MRESVIA Drug Profile
Summary for Tradename: MRESVIA
| High Confidence Patents: | 0 |
| Applicants: | 1 |
| BLAs: | 1 |
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:
- Brand-side disclosures in response to biosimilar applications
- DrugPatentWatch analysis and company disclosures
- Patents from broad patent text search
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.
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.
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 MRESVIA Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for MRESVIA Derived from DrugPatentWatch Analysis and Company Disclosures
No patents found based on company disclosures
3) Low Certainty: US Patents for MRESVIA Derived from Patent Text Search
No patents found based on company disclosures
MRESVIA Market Dynamics, Financial Trajectory, Competition, and Patent Position
MRESVIA, Moderna’s respiratory syncytial virus (RSV) vaccine, entered the U.S. market in 2024 as the company’s second commercial product. Its initial opportunity is concentrated in older adults, but commercial performance depends on seasonal vaccination demand, CDC recommendations, payer coverage, provider adoption, and competition from GSK’s Arexvy and Pfizer’s Abrysvo. Moderna reported approximately $25 million in MRESVIA product sales for 2024, a modest launch contribution relative to the company’s COVID-19 franchise and overall revenue base (Moderna, 2025a).
The vaccine has regulatory exclusivity as a reference biologic, but MRESVIA does not have an Orange Book listing because biologics are governed primarily through the Purple Book and the Biologics Price Competition and Innovation Act (BPCIA). No conventional Paragraph IV generic pathway applies. The principal near-term risks are limited adult uptake, a narrow initial label, seasonal purchasing patterns, and the established commercial position of competing RSV vaccines.
What is MRESVIA and how does it work?
MRESVIA is an mRNA vaccine containing Moderna’s mRNA-1345, which encodes the stabilized prefusion F protein of RSV. The vaccine is designed to induce an immune response against RSV-A and RSV-B strains.
The FDA approved MRESVIA on May 31, 2024, for the prevention of lower respiratory tract disease caused by RSV in adults 60 years of age and older. The approval followed a Phase 3 study involving approximately 37,000 adults aged 60 and older across multiple countries (FDA, 2024a).
MRESVIA product profile
| Attribute | MRESVIA |
|---|---|
| Sponsor | Moderna, Inc. |
| Active technology | Messenger RNA |
| Candidate | mRNA-1345 |
| Target | RSV prefusion F protein |
| FDA approval | May 31, 2024 |
| Initial population | Adults aged 60 and older |
| Administration | Single intramuscular dose |
| Therapeutic category | Preventive vaccine |
| Biologic application | BLA 125774 |
| U.S. regulatory pathway | Section 351(a) biologics license application |
| Primary competitors | Arexvy, Abrysvo |
| U.S. launch year | 2024 |
What is the FDA and regulatory status of MRESVIA?
MRESVIA is FDA-approved for older adults, but its commercial label is narrower than a broad all-adults indication. The CDC’s June 2024 recommendations prioritized adults aged 75 and older and adults aged 60 to 74 who are at increased risk of severe RSV disease. The recommendation replaced the earlier broad framework that allowed vaccination for all adults aged 60 and older through shared clinical decision-making (CDC, 2024).
This change reduced the immediately addressable U.S. population compared with a universal 60-plus recommendation. The most commercially relevant subgroups include adults in long-term care, people with chronic cardiopulmonary disease, immunocompromised patients, and adults with other risk factors for severe RSV outcomes.
Moderna submitted a supplemental application seeking use in adults aged 18 to 59 who are at increased risk of RSV disease. As of the end of 2024, that expansion remained subject to FDA review. Approval in the 18-to-59 high-risk population would increase the addressable market, but uptake would still depend on CDC recommendations and payer policies (Moderna, 2024a).
How does MRESVIA compare with FDA-approved RSV vaccines?
| Product | Company | Platform | Initial U.S. approval | Primary adult market |
|---|---|---|---|---|
| MRESVIA | Moderna | mRNA | 2024 | Adults aged 60 and older |
| Arexvy | GSK | Recombinant protein with adjuvant | 2023 | Adults aged 60 and older |
| Abrysvo | Pfizer | Bivalent prefusion F protein | 2023 | Older adults and maternal immunization |
| Beyfortus | Sanofi/AstraZeneca | Monoclonal antibody | 2023 | Infants |
MRESVIA is the only mRNA-based RSV vaccine in the U.S. adult market. Arexvy benefited from a first-mover launch and GSK’s established vaccine infrastructure. Abrysvo has a broader commercial profile because it is used in older adults and for maternal immunization to protect infants. MRESVIA does not compete directly with Beyfortus in the same patient population, although both products affect broader RSV prevention budgets.
