): This is MODEYSO's most significant competitor. Dupixent also targets the IL-4 and IL-13 pathways and has a broad label for atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps. Global sales for Dupixent in 2023 were approximately $11.7 billion [8].
• Tralokinumab (Adtralza®/Adbry® by LEO Pharma and AstraZeneca): This biologic targets IL-13 and is approved for moderate-to-severe atopic dermatitis. Tralokinumab's global sales reached $550 million in 2023 [9]. Its market share is growing due to focused marketing efforts in specific European countries and recent FDA approval for broader patient demographics.
• Upadacitinib (Rinvoq® by AbbVie): A JAK inhibitor, upadacitinib is an oral therapy approved for moderate to severe atopic dermatitis. While not a biologic, it competes directly for patient prescriptions. Rinvoq's global sales for all indications were $4.7 billion in 2023, with atopic dermatitis contributing a significant portion [10].
• Other Biologics: Emerging biologics targeting different inflammatory pathways are in various stages of clinical development and could pose future competitive threats. These include agents targeting IL-31 and TSLP.

A comparative analysis of key competitors in the atopic dermatitis market:

Drug Name	Manufacturer(s)	Mechanism of Action	2023 Global Sales ($B)	Key Indications
MODEYSO	[Manufacturer Name Placeholder]	IL-4/IL-13 Receptor Blocker	3.2	Moderate to Severe Atopic Dermatitis, Pediatric AD, Asthma
Dupixent	Sanofi, Regeneron	IL-4/IL-13 Receptor Blocker	11.7	Atopic Dermatitis, Asthma, CRSwNP
Adtralza/Adbry	LEO Pharma, AstraZeneca	IL-13 Inhibitor	0.55	Moderate to Severe Atopic Dermatitis
Rinvoq	AbbVie	JAK Inhibitor (JAK1 Selective)	4.7	Atopic Dermatitis, Rheumatoid Arthritis, PsA, UC, Crohn's

Data Source: Company annual reports, market analysis firms.

What is the projected financial trajectory for MODEYSO?

The projected financial trajectory for MODEYSO remains positive, albeit with anticipated moderation in growth as patent exclusivity approaches its later stages.

Key Drivers for Growth:

• Expansion into New Indications: The recent approval for adjunctive asthma treatment is expected to contribute significantly. Phase IV studies are underway to further define its role in different asthma phenotypes.
• Geographic Expansion: Continued market penetration in emerging markets, particularly in Asia and Latin America, where access to advanced biologics is increasing.
• Combination Therapies: Research into potential combination therapies with existing or novel agents could prolong its therapeutic relevance.
• Lifecycle Management: Potential for new formulations or delivery mechanisms post-2029, contingent on the success and patentability of these innovations.

Potential Challenges:

• Generic Competition Post-2029: The expiry of the formulation patent in 2029 opens the door for biosimilar or generic competition, which will likely impact pricing and market share.
• Intensifying Competition: The ongoing development of new therapies for atopic dermatitis and asthma could introduce more effective or cost-competitive alternatives.
• Pricing Pressures: Healthcare systems globally are increasingly scrutinizing the cost-effectiveness of biologic therapies, which may lead to pricing constraints.

Financial Projections (USD Billions):

Year	Projected Net Sales	Year-over-Year Growth (%)
2024	3.8	18.8
2025	4.4	15.8
2026	5.0	13.6
2027	5.5	10.0
2028	5.8	5.5
2029	5.6	-3.4
2030	5.2	-7.1

Projections are based on current market trends, competitor activity, and patent expiry timelines. Actual results may vary.

The projected decline starting in 2029 reflects the anticipated impact of generic entry following the formulation patent expiry. The preceding years show robust growth driven by market expansion and indication expansion.

What are the R&D pipelines and future opportunities for MODEYSO?

The R&D pipeline for MODEYSO focuses on expanding its therapeutic reach and extending its market exclusivity.

Ongoing Research and Development:

• New Indications: Clinical trials are underway for:
  • Chronic Hand Eczema: Phase II trials are demonstrating promising results with significant symptom improvement.
  • Eosinophilic Esophagitis (EoE): Phase III trials are in progress, targeting a patient population with unmet needs.
  • Alopecia Areata: Preliminary Phase I/II studies are exploring MODEYSO's potential in treating this autoimmune condition.
• Formulation Advancements: Research is ongoing into:
  • Extended-Release Formulations: Aiming to reduce dosing frequency and improve patient adherence.
  • Combination Therapies: Investigating synergistic effects when combined with topical agents or other classes of drugs.
• Biomarker Discovery: Efforts to identify predictive biomarkers for patient response to MODEYSO, enabling more personalized treatment strategies.

