ZOLIFLODACIN - Generic Drug Details

What are the generic 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.

One supplier is listed for this compound.

Summary for ZOLIFLODACIN

International Patents:	62
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
Patent Applications:	40
DailyMed Link:	ZOLIFLODACIN at DailyMed

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.

Recent Clinical Trials for ZOLIFLODACIN

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

Sponsor	Phase
KCAS	Phase 1
Global Antibiotics Research and Development Partnership	Phase 1
Parexel	Phase 1

See all ZOLIFLODACIN clinical trials

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
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

International Patents for ZOLIFLODACIN

Country	Patent Number	Title	Estimated Expiration
Uruguay	32174	NUEVOS HETEROCICLOS SUSTITUIDOS, COMPOSICIONES FARMACEUTICAS CONTENIENDOLOS, PROCEDIMIENTOS DE PREPARACION Y APLICACIONES
Cyprus	1122805
World Intellectual Property Organization (WIPO)	2014114929
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
Japan	2012505261

Market Dynamics and Financial Trajectory for Zoliflodacin

Last updated: February 19, 2026

What is the Current Market Position of Zoliflodacin?

Zoliflodacin is an investigational oral antibiotic developed by Entasis Therapeutics, targeting sexually transmitted infection gonorrhea caused by antibiotic-resistant Neisseria gonorrhoeae. Its market entry has been prioritized due to rising antimicrobial resistance (AMR) and the decline of existing therapies.

The drug received Fast Track designation from the FDA in 2018 and has completed Phase 2 clinical trials, with Phase 3 trials ongoing as of 2023. It is positioned primarily as a treatment for uncomplicated gonorrhea, targeting a high unmet need in the face of increasing resistant strains.

What Are the Key Market Drivers?

• Antimicrobial Resistance: Gonorrhea's resistance to cephalosporins and fluoroquinolones prompts demand for novel oral therapies.
• Public Health Priority: WHO classifies gonorrhea as a high-priority pathogen, increasing regulatory and funding support for new treatments.
• Clinical Data: Demonstration of efficacy comparable or superior to existing treatments in Phase 2 shows potential for approval and adoption.
• Diagnostic Advances: Rapid testing facilitates appropriate use of new antibiotics, expanding market access.

What Is the Market Size and Growth Potential?

The global gonorrhea market, primarily comprising antibiotics and diagnostics, is estimated at $700 million in 2022. Expected compound annual growth rate (CAGR) is approximately 8% through 2030, driven by:

• Increased infection rates globally.
• Rising antibiotic resistance.
• Introduction of new therapeutics like Zoliflodacin.

Zoliflodacin's market penetration is projected to reach $300 million within five years of approval, assuming successful Phase 3 outcomes, low resistance development, and favorable reimbursement policies.

How Do Regulatory and Competitive Factors Influence Financial Outlook?

• Regulatory Approvals: FDA approval anticipated by 2024, with EMA approval following, could open access in key markets.
• Pricing Strategy: Price set between $50–$100 per dose based on clinical value, with payor negotiations influencing revenue.
• Competition: Existing treatments include ceftriaxone and azithromycin. However, rising resistance positions Zoliflodacin as a first-line alternative if approved.
• Market Access and Reimbursement: Policies favor innovative antibiotics for resistant infections, supporting higher reimbursement levels.

What Are the Risks and Opportunities?

Risks:

• Regulatory Delays: Possible delays in Phase 3 results or approval.
• Resistance Development: Potential emergence of resistance could limit long-term utility.
• Market Penetration: Clinician adoption depends on clinical guidelines and reimbursement policies.
• Manufacturing Scale-up: Meeting demand post-approval could face challenges.

Opportunities:

• Expanding Indications: Potential for other genital infections or resistant strains.
• Partnerships: Collaborations with public health agencies or global health initiatives.
• Global Market Access: Developing markets with high STI prevalence provide growth avenues.

Financial Trajectory Projections

Year	Estimated Revenue	Market Penetration	Notes
2024	$0	Pre-approval	Clinical trials ongoing
2025	$50 million	Limited launch	Post-approval, early access in select markets
2026	$150 million	Initial adoption	Growing clinician acceptance, insurance coverage
2027	$300 million	Moderate penetration	Broader market presence

Projections assume successful Phase 3 results, FDA approval, and steady adoption based on unmet need. Revenues may increase or decrease based on resistance trends, competition, and regulatory outcomes.

Key Takeaways

• Zoliflodacin targets an unmet need in resistant gonorrhea with high market potential.
• Revenue depends significantly on successful regulatory approval and clinician adoption.
• Market growth hinges on antimicrobial resistance developments and global health policies.
• Risks include regulatory delays, resistance development, and market access hurdles.
• Opportunities exist in expanding indications and global markets.

FAQs

What stage is Zoliflodacin in?
As of 2023, Zoliflodacin is completing Phase 3 clinical trials with FDA approval expected in 2024.

What is the expected market size upon approval?
The initial target market could generate approximately $300 million annually within five years, contingent on clinical success and adoption.

How does resistance impact its potential?
Rising resistance to current therapies increases demand for Zoliflodacin, but the emergence of resistance to Zoliflodacin itself could limit its long-term utility.

Are there competitors in late-stage development?
Few direct competitors are in late-stage development specifically for gonorrhea; most focus on existing antibiotics, reinforcing Zoliflodacin’s market opportunity.

What factors influence pricing?
Pricing is influenced by clinical efficacy, manufacturing costs, reimbursement negotiations, and comparators' prices, estimated between $50–$100 per dose.

References

1. World Health Organization. (2021). Global health sector strategy on sexually transmitted infections 2021–2030.
2. U.S. Food and Drug Administration. (2023). Zoliflodacin Fast Track designation.
3. Entasis Therapeutics. (2022). Phase 2 clinical trial data on Zoliflodacin.
4. Grand View Research. (2022). Gonorrhea treatment market size and forecast.
5. IQVIA. (2022). Global antimicrobial market analysis.