ACAM2000 Drug Profile

Summary for Tradename: ACAM2000

High Confidence Patents:	643
Applicants:	1
BLAs:	1

Pharmacology for ACAM2000

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Live Vaccinia Virus Vaccine
Chemical Structure	Smallpox Vaccine Vaccines, Live, Unattenuated

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 ACAM2000 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ACAM2000 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
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2019-08-05	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2017-03-04	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2020-04-04	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2020-02-25	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2024-08-05	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2022-05-14	DrugPatentWatch analysis and company disclosures
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2024-05-17	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ACAM2000 Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2036-08-11	Patent claims search
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2036-08-11	Patent claims search
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2034-12-31	Patent claims search
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2038-06-27	Patent claims search
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2038-07-24	Patent claims search
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2031-05-02	Patent claims search
Emergent Product Development Gaithersburg, Inc.	ACAM2000	smallpox (vaccinia) vaccine, live	For Injection	125158		2034-01-27	Patent claims search

International Patents for ACAM2000

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	03027154
Germany	202012008255
Serbia	54065
European Patent Office	2705921
Canada	2421151
Japan	5602762
Japan	2004534374

Supplementary Protection Certificates for ACAM2000

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C300610	Netherlands		PRODUCT NAME: GEINACTIVEERD CHIMERISCH FLAVIVIRUS, STAM YF-WN; REGISTRATION NO/DATE: EU/2/13/151 20130606
CR 2022 00050	Denmark		PRODUCT NAME: TEZEPELUMAB; REG. NO/DATE: EU/1/22/1677 20220919
1390042-8	Sweden		PRODUCT NAME: INAKTIVERAT CHIMAERT FLAVIVIRUS, STAM YF-WN; REG. NO/DATE: EU/2/13/151 20130606
809	Finland
C300623	Netherlands		PRODUCT NAME: LEVEND GEMODIFICEERD VACCINA ANKARA - BAVARIA NORDIC VIRUS; REGISTRATION NO/DATE: EU/1/13/855 20130731
301207	Netherlands		PRODUCT NAME: TEZEPELUMAB; REGISTRATION NO/DATE: EU/1/22/1677 20220920
122022000079	Germany		PRODUCT NAME: TEZEPELUMAB; REGISTRATION NO/DATE: EU/1/22/1677 20220919

Market Dynamics and Financial Trajectory for the Biologic Drug: ACAM2000

Last updated: September 25, 2025

Introduction

ACAM2000, developed by Emergent BioSolutions (originally by Acambis), is a live attenuated vaccinia virus vaccine primarily designed for the prevention of smallpox. As a biological product, ACAM2000 plays a pivotal role in biodefense as the only U.S. Food and Drug Administration (FDA)-approved smallpox vaccine under the Strategic National Stockpile (SNS). The drug's market and financial outlook are shaped by evolving biothreat assessments, regulatory landscapes, and global health policies. This analysis delineates the market dynamics, competitive positioning, revenue trajectories, and emerging opportunities for ACAM2000 within this complex landscape.

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Market Landscape and Key Drivers

Biothreat Preparedness and Government Procurement

ACAM2000’s primary market stems from governmental agencies, chiefly the US Department of Health and Human Services (HHS), under the Department of Defense (DoD) and the CDC's biodefense program. Its approval as a biodefense countermeasure highlights a government-driven market, with stockpiling mandated under national security initiatives. The U.S. government historically allocates substantial budgets for biodefense preparedness, with $580 million dedicated to smallpox vaccine stockpiling in the fiscal year 2022 [1].

The COVID-19 pandemic emphasized the importance of robust vaccine stockpiles, spurring increased investments in biodefense vaccines, including ACAM2000. However, despite the pandemic's impact in reinforcing global biosecurity strategies, ACAM2000’s market remains predominantly within the U.S., limiting international penetration without additional regulatory approvals.

Regulatory Status and Market Exclusivity

ACAM2000 is FDA-approved under the Biologics License Application (BLA) pathway, with orphan designation granting it certain exclusivity rights until 2024, potentially extending through data exclusivity periods [2]. The vaccine’s safety profile, however, is more complex compared to newer vaccines like JYNNEOS (Imvamune), which has been approved for smallpox and monkeypox with an improved safety profile.

Given the advent of JYNNEOS, which boasts fewer adverse events and is approved for both smallpox and monkeypox, the market share of ACAM2000 faces potential erosion outside niche biodefense applications. Nonetheless, ACAM2000’s established stockpile position and emergency use authorizations (EUAs) sustain its relevance.

Emerging Opportunities: Monkeypox Outbreak

The recent resurgence of monkeypox in non-endemic countries has revitalized interest in smallpox vaccines, including ACAM2000. Although the FDA has authorized JYNNEOS for monkeypox, ACAM2000's role remains relevant due to its longstanding use and existing stockpiles. However, safety concerns, such as contraindications in immunocompromised populations and those with eczema, limit its widespread adoption for post-exposure prophylaxis (PEP).

