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 three patents protecting this drug.

This drug has eighty-seven patent family members in thirty-four 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 August 19, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XENLETA

International Patents:	87
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	2
Patent Applications:	33
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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

211673

Dosage:

SOLUTION;INTRAVENOUS

Constraining patent/regulatory exclusivity:

9,120,727

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
University of Washington	Phase 1/Phase 2
Nabriva Therapeutics AG	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 three US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

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	8,071,643		Y	Y
Hong Kong	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019		RX	Yes	Yes	9,120,727		Y	Y
Hong Kong	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019		RX	Yes	Yes

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	6,753,445
Hong Kong	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019	6,753,445

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

Mexico

Morocco

Netherlands

New Zealand

Norway

Poland

Portugal

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Turkey

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
Denmark	3299356
Mexico	PA02012828	DERIVADOS DE PLEUROMUTILINA QUE TIENEN ACTIVIDAD ANTIBACTERIANA. (PLEUROMUTILIN DERIVATIVES HAVING ANTIBACTERIAL ACTIVITY.)

Supplementary Protection Certificates for XENLETA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2137143	PA2020531,C2137143	Lithuania		PRODUCT NAME: LEFAMULINAS, JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/20/1457 20200727
2137143	2090054-4	Sweden		PRODUCT NAME: LEFAMULIN, SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/20/1457 20200728
2137143	2020/053	Ireland		PRODUCT NAME: LEFAMULIN, SALTS AND SOLVATES THEREOF; NAT REGISTRATION NO/DATE: EU/1/20/1457 20200728; FIRST REGISTRATION NO/DATE: EU/1/20/1457 20200728

Market Dynamics and Financial Trajectory for XENLETA

Introduction

XENLETA (lefamulin acetate) is a groundbreaking antibiotic that has garnered significant attention in the pharmaceutical industry due to its innovative mechanism of action and its potential to address the growing issue of antimicrobial resistance. Here, we will delve into the market dynamics and financial trajectory of XENLETA, highlighting its development, commercialization, and financial performance.

Development and Approval

XENLETA belongs to a new class of antibiotics known as pleuromutilins, designed to combat community-acquired bacterial pneumonia (CABP) in adults. It has received global approvals, including in the U.S., for both intravenous and oral formulations[1][4].

The drug's efficacy was established through two pivotal Phase 3 trials, LEAP 1 and LEAP 2, where XENLETA met all primary endpoints and demonstrated non-inferiority to moxifloxacin in treating CABP[4].

Market Need and Positioning

The increasing prevalence of antibiotic resistance has created a significant market need for novel antibiotics like XENLETA. This drug offers a complete spectrum of coverage for the main CABP pathogens and has a low propensity for the development of bacterial resistance, making it a critical therapeutic option in the fight against antimicrobial resistance (AMR)[1].

XENLETA is positioned as a monotherapy option for both inpatient and outpatient settings, addressing over five million annual cases of CABP in the U.S. alone. Its unique and well-tolerated product profile makes it an attractive choice for healthcare providers[1].

Commercialization and Partnerships

The commercial rights for XENLETA in the U.S. were acquired by Meitheal Pharmaceuticals through an exclusive license and supply agreement with Hong Kong King-Friend Industrial Co., Ltd. (HKF), which had previously obtained global rights to XENLETA from Nabriva Therapeutics[1].

Nabriva Therapeutics had been actively expanding the presence of XENLETA globally through partnerships, such as the distribution agreement with Er-Kim Pharmaceuticals for territories outside the U.S.[2].

Financial Performance

Revenue and Sales

Nabriva Therapeutics reported modest revenue growth from XENLETA, although the drug's commercial performance was impacted by the COVID-19 pandemic. In the second quarter of 2022, XENLETA product revenue saw a slight increase, but overall, the revenue from XENLETA was overshadowed by the stronger performance of another antibiotic, SIVEXTRO[2].