How large is the MRESVIA market?
The U.S. market is large in epidemiological terms but difficult to convert into recurring revenue. RSV vaccination is an annual or seasonal adult vaccine opportunity, and current recommendations target selected older adults rather than the entire senior population.
The Centers for Disease Control and Prevention estimates that RSV causes substantial hospitalization and mortality among older adults, particularly those with underlying health conditions. The value proposition is strongest in patients with chronic obstructive pulmonary disease, heart failure, chronic kidney disease, diabetes, and immune suppression (CDC, 2024).
Commercial demand is constrained by five factors:
- RSV vaccination is a new category with limited historical adherence.
- Consumers may not distinguish among competing vaccines.
- Providers face seasonal administration and inventory-management challenges.
- Payers and pharmacies control much of the adult vaccination channel.
- Recommendations focus on risk-based vaccination rather than universal coverage.
The most attractive channel is likely pharmacy-based administration, supplemented by physician offices, hospitals, long-term-care facilities, and public-health programs. MRESVIA’s single-dose format supports seasonal vaccination campaigns, but its mRNA manufacturing and storage requirements can create operational complexity compared with established protein-based vaccines.
What were MRESVIA’s sales and financial trajectory?
Moderna reported approximately $25 million in MRESVIA product sales in 2024, its first partial commercial year (Moderna, 2025a). The figure was immaterial relative to Moderna’s total 2024 revenue, which was approximately $3.2 billion. COVID-19 products remained the dominant source of revenue.
MRESVIA financial trajectory
| Period | Commercial status | Financial assessment |
|---|---|---|
| 2023 | Pre-commercial | No marketed product revenue |
| First half of 2024 | FDA approval and launch preparation | Regulatory and manufacturing investment |
| Second half of 2024 | U.S. commercial launch | Approximately $25 million in reported 2024 product sales |
| 2025 onward | First full seasonal cycle | Primary test of demand, share, pricing, and channel execution |
MRESVIA is strategically important because it provides Moderna with a non-COVID commercial product and a platform validation point for additional mRNA vaccines. Its direct revenue contribution remains small. The product would need materially higher sales to offset the decline in COVID vaccine revenue or change Moderna’s overall financial profile.
Moderna’s 2025 company guidance projected total product sales of approximately $1.5 billion to $2.5 billion, reflecting lower COVID demand and the contribution of newer products, including MRESVIA (Moderna, 2025b). The company has not publicly identified MRESVIA as a standalone revenue driver capable of carrying the guidance range. Its financial importance is better measured as part of the respiratory-vaccine portfolio.
What drives MRESVIA revenue?
MRESVIA revenue is driven by:
- CDC recommendations and label expansion;
- comparative efficacy and safety data;
- pharmacy and wholesaler stocking;
- payer reimbursement;
- vaccination timing before and during RSV season;
- pricing relative to Arexvy and Abrysvo;
- provider familiarity with mRNA vaccines;
- repeat vaccination recommendations;
- international regulatory approvals.
The initial launch was affected by timing. FDA approval arrived shortly before the 2024-2025 RSV vaccination season, leaving limited time for provider education, contracting, distribution, and consumer awareness.
What patents protect MRESVIA?
MRESVIA is protected by a combination of Moderna’s mRNA, lipid nanoparticle, formulation, manufacturing, and RSV antigen intellectual property. The public FDA approval record does not provide an Orange Book-style list of patents for MRESVIA.
The relevant patent categories are:
mRNA composition patents
These may cover modified nucleosides, untranslated regions, codon optimization, RNA sequence design, and methods for producing or stabilizing mRNA. Moderna has disclosed a broad platform patent estate covering mRNA medicines and delivery systems.
Lipid nanoparticle patents
LNP patents may cover ionizable lipids, helper lipids, cholesterol, PEG-lipids, particle composition, particle size, encapsulation, and methods of delivering mRNA. These rights can create manufacturing and freedom-to-operate barriers even when the vaccine antigen itself is not protected by a single dominant patent.
RSV antigen and formulation patents
MRESVIA-specific rights may cover the mRNA-1345 sequence, expression constructs, the prefusion RSV F antigen, formulations, dose levels, and stability characteristics.
Manufacturing patents and trade secrets
Manufacturing protection may cover in vitro transcription, purification, encapsulation, sterile filling, analytics, scale-up, and quality-control procedures. Trade secrets can be commercially important because regulatory approval requires consistency and comparability across production sites.
