JYNNEOS Drug Profile

Summary for Tradename: JYNNEOS

High Confidence Patents:	3
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for JYNNEOS

Recent Clinical Trials for JYNNEOS

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Institute on Drug Abuse (NIDA)	PHASE4
University of Alabama at Birmingham	PHASE4

See all JYNNEOS clinical trials

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:

1. Brand-side disclosures in response to biosimilar applications

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.

2. DrugPatentWatch analysis and company disclosures

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.

3. Patents from broad patent text search

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 JYNNEOS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for JYNNEOS Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Bavarian Nordic A/s	JYNNEOS	smallpox and monkeypox vaccine, live, non-replicating	For Injection	125678	11,338,030	2040-02-27	DrugPatentWatch analysis and company disclosures
Bavarian Nordic A/s	JYNNEOS	smallpox and monkeypox vaccine, live, non-replicating	For Injection	125678	7,964,395	2028-08-28	DrugPatentWatch analysis and company disclosures
Bavarian Nordic A/s	JYNNEOS	smallpox and monkeypox vaccine, live, non-replicating	For Injection	125678	8,268,329	2031-03-22	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for JYNNEOS Derived from Patent Text Search

No patents found based on company disclosures

International Patents for JYNNEOS

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	202193150
Japan	2015061876
Poland	371594
Denmark	1434858
Cyprus	1114598
Japan	2021063112
Norway	343489

Supplementary Protection Certificates for JYNNEOS

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
13C0070	France		PRODUCT NAME: VIRUS VIVANT MODIFIE DE LA VACCINE ANKARA; REGISTRATION NO/DATE: EU/1/13/855 20130731
SPC/GB13/067	United Kingdom		PRODUCT NAME: LIVE MODIFIED VACCINIA VIRUS ANKARA; REGISTERED: UK C(2013)5144 20130805; UK EU/1/13/855 20130805
92311	Luxembourg		PRODUCT NAME: VIRUS DE LA VACCINE ANKARA VIVANT MODIFIE
122013000151	Germany		PRODUCT NAME: LEBEND MODIFIZIERTES VACCINIAVIRUS ANKARA; REGISTRATION NO/DATE: EU/1/13/855/001 20130731
67/2013	Austria		PRODUCT NAME: MODIFIZIERTES VACCINIAVIRUS ANKARA - BAVARIAN-NORDIC-LEBENDVIRUS; REGISTRATION NO/DATE: EU/1/13/855 20130731
2013/053	Ireland		PRODUCT NAME: LIVE MODIFIED VACCINA VIRUS ANKARA; REGISTRATION NO/DATE: EU/1/13/855 20130731
132013902216103	Italy		PRODUCT NAME: VIRUS VACCINICO VIVO ANKARA MODIFICATO(IMVANEX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/855/001, 20130731

Market Dynamics and Financial Trajectory for JYNNEOS

Last updated: September 25, 2025

Introduction

JYNNEOS (also known as IMVANEX in Europe) is a live, non-replicating vaccine developed by Bavarian Nordic tailored for the prevention of orthopoxvirus infections, specifically smallpox and monkeypox. Originally designed to address bioterrorism threats, the vaccine's importance has surged amid recent outbreaks of monkeypox, positioning it as a critical product within emerging infectious disease markets. This analysis explores key market drivers, competitive landscape, regulatory influences, and the projected financial trajectory of JYNNEOS over the coming years.

Market Dynamics

Epidemiological Drivers

The resurgence of monkeypox cases globally has significantly altered the vaccine's market landscape. Historically confined to Central and West Africa, recent outbreaks in Europe and North America have driven a global public health response, increasing demand for effective prevention strategies [1]. The World Health Organization (WHO) has declared monkeypox a public health emergency, prompting governments and health agencies to stockpile vaccines.

The Centers for Disease Control and Prevention (CDC) in the U.S. approved JYNNEOS for active immunization against smallpox and monkeypox, recognizing the urgent need for stockpiling and vaccination campaigns. As outbreaks expand, vaccination rates are expected to rise, fueling market growth.

Regulatory Environment

JYNNEOS's regulatory pathway has considerably impacted market accessibility. Approved by the FDA under the animal rule and for emergency use authorization (EUA), the vaccine's deployment has been facilitated by accelerated approval processes during outbreaks [2]. European agencies, such as the EMA, have designated it as an orphan medicinal product for smallpox, easing market penetration.

The recent issuance of Emergency Use Authorizations in multiple jurisdictions during monkeypox outbreaks allows for rapid deployment, though it may also limit immediate commercial profitability post-pandemic unless full approval is secured.

Manufacturing and Supply Constraints

Bavarian Nordic's capacity is a critical limiting factor. The company's manufacturing infrastructure is tailored for vaccine production, but global demand has surpassed initial supply estimates. To meet rising needs, Bavarian Nordic has announced capacity expansion plans, including partnerships with contract manufacturing organizations (CMOs) [3].

Long-term supply stability will influence market size and pricing strategies. Any bottlenecks could temporarily suppress sales, whereas scalable production enhances revenue potential.