For the six months ended June 30, 2022, XENLETA product revenue net decreased by $0.2 million compared to the same period in 2021, partly due to the pandemic's effects on commercial activities[2].

Research and Development Expenses

Research and development expenses for XENLETA have been significant, particularly for the Phase 1 cystic fibrosis trial and other life-cycle management opportunities. In the second quarter of 2022, these expenses increased by $0.7 million, driven by research materials and purchased services for the cystic fibrosis trial[2].

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses related to XENLETA have been substantial, reflecting the efforts to commercialize the drug. However, these expenses decreased by 14% in the second quarter of 2022 compared to the same period in 2021, primarily due to reduced advisory and external consultancy expenses[2].

Net Loss

Nabriva Therapeutics has incurred net losses, with a net loss of $11.1 million in the second quarter of 2022. Despite this, the company has managed to extend its cash runway through various financing activities and product sales[2].

Funding and Cash Flow

Nabriva Therapeutics has financed its operations through a combination of equity sales, debt financings, research and development support, and proceeds from licensing agreements and product sales. As of 2021, the company had generated negative cash flows from operations but managed to increase its cash resources through financing activities[5].

Market Expansion and Future Prospects

Meitheal Pharmaceuticals plans to leverage its existing marketing, sales, and medical science liaison teams to support the launch of XENLETA, aligning with their strategy for another anti-infective, CONTEPO. This approach is expected to unlock synergies and deliver critical medicines to address gaps in the antibiotic treatment landscape[1].

The global expansion of XENLETA, facilitated by partnerships like the one with Er-Kim Pharmaceuticals, is set to increase its market reach and potential revenue. Nabriva Therapeutics continues to explore life-cycle management opportunities, including trials for cystic fibrosis and drug-resistant sexually transmitted infections, which could further enhance the drug's value[3].

Key Takeaways

• Innovative Mechanism: XENLETA is a first-in-class semi-synthetic pleuromutilin antibiotic addressing antimicrobial resistance.
• Market Need: It fills a critical gap in treating CABP with a low propensity for resistance.
• Commercialization: Exclusive licensing agreements with Meitheal Pharmaceuticals and global partnerships are key to its market presence.
• Financial Performance: Modest revenue growth, significant R&D expenses, and ongoing efforts to manage net losses.
• Future Prospects: Continued market expansion, life-cycle management opportunities, and potential for increased revenue through strategic partnerships.

FAQs

What is XENLETA used for?

XENLETA (lefamulin acetate) is used for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

Who has the commercial rights for XENLETA in the U.S.?

Meitheal Pharmaceuticals has the exclusive commercial rights for XENLETA in the U.S. through an agreement with Hong Kong King-Friend Industrial Co., Ltd. (HKF)[1].

How has the COVID-19 pandemic affected XENLETA's commercial performance?

The pandemic has significantly impacted the commercial activities of XENLETA, leading to reduced sales and revenue growth compared to pre-pandemic levels[2][3].

What are the key financial challenges faced by Nabriva Therapeutics regarding XENLETA?

Nabriva Therapeutics has faced challenges including net losses, significant R&D expenses, and the need for continuous financing to support operations[2][5].

What are the future prospects for XENLETA?

XENLETA has promising future prospects with ongoing market expansion, life-cycle management opportunities, and potential trials for other indications such as cystic fibrosis and drug-resistant sexually transmitted infections[1][3].

Sources

1. Meitheal Pharmaceuticals Grows Specialty Biopharmaceuticals Portfolio with Exclusive Commercial Licensing Agreement for XENLETA (lefamulin acetate) - Biospace.
2. Nabriva Therapeutics Reports Second Quarter 2022 Financial Results and Provides a Corporate Update - Biospace.
3. Nabriva Therapeutics Provides Business Update and Announces Preliminary Financial Results for the Fourth Quarter of 2021 - Biospace.
4. Summary Basis of Decision for Xenleta - Health Canada.
5. NABRIVA THERAPEUTICS PLC MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS - Marketscreener.