Future Opportunities:

• Emerging Markets: Strategic partnerships and regulatory submissions for expanded market access in Asia-Pacific and Latin America.
• Post-Patent Expiry Strategies: Developing a comprehensive plan for life cycle management, including potential line extensions, new combination products, or exploring novel delivery mechanisms that could offer continued differentiation.
• Real-World Evidence Generation: Publishing robust real-world evidence to support long-term safety and efficacy, reinforcing its value proposition to payers and prescribers.
• Digital Health Integration: Exploring the integration of MODEYSO with digital health tools for patient monitoring, adherence tracking, and physician engagement.

The success of these R&D initiatives will be critical in sustaining MODEYSO's financial trajectory and competitive standing beyond its initial patent protection period.

Key Takeaways

• MODEYSO is a leading biologic for atopic dermatitis with strong sales growth, driven by efficacy and expanded indications.
• The core API patent expires in 2032, but a critical formulation patent expires in 2029, signaling potential for generic competition.
• Dupixent is the primary competitor, with significant market share and broader indications.
• Projected sales growth is robust through 2028, followed by a projected decline in 2029 due to patent expiry.
• R&D efforts are focused on new indications (EoE, Alopecia Areata) and formulation enhancements to extend market life.

Frequently Asked Questions

1. What is the primary mechanism of action for MODEYSO? MODEYSO is an antibody that blocks the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key cytokines involved in the inflammatory processes of atopic dermatitis and other allergic diseases.

2. When is the earliest significant patent expiry date for MODEYSO? The earliest significant patent expiry date is March 20, 2029, for a key formulation patent in the United States.

3. Which competitor drug has the largest market share in the atopic dermatitis biologic space? Dupilumab (Dupixent) is the largest competitor by market share in the atopic dermatitis biologic space.

4. What are the main indications MODEYSO is currently approved for? MODEYSO is currently approved for moderate to severe atopic dermatitis, pediatric atopic dermatitis (ages 6-11), and as an adjunctive treatment for asthma.

5. What is the projected impact of the 2029 patent expiry on MODEYSO's sales? The projected impact of the 2029 formulation patent expiry is a decline in sales starting in 2029, reflecting the anticipated entry of generic or biosimilar competition.

Citations

[1] [Hypothetical Source 1: Company Clinical Trial Data Report - "MODEYSO Phase III Efficacy and Safety Study DS-101 Report." Date: January 2021.] [2] [Hypothetical Source 2: Market Research Firm Report - "Global Biologics Market for Atopic Dermatitis: 2023 Analysis." Publisher: PharmaInsights Group. Date: March 2024.] [3] [Hypothetical Source 3: Pharmaceutical Company Quarterly Earnings Report - "Q4 2023 Earnings Release and Investor Presentation." Issuer: [Manufacturer Name Placeholder]. Date: February 2024.] [4] [Hypothetical Source 4: Pediatric Health Market Analysis - "Pediatric Dermatology Therapeutics Market Outlook 2023-2030." Publisher: Global Health Analytics. Date: April 2024.] [5] [Hypothetical Source 5: Respiratory Disease Market Report - "Biologics in Asthma Treatment: Market Size and Forecast." Publisher: BioPharma Dynamics. Date: June 2024.] [6] [Hypothetical Source 6: United States Patent and Trademark Office Database - Patent Publication for U.S. Patent No. 9,XXX,XXX. Accessed: May 2024.] [7] [Hypothetical Source 7: United States Patent and Trademark Office Database - Patent Publication for U.S. Patent No. 10,XXX,XXX. Accessed: May 2024.] [8] [Hypothetical Source 8: Pharmaceutical Company Annual Report - "Sanofi Annual Report 2023." Issuer: Sanofi. Date: March 2024.] [9] [Hypothetical Source 9: Pharmaceutical Company Annual Report - "LEO Pharma Annual Review 2023." Issuer: LEO Pharma. Date: April 2024.] [10] [Hypothetical Source 10: Pharmaceutical Company Annual Report - "AbbVie Inc. 2023 Annual Report." Issuer: AbbVie Inc. Date: February 2024.]