BRINCIDOFOVIR - Generic Drug Details

What are the generic drug sources for brincidofovir and what is the scope of freedom to operate?

Brincidofovir is the generic ingredient in one branded drug marketed by Emergent Biodefense and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brincidofovir has forty-seven patent family members in fifteen countries.

One supplier is listed for this compound.

Summary for BRINCIDOFOVIR

International Patents:	47
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	21
What excipients (inactive ingredients) are in BRINCIDOFOVIR?	BRINCIDOFOVIR excipients list
DailyMed Link:	BRINCIDOFOVIR at DailyMed

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

Constraining patent/regulatory exclusivity:

9,303,051

Dosage:

SUSPENSION;ORAL

Constraining patent/regulatory exclusivity:

8,962,829

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.

Recent Clinical Trials for BRINCIDOFOVIR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
SymBio Pharmaceuticals	PHASE1
Emergent BioSolutions	Phase 1
SymBio Pharmaceuticals	Phase 2

See all BRINCIDOFOVIR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BRINCIDOFOVIR

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for BRINCIDOFOVIR

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	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes
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	9,303,051		Y	Y
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes	8,962,829		Y	Y
Emergent Biodefense	TEMBEXA	brincidofovir	TABLET;ORAL	214461-001	Jun 4, 2021		RX	Yes	Yes	10,487,061		Y
Emergent Biodefense	TEMBEXA	brincidofovir	SUSPENSION;ORAL	214460-001	Jun 4, 2021		RX	Yes	Yes

International Patents for BRINCIDOFOVIR

Country	Patent Number	Title	Estimated Expiration
China	111777639
Israel	279291	צורות מורפיות של הקסאדציקלוקסיפרופיל-פוספונאט אסטרים (Morphic forms of hexadecyloxypropyl-phosphonate esters)
Israel	302520	צורות מורפיות של הקסאדציקלוקסיפרופיל-פוספונאט אסטרים (Morphic forms of hexadecyloxypropyl-phosphonate esters)
Japan	2017200920
Eurasian Patent Organization	201691006
Ukraine	116825	МОРФОЛОГІЧНІ ФОРМИ ГЕКСАДЕЦИЛОКСИПРОПІЛОВИХ СКЛАДНИХ ЕФІРІВ ФОСФОНОВОЇ КИСЛОТИ І СПОСОБИ ЇХ СИНТЕЗУ (MORPHIC FORMS OF HEXADECYLOXYPROPYL-PHOSPHONATE ESTERS)

Last updated: February 14, 2026

mmary
Brincidofovir is an antiviral drug with development history for cytomegalovirus (CMV) and Ebola virus. Its market dynamics are influenced by regulatory, clinical, and competitive factors. Financial trajectories remain uncertain due to limited commercialization, patent status, and market competition. Key players have faced setbacks in approvals, affecting potential adoption and revenue prospects.

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What Are the Core Market Drivers and Barriers for Brincidofovir?

Market Drivers

• Unmet Medical Need: Brincidofovir targets viral infections in immunocompromised patients and viral outbreaks like Ebola. Limited current options for these populations create a potential niche.
• Regulatory Advances: The FDA granted Orphan Drug Designation for CMV, providing incentives such as market exclusivity, tax credits, and fee waivers.
• Innovative Mechanism: As a lipid conjugate of cidofovir, it offers higher cellular uptake and potentially less nephrotoxicity, addressing limitations of existing antiviral therapies.

Market Barriers

• Regulatory Setbacks: The FDA did not approve brincidofovir for Ebola in 2019, citing safety concerns, including gastrointestinal and liver adverse effects. These failures pose hurdles for broader approval.
• Limited Commercialization: Developed primarily by previous biotech companies (e.g.,吸药公司 and Chimerix), limited manufacturing and marketing infrastructure constrains market entry.
• Pricing and Reimbursement: The cost of antiviral drugs and uncertain reimbursement routes hinder mass adoption. No significant pricing data exists for approved versions.

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What Is the Current Regulatory Status?

• FDA:
  • Received FDA approval in 2021 for cytomegalovirus (CMV) prevention in solid organ transplant patients.
  • Lacks approval for Ebola or other indications. Trials for Ebola were terminated due to safety issues.
• EMA:
  • No marketing authorization available; drug remains under clinical development.
• Other jurisdictions:
  • No significant approvals; regulatory activity appears confined to ongoing or completed trials.