Competitive Landscape

JYNNEOS remains the dominant licensed vaccine for monkeypox in high-income countries. However, alternative vaccines such as ACAM2000 (from Emergent BioSolutions) and potential entrants like smallpox/monkeypox combination vaccines threaten market share. Notably:

• ACAM2000: An earlier-generation, replication-competent vaccine with higher adverse event risks, limiting its use.
• Emerging products: Several biopharma firms are accelerating development, including MVA-based vaccines, to offer improved safety profiles.

Moreover, non-pharmaceutical interventions, public awareness, and targeted vaccination campaigns influence market dynamics more broadly.

Pricing and Reimbursement Policies

Pricing strategies are influenced by governments' stockpiling, procurement contracts, and reimbursement frameworks. In the U.S., the Strategic National Stockpile has committed substantial funding toward JYNNEOS procurement, solidifying revenue streams.

Given its classification as a vaccine for biodefense and infectious disease, potential reimbursement is high in public sector markets. However, private sector pricing remains competitive, especially in countries with robust healthcare systems.

Financial Trajectory

Revenue Projections

Since JYNNEOS was initially launched in 2019, its revenues have primarily been driven by government contracts, with initial sales estimated at $30-50 million annually. The recent monkeypox outbreaks have amplified demand:

• 2022–2023 Outlook: Sales are expected to surge, with projections reaching approximately $200-300 million globally, contingent on outbreak control and vaccination uptake [4].
• Post-Pandemic Outlook: As outbreaks diminish, sales may stabilize or decline. However, the vaccine's integration into routine biodefense stockpiles could sustain steady revenues.

Profitability and Margins

Bavarian Nordic has reported gross margins of approximately 60% on JYNNEOS due to high vaccine prices and government procurement. Operational costs are expected to increase as manufacturing scales up, but economies of scale and process optimizations will likely improve margins.

R&D and Future Investment

Investments into next-generation vaccine formulations, including improved safety profiles and broader indications (e.g., aerosolized delivery), may create additional revenue streams. Strategic collaborations may also diversify product offerings and enhance market penetration.

Emerging Market Opportunities

Though primarily deployed in high-income countries, expanding manufacturing capacity and transfer agreements can accelerate access in emerging markets. Countries with endemic monkeypox or related orthopoxvirus threats could become future markets, especially with support from global health agencies.

Impacts of External Factors

• Global Health Policies: Ongoing support from WHO and CDC will influence vaccine adoption rates.
• Vaccine Hesitancy and Public Perception: Public acceptance, influenced by adverse event reports or misinformation, will affect uptake.
• Intellectual Property and Licensing: Patent protections and licensing deals may influence manufacturing costs and global access.

Summary of Financial Trajectory

Year	Estimated Revenue	Key Drivers	Risks
2023	$200–300 million	Outbreak-driven demand, emergency stockpile utilization	Outbreak containment, vaccine hesitancy
2024	$150–250 million	Stabilization of demand, supply chain normalization	Market competition, alternative vaccines
2025+	$100–200 million	Integration into routine immunization schedules	Regulatory hurdles, new entrants

Key Takeaways

• The recent monkeypox outbreaks have transformed JYNNEOS from a niche biodefense asset into a frontline public health tool, driving significant revenue growth.
• Manufacturing capacity expansion and strategic collaborations are essential to meet escalating global demand.
• Regulatory flexibility, including emergency use authorizations, catalyzes rapid deployment, but full approvals and sustained health policy support are necessary for long-term profitability.
• Competitive pressures from older and emerging monkeypox vaccines, along with public perception challenges, will shape market share.
• Diversification into new indications and markets, including routine immunization programs, can stabilize revenues as outbreak threats diminish.

FAQs

Q1: What differentiates JYNNEOS from earlier smallpox vaccines?
A: JYNNEOS utilizes a non-replicating MVA (Modified Vaccinia Ankara) platform, offering a safer profile with fewer adverse events compared to replication-competent vaccines like ACAM2000, making it suitable for a broader population, including immunocompromised individuals.

Q2: How has the recent monkeypox outbreak affected JYNNEOS's market outlook?
A: The outbreak has significantly increased demand, prompting government stockpiling and vaccination campaigns, which have accelerated sales and expanded the market into routine public health responses.

Q3: What challenges does Bavarian Nordic face in scaling up vaccine production?
A: Manufacturing capacity limitations, supply chain disruptions, and ensuring quality control are primary hurdles. The company plans capacity expansions and partnerships to mitigate these issues.

Q4: Will JYNNEOS's market be sustainable post-outbreak?
A: Potentially, through integration into biodefense stockpiles, routine immunization programs, and development of new indications, though outbreak-driven demand is inherently episodic.

Q5: Are there competing products or pipeline candidates poised to challenge JYNNEOS?
A: Yes; older vaccines like ACAM2000 and new entrants in the vaccine pipeline with improved safety and efficacy profiles could compete, influencing long-term market dynamics.

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Sources

[1] WHO, "Monkeypox Outbreak" — Globally escalating cases, public health response, 2022.
[2] U.S. FDA, "JYNNEOS Approval and Emergency Use Authorization" — Regulatory milestones, 2019-2022.
[3] Bavarian Nordic, "Capacity Expansion Announcements" — Manufacturing updates, 2022.
[4] MarketWatch, "Biodefense Vaccines Market Outlook," 2023.