TEMBEXA Drug Patent Profile

When do Tembexa patents expire, and when can generic versions of Tembexa launch?

Tembexa is a drug marketed by Emergent Biodefense and is included in two NDAs. There are five patents protecting this drug.

This drug has forty-seven patent family members in fifteen countries.

The generic ingredient in TEMBEXA is brincidofovir. Two suppliers are listed for this compound. Additional details are available on the brincidofovir profile page.

DrugPatentWatch^® Generic Entry Outlook for Tembexa

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 31, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TEMBEXA

International Patents:	47
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	537
What excipients (inactive ingredients) are in TEMBEXA?	TEMBEXA excipients list
DailyMed Link:	TEMBEXA at DailyMed

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

Constraining patent/regulatory exclusivity:

9,303,051

NDA:

214460

Dosage:

SUSPENSION;ORAL

Constraining patent/regulatory exclusivity:

8,962,829

NDA:

214461

Dosage:

TABLET;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 TEMBEXA

TEMBEXA is protected by five US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,303,051.

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
Emergent Biodefense	TEMBEXA	brincidofovir	SUSPENSION;ORAL	214460-001	Jun 4, 2021		RX	Yes	Yes	9,303,051		Y	Y
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes	9,371,344		Y
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes	9,303,051		Y	Y
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes
Emergent Biodefense	TEMBEXA	brincidofovir	SUSPENSION;ORAL	214460-001	Jun 4, 2021		RX	Yes	Yes
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes	10,112,909
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes	8,962,829		Y	Y

International Patents for TEMBEXA

When does loss-of-exclusivity occur for TEMBEXA?

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

Australia

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Russian Federation

South Korea

Spain

Ukraine

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 TEMBEXA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2016094388	ホスホン酸エステル誘導体およびその合成方法 (PHOSPHONATE ESTER DERIVATIVE AND METHOD OF SYNTHESIS THEREOF)
Japan	2013536865
Israel	238217	נגזרות אסטר פוספונטיות ושיטות של סינתזה שלהן (Phosphonate ester derivatives and methods of synthesis thereof)
China	111777639	十六烷氧基丙基膦酸酯的形态 (Morphic forms of hexadecyloxypropyl-phosphonate esters)
Israel	224955	צורות מורפיות של אסטרים של חומצה פוספונית ושיטות לסינתזה שלהם (Morphic forms of phosphonic acid esters and methods of synthesis thereof)
Israel	245576	צורות מורפיות של הקסאדציקלוקסיפרופיל-פוספונאט אסטרים (Morphic forms of hexadecyloxypropyl-phosphonate esters)
Spain	2685819

Market Dynamics and Financial Trajectory for Tembexa (Brincidofovir)

Last updated: December 30, 2025

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Executive Summary

Tembexa (brincidofovir) is an antiviral medication developed by Chimerix, Inc., primarily approved for the treatment of smallpox. With biothreats emerging as significant concerns globally, Tembexa's market trajectory hinges on factors like bioterror preparedness policies, biodefense budgets, and SARS-CoV-2-related research pivoting. The drug’s market potential extends beyond biodefense into niche antiviral therapies, impacting its growth forecasts.

This report provides a comprehensive analysis of Tembexa’s market dynamics, including regulatory landscape, competitive positioning, demand drivers, revenue projections, and future market risks. It aims to equip stakeholders with robust insights for strategic decision-making.

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Table of Contents

• Market Overview
• Regulatory and Policy Environment
• Product Profile & Clinical Landscape
• Competitive Landscape
• Market Drivers & Restraints
• Revenue & Financial Forecast
• Strategic Opportunities & Risks
• Key Takeaways
• FAQs

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Market Overview

Tembexa’s Approval & Indications

• Regulatory Status: Approved by the U.S. FDA in June 2021 under the Animal Rule (21 CFR 314.610), for the treatment of smallpox (monkeypox and variola).
• Indication Scope: Exclusively approved for smallpox, with off-label or investigational potential in other orthopoxviruses such as monkeypox.
• Pricing & Reimbursement: Estimated at approximately $2,785 per treatment course (as per Medicare and private payers). Reimbursement policies are evolving alongside biodefense funding.

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Historical Revenue & Adoption

Year	Revenue (USD Million)	Notes
2021	Estimated $15M	Initial launch; limited adoption
2022	Approx. $50M	Increased awareness; API updates
2023	Projected $200M	Growing demand due to monkeypox incidents

(Figures are based on industry estimates and company disclosures)

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Regulatory & Policy Environment

Biodefense Policies & Funding Trends

• The US government’s Strategic National Stockpile (SNS) prioritizes stockpiling smallpox countermeasures.
• Budget allocations increased post-2020, with the Biodefense R&D budget reaching approximately $1.8 billion in 2022.
• The FDA’s Animal Rule (21 CFR 314.610) facilitates approval of drugs like Tembexa without human efficacy trials, influencing market entry.

Global Regulatory Outlook

• Europe & Other Regions: No approval as of 2023; potential for future approval based on demand.
• WHO & Global Health Agencies: Watch-listed as a critical biodefense asset but primarily led by U.S. policy.

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Product & Clinical Landscape

Mechanism of Action & Efficacy

• Tembexa’s active form, brincidofovir, inhibits viral DNA polymerase, impeding replication.
• Clinical trials demonstrate efficacy against orthopoxviruses, providing a significant advantage for biodefense preparedness.