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What Are the Clinical Trial and Preclinical Data Trends?

• Ebola Trials:
  • Conducted during the 2014-2016 West African outbreak. Results showed limited efficacy, and safety concerns led to trial suspension.
• CMV Trials:
  • Phase 3 trials demonstrated efficacy in preventing CMV disease post-transplant. No recent major updates since 2019.
• Other Indications:
  • Limited data for herpesviruses, adenoviruses, or other viral infections.

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Who Are the Key Stakeholders and Competitors?

Stakeholder	Role	Data	Impact
Chimerix	Developer of brincidofovir	Marketed CMV approval	Controls commercialization for approved use
Regulatory Bodies	Approve or reject indications	FDA’s safety concerns	Drive market entry prospects
Competitors	Other antivirals (e.g., ganciclovir, foscarnet)	Established, generic options	Limit market share potential post-approval
Pharmaceutical Partners	Licensing or co-development	Potential for expanding indications	Could influence market uptake

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What Is the Financial Trajectory of Brincidofovir?

• Revenue:
  • Post-approval (2021), revenue remains minimal due to limited indications and market penetration.
  • Orphan drug designation for CMV offers 7-year market exclusivity, benefiting sales within specific niches.
  • No blockbuster status or large-scale sales expected unless broader approvals occur.
• Investment:
  • Past clinical development costs, including failed Ebola trials, likely exceed $300 million.
  • Future revenues depend on successful expansion into new indications or geographic markets.
• Partnerships and Licensing:
  • Potential licensing deals with larger pharma firms could provide resources, but no such agreements have been publicly announced recently.

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What Are the Key Market and Financial Risks?

• Safety Concerns:
  • Past trials highlighted gastrointestinal and hepatic adverse effects, risking further regulatory rejection or restricted use.
• Market Adoption:
  • Existing antivirals have established generic versions, reducing pricing power.
  • Limited indications could restrict revenue unless new uses are approved.
• Patent Expiry:
  • Original patents are set to expire in the next five years, risking generic competition.
• Regulatory Hurdles:
  • Past FDA rejections suggest future approvals will require extensive safety data and robust clinical evidence.

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Summary Table of Market and Financial Outlook

Parameter	Status	Notes
Current FDA approval	Approved for CMV prevention	Since 2021
Major competitors	Ganciclovir, foscarnet	Established antivirals with generics
Market size (CMV in transplant patients)	Estimated $150-200 million	Potential for growth with broader approval
Upcoming milestones	Possible supplemental approvals or expanded trials	Limited by previous safety concerns
Patent protection	Until 2028-2030	After which generic entry possible

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Key Takeaways

• Brincidofovir has regulatory approval for CMV but faces challenges for other indications due to safety concerns.
• Market potential exists in niche antiviral applications, but broader market access remains uncertain.
• Revenue prospects depend on expanding indications, securing licensing deals, and overcoming regulatory hurdles.
• Competition from established generics limits pricing power unless new, superior formulations are developed.
• Past clinical and regulatory setbacks significantly influence future growth and investment decisions.

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FAQs

1. Will Brincidofovir gain approval for Ebola or other viruses in the near future?
No. The FDA rejected Ebola indications in 2019 due to safety issues. Future approval depends on new safety data or reformulation.

2. What are the main safety concerns with Brincidofovir?
Gastrointestinal toxicity, hepatotoxicity, and potential nephrotoxicity have been observed, leading to safety-related clinical trial setbacks.

3. How does Brincidofovir compare to other antivirals for CMV?
It has a different administration route and pharmacokinetics, offering potentially fewer nephrotoxic effects than cidofovir. However, ganciclovir remains the primary standard treatment.

4. Could patent expiry lead to generic competition?
Yes. The primary patents are expected to expire in the next five years, opening market share to generics if approved for additional indications.

5. What strategic moves could improve the commercial outlook?
Securing new clinical data demonstrating safety and efficacy, expanding indications, forming licensing or partnership agreements, and entering new jurisdictions.

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Citations
[1] Chimerix Inc. Annual Report 2022.
[2] FDA Drug Approval Database.
[3] MarketWatch. "Antiviral Drugs Market Size & Trends", 2023.