No single public source establishes a complete, definitive list of every patent that could affect MRESVIA manufacture, sale, or biosimilar competition. Moderna’s platform rights, third-party LNP licenses, and product-specific applications should be assessed together.
What is the Orange Book and Purple Book status of MRESVIA?
MRESVIA is not expected to have an Orange Book patent listing because the Orange Book is principally used for approved drug products regulated under the Federal Food, Drug, and Cosmetic Act. MRESVIA was approved as a biologic under the Public Health Service Act.
The relevant FDA resource is the Purple Book. The Purple Book identifies licensed biological products and reference products but does not operate as a direct equivalent to the Orange Book’s patent-certification system (FDA, 2024b).
MRESVIA’s reference-product exclusivity period under the BPCIA is generally 12 years from first licensure, subject to statutory rules governing the reference product and any regulatory determinations. On that framework, biosimilar approval would generally not be available before approximately 2036, based on the 2024 approval date. Patent rights could extend beyond that period, but regulatory exclusivity and patent term are separate legal protections.
When does MRESVIA lose exclusivity?
MRESVIA’s principal regulatory exclusivity timeline is:
| Event | Date or expected timing |
|---|---|
| FDA approval | May 31, 2024 |
| Four-year biosimilar submission restriction | Generally until 2028 |
| Twelve-year reference-product approval restriction | Generally until 2036 |
| Patent expirations | Patent-specific; may extend beyond regulatory exclusivity |
| Pediatric exclusivity | Not identified as an approved extension as of the end of 2024 |
A biosimilar applicant cannot generally submit an abbreviated application during the first four years after reference-product approval and cannot generally receive approval during the first 12 years. A later biosimilar applicant would still face patent litigation, manufacturing comparability requirements, interchangeability considerations, and commercial contracting barriers.
Are there Paragraph IV challenges to MRESVIA?
No conventional Paragraph IV challenge applies to MRESVIA. Paragraph IV certifications are associated with abbreviated new drug applications for small-molecule drugs under the Hatch-Waxman Act.
A biosimilar applicant challenging MRESVIA-related patents would use the BPCIA patent-exchange process, often called the patent dance, followed by potential federal litigation under 35 U.S.C. § 271(e)(2). The timing of any dispute would depend on when a biosimilar applicant submits an application, when Moderna receives notice, and which patents are asserted.
No publicly reported MRESVIA-specific BPCIA litigation or settlement agreement had been identified through the end of 2024. The absence of a reported challenge is consistent with the product’s recent launch and the long period before biosimilar approval becomes available.
How strong is the MRESVIA patent estate?
MRESVIA’s patent position is likely strongest at the platform and manufacturing levels rather than through a single product patent. Moderna’s advantages include:
- proprietary mRNA design and production capabilities;
- LNP formulation expertise;
- manufacturing scale and regulatory know-how;
- product-specific mRNA-1345 development rights;
- accumulated clinical and process data.
The main weaknesses are commercial and legal rather than purely technical. Broad platform patents may face validity, scope, enablement, or freedom-to-operate challenges. Third-party rights relating to nucleoside modification, LNP chemistry, or vaccine manufacturing could create licensing exposure. A biosimilar competitor might also seek a different formulation or delivery system to avoid selected claims.
The practical barrier to competition is therefore likely to be a combination of patents, manufacturing complexity, regulatory data requirements, and market access contracts.
What licensing deals affect MRESVIA?
Moderna developed MRESVIA internally and has not publicly disclosed a major co-commercialization or out-licensing transaction specifically for MRESVIA. Its broader mRNA platform has been subject to licensing arrangements, collaboration agreements, and patent disputes involving third parties. Those agreements can affect freedom to operate even when they do not identify MRESVIA by brand name.
The relevant diligence issues are:
- licenses to modified-nucleoside technology;
- LNP component rights;
- rights to RSV antigen constructs;
- territorial rights;
- royalty obligations;
- sublicensing restrictions;
- government-use or public-sector rights;
- manufacturing-site rights.
What litigation and settlement risks affect MRESVIA?
MRESVIA could face litigation in four areas:
- Patent disputes involving mRNA or LNP technology.
- Product-liability litigation related to vaccine safety.
- Commercial disputes involving supply, distribution, or government procurement.
- Regulatory litigation or challenges involving label expansion and manufacturing.
No major MRESVIA-specific patent settlement was publicly reported through the end of 2024. The product could still be affected by broader Moderna patent litigation because platform patents may cover multiple mRNA products.
What generic, biosimilar, and launch risks exist?
A conventional generic launch is not applicable. The relevant future entrant is a biosimilar or a biologic vaccine using a competing mRNA or protein-based technology.
