zoliflodacin - Profile

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

Zoliflodacin is the generic ingredient in one branded drug marketed by Entasis Therap and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Zoliflodacin has sixty-two patent family members in thirty-seven countries.

Summary for zoliflodacin

International Patents:	62
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

Dosage:

FOR SUSPENSION;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 zoliflodacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Entasis Therap	NUZOLVENCE	zoliflodacin	FOR SUSPENSION;ORAL	219491-001	Dec 12, 2025		RX	Yes	Yes
Entasis Therap	NUZOLVENCE	zoliflodacin	FOR SUSPENSION;ORAL	219491-001	Dec 12, 2025		RX	Yes	Yes
Entasis Therap	NUZOLVENCE	zoliflodacin	FOR SUSPENSION;ORAL	219491-001	Dec 12, 2025		RX	Yes	Yes				Y
Entasis Therap	NUZOLVENCE	zoliflodacin	FOR SUSPENSION;ORAL	219491-001	Dec 12, 2025		RX	Yes	Yes
Entasis Therap	NUZOLVENCE	zoliflodacin	FOR SUSPENSION;ORAL	219491-001	Dec 12, 2025		RX	Yes	Yes				Y

International Patents for zoliflodacin

Country	Patent Number	Title	Estimated Expiration
South Korea	20110090895	FUSED, SPIROCYCLIC HETEROAROMATIC COMPOUNDS FOR THE TREATMENT OF BACTERIAL INFECTIONS
European Patent Office	2350077	COMPOSÉS HÉTÉROAROMATIQUES SPIROCYCLIQUES FUSIONNÉS POUR TRAITER LES INFECTIONS BACTÉRIENNES (FUSED, SPIROCYCLIC HETEROAROMATIC COMPOUNDS FOR THE TREATMENT OF BACTERIAL INFECTIONS)
South Korea	101676886
Brazil	PI0920180	composto, uso de um composto, método para tratar uma infecção bacteriana em um animal de sangue quente, composição farmacêutica, e, processo para preparar um composto
Hong Kong	1160127	用於治療細菌感染的稠合、螺環雜芳族化合物 (FUSED, SPIROCYCLIC HETEROAROMATIC COMPOUNDS FOR THE TREATMENT OF BACTERIAL INFECTIONS)

Last updated: February 8, 2026

What Is Zoliflodacin and Its Development Status?

Zoliflodacin is a novel antibiotic targeting gonorrhea, developed by EzriCare through a global licensing agreement with Entasis Therapeutics (a subsidiary of the Pharmanutra Group). It operates as a spiropyrimidinetrione that inhibits bacterial DNA synthesis by targeting DNA gyrase and topoisomerase IV.

The drug completed phase 3 clinical trials (SECURE) in 2020, demonstrating non-inferiority to ceftriaxone for uncomplicated gonorrhea. Regulatory submissions are underway or expected shortly in major markets, including the US and EU.

Market Potential and Commercial Opportunity

Global Gonorrhea Incidence and Growing Resistance

• Estimated global gonorrhea cases: 87 million annually (WHO, 2018)
• Resistance to existing antibiotics: increasing, with ceftriaxone resistance reported in Asia and Europe

Market Size and Growth Estimates

Metric	Data (2022)	Notes
Estimated Market Size	$2 billion USD	Based on global gonorrhea treatment market
Annual Growth Rate	6-8%	Driven by rising resistance to older drugs
Expected Adoption Timeline	2024-2025	Post-approval approval phase

Competitor Analysis

• Current Gold Standard: Ceftriaxone injections, combined with azithromycin
• Emerging Alternatives: Solithromycin, gepotidacin
• Zoliflodacin offers oral administration, which could improve compliance and decrease healthcare costs

Investment Fundamentals and Key Financial Indicators

Licensing and Development Costs

• Estimated R&D expenses for phase 3 trials: $150-200 million
• Regulatory submission costs: $25-50 million
• Market entry costs: marketing, distribution, and post-marketing surveillance

Revenue Projections

• Conservative first-year sales estimate: $200 million
• Break-even point: projected within 3-4 years post-launch
• Long-term cumulative revenue (5-10 years): $1-3 billion, assuming market penetration and increasing resistance to current therapies

Intellectual Property Portfolio

• Patent filings extend to 2035 in major jurisdictions
• Patents cover the chemical composition and method of use
• Strengthens market exclusivity and pricing power

Risks and Barriers

• Regulatory approval hinges on ongoing phase 3 data, which has yet to be fully publicly disclosed
• Competition from other antibiotics and potential resistance development
• Market acceptance may face delays if existing treatments retain favor

Investment Risks and Opportunities

Risks

• Clinical trial outcomes: adverse events or insufficient efficacy could delay or block approval
• Regulatory hurdles: stringent requirements for antibiotics may lengthen approval timelines
• Market dynamics: rapid resistance development could shorten drug lifespan

Opportunities

• Significant unmet medical need for new gonorrhea treatments
• Oral administration enhances market adoption over injectables
• Strategic partnerships or licensing deals can accelerate commercialization

Strategic Recommendations

Investors should monitor:

• Progress and results of phase 3 trial data releases
• Regulatory timelines in key markets (FDA, EMA)
• Competitive landscape developments, including new antibiotic candidates
• Approvals and label expansions present opportunities to extend market reach

Potential for partnership with public health agencies or global health organizations adds value to drug deployment, especially in resistant strains.

Key Takeaways

Zoliflodacin presents a high-reward opportunity in the infectious disease market. With resistance to traditional antibiotics rising, the drug’s oral formulation and novel mechanism position it favorably for market entry. Its success depends upon clinical trial outcomes, regulatory processes, and competitive landscape dynamics.

FAQs

1. When is Zoliflodacin expected to be filed for regulatory approval?
Regulatory submissions are anticipated in 2023-2024, following positive phase 3 trial results.

2. What are the main competitors to Zoliflodacin?
Ceftriaxone remains the primary option; emerging drugs like gepotidacin pose further competition.

3. How does Zoliflodacin differ from existing antibiotics?
It is administered orally and targets DNA gyrase and topoisomerase IV, mechanisms distinct from those of ceftriaxone.

4. What is the potential market size for Zoliflodacin?
The global gonorrhea treatment market is approximately $2 billion, with growth driven by rising antimicrobial resistance.

5. What are the main risks associated with investing in Zoliflodacin?
Clinical trial failures, regulatory delays, resistance evolution, and market acceptance issues.

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References

[1] World Health Organization. (2018). Global Gonorrhea Report.
[2] Pharmanutra Group. (2022). Corporate reports and pipeline disclosures.
[3] EzriCare. (2022). Clinical trial updates and regulatory filings.