This recent epidemiological shift offers opportunistic avenues for ACAM2000, especially in strategic military or high-risk civilian populations where rapid deployment and stockpile reliability are critical.

Competitive Landscape

ACAM2000 faces competition from JYNNEOS, marketed by Bavarian Nordic, which offers a safer profile. JYNNEOS's approval for both smallpox and monkeypox, alongside its preferable safety profile, positions it as the preferred vaccine for civilian use. Nonetheless, ACAM2000 remains the primary vaccine for the U.S. government's biodefense stockpile, conferring it a protected position within that niche.

Emergent competitors and technological advances in vaccine platforms could further challenge ACAM2000's market share in specific markets or indications.

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Financial Trajectory and Revenue Projections

Historical Revenue Trends

As a biodefense product, ACAM2000’s revenues largely derive from government contracts, notably from the HHS. Between 2018 and 2021, US government procurement accounted for approximately \$27 million annually, reflecting the vaccine’s steady, if modest, contribution to the company's top line [3]. Fluctuations correlate with biodefense budget allocations and stockpile replenishment cycles.

Impact of Regulatory and Policy Changes

Introduction of JYNNEOS and safety concerns with ACAM2000 exert downward pressure on future procurement volumes. Nonetheless, ACAM2000's role as a secondary biodefense asset and its established stockpile infrastructure offer downside protection absent significant policy shifts.

Projected Revenue Outlook

Looking forward, revenues are expected to plateau or decline unless new indications emerge or broader international procurement ensues. The recent monkeypox outbreak could temporarily increase procurement, especially if authorities rely on ACAM2000 for high-risk or military personnel, but the long-term financial impact remains uncertain.

Emerging biothreats or potential biothreat crises could, contrarily, stimulate increased investments, underpinning a potential rebound in revenue streams.

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Strategic Considerations and Future Outlook

Safety Profile and Market Acceptance

The safety concerns associated with ACAM2000, notably in immunocompromised individuals, significantly limit its civilian use. This restricts its commercial viability outside biodefense contexts. The FDA’s approval of JYNNEOS offers a safer alternative, further challenging ACAM2000’s broader market penetration [4].

Development of Next-Generation Vaccines

Future deployment depends on advances in vaccine technology, including improved safety profiles, thermostability, and broader indications such as monkeypox and other orthopoxvirus-related infections. ACAM2000’s manufacturing infrastructure could be repurposed or leveraged for new vaccine development to diversify revenue streams.

Government and International Policy Dynamics

The U.S. government remains committed to biodefense preparedness, with annual or multi-year procurement contracts that support a baseline revenue, positioning ACAM2000 as a strategic reserve. International markets for smallpox or related vaccines remain limited owing to regulatory barriers and lack of endemic disease, constraining revenue growth.

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Key Takeaways

• Market Positioning: ACAM2000 remains the cornerstone of U.S. smallpox biodefense stockpiles but faces increasing competition from newer vaccines with superior safety profiles, notably JYNNEOS.

• Revenue Dynamics: Government procurements are stable but modest, with revenues primarily constrained by vaccine safety perceptions and the emergence of alternative products.

• Growth Opportunities: The recent monkeypox outbreaks temporarily bolster demand, but long-term growth depends on expanding indications and international acceptance.

• Challenges: Safety concerns, regulatory competition, and limited global market access restrict market expansion, necessitating strategic diversification.

• Strategic Outlook: Cost-effective manufacturing, potential development of next-generation vaccines, and policy support remain crucial for maintaining relevance and financial viability.

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FAQs

1. What distinguishes ACAM2000 from newer smallpox vaccines?
   ACAM2000, a live vaccinia virus vaccine, has been associated with higher rates of adverse events, including myocarditis and myopericarditis, particularly in immunocompromised populations. JYNNEOS offers a non-replicating, safer alternative with a broader approval profile [4].

2. Can ACAM2000 be used for monkeypox prevention?
   While historically used for smallpox, ACAM2000 has limited safety in certain populations, and JYNNEOS is now primarily recommended for monkeypox due to its improved safety profile. However, ACAM2000 remains in stockpiles for biodefense readiness.

3. What are the key regulatory challenges facing ACAM2000?
   Safety concerns and competition from newer vaccines impact its prescribing and procurement. Additionally, regulatory approvals for additional indications are limited, restricting market expansion.

4. How reliant is ACAM2000 on government contracts?
   Primarily, yes. Its revenue depends on annual government procurement budgets, with minimal commercial sales outside biodefense and emergency preparedness.

5. Is there potential for ACAM2000 to generate significant revenue in the future?
   Unlikely, unless new indications emerge, manufacturing costs decrease dramatically, or international markets open up. The current focus remains on biodefense contingencies and strategic reserves.

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References

[1] US Department of Health and Human Services. (2022). Fiscal Year 2022 Budget Overview.
[2] FDA. (2018). ACAM2000 Biologics License Application.
[3] Emergent BioSolutions. (2021). Annual Report.
[4] CDC. (2022). Smallpox and Monkeypox Vaccines: Safety and Efficacy.