XENLETA Drug Patent Profile

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

Xenleta is a drug marketed by Hong Kong and is included in two NDAs. There are four patents protecting this drug.

This drug has one hundred and nineteen patent family members in thirty-six countries.

The generic ingredient in XENLETA is lefamulin acetate. One supplier is listed for this compound. Additional details are available on the lefamulin acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Xenleta

Xenleta was eligible for patent challenges on August 19, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 25, 2033. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for XENLETA

International Patents:	119
US Patents:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	2
Patent Applications:	16
Drug Prices:	Drug price information for XENLETA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XENLETA
What excipients (inactive ingredients) are in XENLETA?	XENLETA excipients list
DailyMed Link:	XENLETA at DailyMed

See drug prices for XENLETA

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

NDA:

211673

Dosage:

SOLUTION;INTRAVENOUS

NDA:

211672

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 XENLETA

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

Sponsor	Phase
Nabriva Therapeutics AG	Phase 1
Nabriva Therapeutics AG	Phase 1/Phase 2
University of Washington	Phase 1/Phase 2

See all XENLETA clinical trials

Pharmacology for XENLETA

Drug Class	Pleuromutilin Antibacterial Anti-coagulant Calculi Dissolution Agent
Mechanism of Action	Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity

US Patents and Regulatory Information for XENLETA

XENLETA is protected by four US patents and two FDA Regulatory Exclusivities.

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
Hong Kong	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019		RX	Yes	Yes			Y
Hong Kong	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019		RX	Yes	Yes			Y	Y
Hong Kong	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019		RX	Yes	Yes
Hong Kong	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019		RX	Yes	Yes			Y	Y
Hong Kong	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019		RX	Yes	Yes			Y	Y
Hong Kong	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019		RX	Yes	Yes			Y	Y
Hong Kong	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019		RX	Yes	Yes			Y	Y

Expired US Patents for XENLETA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hong Kong	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019
Hong Kong	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019

International Patents for XENLETA

When does loss-of-exclusivity occur for XENLETA?

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

Australia

Austria

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Morocco

Netherlands

New Zealand

Norway

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

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 XENLETA around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2620459
European Patent Office	1305282	DERIVES DE PLEUROMUTILINE PRESENTANT UNE ACTIVITE ANTIBACTERIENNE (PLEUROMUTILIN DERIVATIVES HAVING ANTIBACTERIAL ACTIVITY)
Hong Kong	1052683
Eurasian Patent Organization	200970868
Czech Republic	200342
Austria	408596
Taiwan	201716056

Supplementary Protection Certificates for XENLETA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2137143	54/2020	Austria		PRODUCT NAME: LEFAMULIN, SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/20/1457 (MITTEILUNG) 20200728
2137143	20C1053	France		PRODUCT NAME: LEFAMULINE; NAT. REGISTRATION NO/DATE: EU/1/20/1457 20200728; FIRST REGISTRATION: FR - EU/1/20/1457 20200728
2137143	132020000000167	Italy		PRODUCT NAME: LEFAMULINA SUOI SALI E SOLVATI(XENLETA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1457, 20200728
2137143	780	Finland
2137143	122020000080	Germany		PRODUCT NAME: LEFAMULIN, DESSEN SALZE UND DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/20/1457 20200727
2137143	301086	Netherlands		PRODUCT NAME: LEFAMULINE, ALSMEDE ZOUTEN EN SOLVATEN ERVAN; REGISTRATION NO/DATE: EU/1/20/1457 20200728
2137143	PA2020531	Lithuania		PRODUCT NAME: LEFAMULINAS, JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/20/1457 20200727

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: XENLETA

Last updated: July 28, 2025

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Introduction

XENLETA (lefamulin) is a novel antibiotic developed for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Since its FDA approval in August 2019, XENLETA has marked a significant advancement in antimicrobial therapy, offering a new mechanism of action and a targeted treatment alternative amidst rising antibiotic resistance. Analyzing its market dynamics and financial trajectory involves evaluating regulatory landscape, competitive positioning, commercial performance, and emerging trends shaping its growth prospects.

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Regulatory and Market Launch Overview

XENLETA, developed by Allergan (now part of AbbVie following the 2020 acquisition), received FDA approval on August 21, 2019, under the Qualified Infectious Disease Product (QIDP) designation, enabling fast-tracked review and potential priority review benefits. The drug primarily targets CABP and ABSSSI, diseases with significant market sizes driven by high incidence rates globally. In the U.S., CABP alone affects approximately 5 million cases annually, representing a considerable addressable market segment.

Europe and other territories are progressing through regulatory filings, with Germany’s approvals and ongoing submissions in other markets extending XENLETA's geographical footprint. Such regulatory milestones significantly influence the drug’s commercial reach and financial outlook.

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Market Dynamics

Competitive Landscape

XENLETA enters a highly competitive antibiotic market dominated by established classes such as macrolides (azithromycin), β-lactams, fluoroquinolones, and tetracyclines. Its unique binding to the bacterial PTC (peptidyl transferase center) of the ribosome offers a mechanism less affected by common resistance pathways, creating potential differentiation.

However, entrenched competition from drugs like Pfizer's Zithromax, Merck's Bactrim, and emerging agents like omadacycline and lefamulin’s potential successors restrict immediate market penetration. Moreover, physician prescribing behaviors ingrained over decades challenge new entrants’ adoption rates.

Resistance and Stewardship Impact

Antibiotic resistance is an acute factor influencing XENLETA’s market trajectory. Its activity against resistant strains like MRSA (methicillin-resistant Staphylococcus aureus) enhances its value proposition. As stewardship programs promote targeted and judicious antibiotic use, drugs with novel mechanisms such as lefamulin are likely to see increased healthcare provider interest, especially in resistant infections.