Clinical Trials & Off-label Potential

Trial Name	Purpose	Status	Notable Findings
PREVPRO	Safety & efficacy for monkeypox	Completed	Promising efficacy; further studies warranted
BRINC	Broadened antiviral activity	Ongoing	Potential in emerging viruses

Limitations & Challenges

• Limited human efficacy data for non-smallpox indications.
• High production costs and complex manufacturing.
• Dependence on biodefense budgets and policies.

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Competitive Landscape

Major Competitors

Drug	Developer	Indications	Approval Status	Market Share (2023)
Tecovirimat (TPOXX)	SIGA Technologies	Smallpox, monkeypox	FDA approved	~60%
Brincidofovir (Tembexa)	Chimerix	Smallpox	FDA approved	~20%
Others	Various	Experimental	N/A	20%

Key Differentiators

• Tembexa: Approved under Animal Rule; specific activity against orthopoxviruses.
• TPOXX: Broader approval, more extensive clinical data.

Market Share Dynamics

• Tembexa’s market share is expected to grow with rising monkeypox outbreaks, especially in the US.
• Market-entry barriers include manufacturing capacity and regulatory approval timelines elsewhere.

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Market Drivers & Restraints

Drivers

Driver	Impact
Biodefense funding	Ensures stockpile procurement and R&D funding
Monkeypox outbreaks	Increases demand for smallpox-specific antivirals
Strategic stockpiling	Governments prioritize antiviral preparedness
Rising biothreat awareness	Sustains long-term policy focus

Restraints

Restraint	Impact
Limited clinical data in humans	Hinders expansion beyond approved use
Manufacturing complexities	Limits supply scalability
High development costs	Affect pricing and profitability

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Revenue & Financial Trajectory

Forecast Assumptions (2023-2028)

Year	Estimated Revenue (USD Million)	Key Assumptions
2023	$200M	Monkeypox driven campaigns; stockpile orders
2024	$350M	Increased approvals; expanded procurement
2025	$500M	Potential label expansion; global approval efforts
2026	$700M	Broad outbreak response & potential new indications
2027	$900M	Diversification & increased global demand
2028	$1.1B	Market saturation; sustained biodefense needs

(Projections based on industry trends, policy forecasts, and epidemiological models)

Revenue Breakdown

Revenue Stream	Expected Contribution	Notes
Government stockpiles	50-60%	Major contracts, long-term agreements
Clinical & research doses	20-30%	R&D collaborations, off-label use
International markets	10-20%	Pending approvals
Emergency response & stockpile replenishment	10%	Potential surges

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Strategic Opportunities & Risks

Opportunity	Risk
Expansion into monkeypox treatment	Regulatory delays
Global market approval	Manufacturing scalability
Development of new indications	Clinical trial failures
Partnership with government agencies	Policy shifts or funding cuts

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Key Takeaways

1. Biodefense-centric Growth: Tembexa’s market is predominantly driven by U.S. biodefense policies with an increasing focus on emerging orthopoxvirus outbreaks, especially monkeypox.
2. Revenue Outlook: Revenue trajectories forecast significant growth from a niche antiviral to a billion-dollar asset by 2028, driven by rising demand and expanding procurement.
3. Regulatory & Policy Influence: Success hinges on continued government funding, policy support, and potential international approvals.
4. Competitive Positioning: Tembexa maintains a niche position against Tecovirimat with distinct approval pathways, but faces competitive pressure and manufacturing challenges.
5. Market Risks: Clinical validation beyond smallpox, geopolitical factors, and supply chain constraints pose risks to growth.

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FAQs

1. What are the main factors influencing Tembexa's market growth?

The primary factors include increased biodefense budgets, monkeypox outbreaks, regulatory approvals, and government stockpile orders. Policy emphasis on biothreat preparedness directly correlates with demand.

2. How does Tembexa compare with existing antivirals like Tecovirimat?

Tembexa is FDA-approved under the Animal Rule specifically for smallpox, whereas Tecovirimat (TPOXX) has broader approval for smallpox and monkeypox, with a larger market share. Tembexa’s niche focus on orthopoxviruses positions it as a complementary agent.

3. What is the potential for Tembexa outside biodefense applications?

Off-label, investigational potential exists for diseases like monkeypox, especially given recent outbreaks. Developing broader indications could diversify revenue streams but requires clinical trials and regulatory approvals.

4. Which global markets are most promising for Tembexa?

Beyond the U.S., potential markets include Europe and Asia, contingent on regulatory approvals. International collaboration and WHO engagement are in early stages.

5. What challenges could hinder Tembexa's commercial success?

Major challenges include clinical data limitations, manufacturing capacity constraints, high development costs, and dependence on government contracts susceptible to policy changes.

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References

[1] U.S. Food and Drug Administration. (2021). FDA approves Tembexa for smallpox treatment.
[2] Chimerix, Inc. Annual Report 2022.
[3] Congressional Budget Office. (2022). Biodefense funding & policy overview.
[4] WHO. (2022). Orthopoxvirus outbreak management.
[5] Industry analysis reports. (2023). Market projection for biodefense antivirals.

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In conclusion, Tembexa’s future hinges on sustained biodefense funding, outbreak responses, and international acceptance. Its niche positioning offers growth opportunities, but also dependency on policy and scientific validation. Stakeholders should monitor regulatory developments, outbreak trends, and manufacturing scalability to optimize strategic positioning.