Early-entry scenario
A biosimilar or follow-on product would likely be blocked by the 12-year reference-product exclusivity period until approximately 2036. Patent litigation could delay entry further.
At-risk launch scenario
An applicant could launch after regulatory approval but before all patent disputes are resolved, exposing itself to damages and injunctive-relief risk. This scenario is less likely while key platform and formulation patents remain enforceable.
Non-infringing competitor scenario
A rival could develop a different RSV antigen construct, delivery system, or manufacturing process. Arexvy and Abrysvo already demonstrate that competitive entry does not require biosimilar status.
The most immediate threat is not biosimilar entry. It is loss of market share to established RSV vaccines and weak repeat vaccination demand.
How does MRESVIA compare with Moderna’s other products?
| Metric | MRESVIA | Spikevax |
|---|---|---|
| Disease | RSV | COVID-19 |
| Platform | mRNA | mRNA |
| Launch | 2024 | 2020 |
| Market maturity | New category | Mature, declining market |
| Demand pattern | Seasonal | Seasonal and variant-driven |
| Main competitors | Arexvy, Abrysvo | Comirnaty, Nuvaxovid |
| Strategic role | Portfolio diversification | Core legacy revenue source |
| 2024 financial contribution | Approximately $25 million | Multi-billion-dollar product sales |
MRESVIA has higher growth potential than Spikevax because it is entering a newer market, but its base is much smaller and the category is more concentrated among older adults. The product cannot yet replace COVID revenue on a dollar-for-dollar basis.
Key Takeaways
- MRESVIA received FDA approval on May 31, 2024, for adults aged 60 and older.
- CDC guidance concentrates use on adults aged 75 and older and high-risk adults aged 60 to 74.
- Moderna reported approximately $25 million in MRESVIA product sales in 2024.
- The principal competitors are GSK’s Arexvy and Pfizer’s Abrysvo.
- MRESVIA is not an Orange Book drug and does not face conventional Paragraph IV challenges.
- BPCIA reference-product exclusivity generally limits biosimilar approval until approximately 2036.
- Moderna’s strongest barriers are its mRNA platform, LNP technology, manufacturing capabilities, and regulatory data.
- The near-term commercial risk is limited uptake, not biosimilar entry.
- A label expansion to high-risk adults aged 18 to 59 would materially improve market potential.
- MRESVIA is strategically important to Moderna’s non-COVID pipeline but remained a small contributor to company revenue through 2024.
FAQs About MRESVIA Market and Patent Outlook
Is MRESVIA covered by Medicare?
MRESVIA may be covered under Medicare Part D or other applicable vaccination coverage pathways, depending on the patient’s eligibility, administration setting, and current federal policy. Pharmacy and provider billing arrangements influence access.
Does MRESVIA require annual vaccination?
MRESVIA is administered as a single dose. Whether and when revaccination is recommended depends on future FDA labeling, CDC guidance, clinical data, and public-health policy.
Can MRESVIA be used in pregnant patients?
MRESVIA’s initial FDA approval was for older adults, not maternal immunization. Pfizer’s Abrysvo has a distinct maternal-immunization indication, creating a market differentiation that MRESVIA does not currently match.
What is the biggest commercial threat to MRESVIA?
The largest near-term threat is competition from Arexvy and Abrysvo combined with low RSV vaccine uptake among eligible adults. A narrow risk-based recommendation also limits the immediately addressable U.S. market.
Could Moderna license MRESVIA outside the United States?
Moderna could pursue regional partnerships or licensing arrangements, but no major MRESVIA-specific licensing transaction had been publicly disclosed through the end of 2024. International commercialization depends on country-specific approvals, reimbursement, and supply agreements.
References
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Centers for Disease Control and Prevention. (2024). RSV vaccination for older adults. https://www.cdc.gov/rsv/vaccines/older-adults.html
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Food and Drug Administration. (2024a, May 31). FDA approves first mRNA vaccine for respiratory syncytial virus (RSV). https://www.fda.gov
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Food and Drug Administration. (2024b). Purple Book: Database of licensed biological products. https://purplebooksearch.fda.gov
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Moderna, Inc. (2024a). Moderna announces FDA acceptance of supplemental biologics license application for mRESVIA in adults aged 18 to 59 at increased risk for RSV. https://www.modernatx.com
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Moderna, Inc. (2025a). 2024 annual report. U.S. Securities and Exchange Commission. https://www.sec.gov
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Moderna, Inc. (2025b). Moderna reports fourth quarter and full-year 2024 financial results and provides business updates. https://www.modernatx.com
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