Pricing and Reimbursement

Pricing strategies for XENLETA are aligned with premium antibiotic agents, often ranging between $2,000 to $3,000 per treatment course. Reimbursement policies, especially in the U.S., hinge on formulary inclusion, CDC and provider advocacy, and cost-effectiveness evidence. Initial negotiations with hospital formularies revealed cautious acceptance due to its premium pricing and competition.

Distribution and Adoption Drivers

Market adoption depends on hospital formulary placements, physician familiarity, and clinical evidence supporting superior outcomes. The delivery method—intravenous and oral formulations—facilitates outpatient and inpatient use, broadening its utilization scope.

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Financial Trajectory

Sales Performance and Revenue Trends

Since launch, XENLETA’s sales have shown gradual growth, attributed to limited awareness, moderate prescribing inertia, and competition. Year-over-year revenue during the initial years approximated $50 million, with projections estimating a compound annual growth rate (CAGR) of 20–25%, contingent on expanding indications and geographic expansion.

Market Penetration Milestones

AbbVie’s strategic efforts include clinical education, launching companion diagnostic tools, and expanding indications. Its health-economic data demonstrating reduced hospitalization and faster clinical recovery potentially support wider payer acceptance and reimbursement, bolstering sales.

Potential Revenues and Growth Drivers

• Indication Expansion: Including intra-abdominal infections or other resistant bacterial infections.
• Geographic Expansion: Europe, Asia-Pacific, and emerging markets offer significant revenue potential, provided regulatory approvals.
• Line Extensions: Development of oral formulations, combination therapies, or long-acting versions could enhance patient compliance and adherence, translating into increased market share.

Challenges and Risks

• Generic Competition: The threat of generic antibiotics could pressure pricing and margins after patent expiry.
• Resistance Development: Bacterial adaptation might limit efficacy over time.
• Pipeline Competition: Rapid innovation in antibiotics and alternative therapies could diminish XENLETA’s market share.

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Forward-Looking Outlook

The trajectory for XENLETA hinges on sustained clinical evidence, strategic market expansion, and balanced pricing strategies. Currently, rising global antibiotic resistance and healthcare cost pressures favor value-driven antibiotics like lefamulin. The drug’s potential in resisting resistant strains positions it as a strategic asset within hospital formularies, particularly amid increasing stewardship efforts.

AbbVie's investments in physician education, evidence generation, and new indications are critical to realizing revenue targets projected between $250 million and $500 million within the next five years, assuming successful market penetration and approval in key regions.

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Key Market Trends and Opportunities

• Emerging Resistance: Growing resistance to macrolides and fluoroquinolones boosts demand for new agents like lefamulin.
• Shift to Outpatient Care: Oral formulations enable outpatient management of pneumonia, expanding the market.
• Precision Medicine: Tailoring antibiotic therapy based on resistance profiles enhances the role of targeted drugs like XENLETA.
• Healthcare Infrastructure: Increased hospital capacity and diagnostic capabilities facilitate faster adoption.

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Conclusion

XENLETA’s market dynamics are shaped by its innovative mechanism, resistance tackling capacity, competitive landscape, and evolving healthcare paradigms emphasizing antibiotic stewardship. Its financial trajectory is cautiously optimistic, driven by strategic geographic expansion, indication growth, and clinical validation.

Realizing its full market potential will depend on regulatory successes outside the U.S., robust payer acceptance, and continued differentiation from existing antibiotics. With antibacterial resistance projected to escalate, XENLETA is positioned as a promising asset, provided it maintains clinical and commercial relevance amid fast-changing antimicrobial landscapes.

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Key Takeaways

• Innovation and Resistance: XENLETA’s novel mechanism positions it favorably against resistant pathogens, a critical driver amid rising antimicrobial resistance globally.
• Market Expansion: Geographical and indication-specific growth, including broader infection types, are vital to achieving projected revenues.
• Pricing and Adoption: Competitive pricing strategies, supported by clinical data demonstrating superior outcomes, are essential for formulary inclusion and market penetration.
• Pipeline and Differentiation: Ongoing development of formulations, combination therapies, and pipeline indications will influence its long-term market position.
• Competitive Dynamics: Staying ahead requires continuous innovation, strategic partnerships, and educating prescribers on lefamulin’s benefits.

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FAQs

1. What is the primary differentiation of XENLETA compared to other antibiotics?
XENLETA’s unique binding to the bacterial ribosomal PTC provides activity against resistant strains, including some MRSA, and offers both intravenous and oral formulations, facilitating outpatient management.

2. What are the main barriers to XENLETA’s market growth?
Interstitial challenges include pricing competition, entrenched prescribing habits, limited awareness, and the threat of generic equivalents post-patent expiry.

3. How does resistance influence XENLETA’s market prospects?
Its activity against resistant bacteria enhances its clinical utility, especially as stewardship programs favor targeted, resistance-bypassing antibiotics, potentially increasing demand.

4. Which markets offer the most growth opportunity for XENLETA?
North America and Europe are initial focus areas; however, markets in Asia-Pacific and Latin America present substantial long-term growth due to rising antibiotic resistance and infectious disease burden.

5. What strategies are key for XENLETA to sustain growth?
Expanding indications, geographical presence, optimizing pricing and reimbursement, and investing in clinician education are vital to maintaining and growing its market share.

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References

1. U.S. Food and Drug Administration. (2019). FDA approves new antibiotic to treat community-acquired bacterial pneumonia.
2. AbbVie Corporate Reports. (2022). Financial performance and strategic outlook for XENLETA.
3. MarketWatch. (2022). Antibiotic market analysis and forecasts.
4. CDC. (2021). Antibiotic resistance threats in the United States.
5. EvaluatePharma. (2022). Pharmaceutical sales forecasts and pipeline insights.