Lefamulin acetate - Generic Drug Details

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

Lefamulin acetate is the generic ingredient in one branded drug marketed by Nabriva and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lefamulin acetate has eighty-seven patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for lefamulin acetate

International Patents:	87
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Patent Applications:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lefamulin acetate
What excipients (inactive ingredients) are in lefamulin acetate?	lefamulin acetate excipients list
DailyMed Link:	lefamulin acetate at DailyMed

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

Dosage:

SOLUTION;INTRAVENOUS

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.

Pharmacology for lefamulin acetate

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

Anatomical Therapeutic Chemical (ATC) Classes for lefamulin acetate

J01XX	Other antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for lefamulin acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nabriva	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019		RX	Yes	Yes
Nabriva	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019		RX	Yes	Yes			Y	Y
Nabriva	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019		RX	Yes	Yes			Y	Y
Nabriva	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019		RX	Yes	Yes
Nabriva	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019		RX	Yes	Yes
Nabriva	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019		RX	Yes	Yes

Expired US Patents for lefamulin acetate

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

International Patents for lefamulin acetate

Country	Patent Number	Title	Estimated Expiration
Japan	5893651
New Zealand	579011	PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES
Portugal	3299356
Portugal	2137143
South Africa	201208056	PROCESS FOR THE PREPARATION OF PLEUROMUTILINS
Japan	2010522143

Supplementary Protection Certificates for lefamulin acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2137143	2090054-4	Sweden		PRODUCT NAME: LEFAMULIN, SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/20/1457 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	54/2020	Austria		PRODUCT NAME: LEFAMULIN, SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/20/1457 (MITTEILUNG) 20200728
2137143	301086	Netherlands		PRODUCT NAME: LEFAMULINE, ALSMEDE ZOUTEN EN SOLVATEN ERVAN; REGISTRATION NO/DATE: EU/1/20/1457 20200728
2137143	SPC/GB20/052	United Kingdom		PRODUCT NAME: LEFAMULIN, OPTIONALLY IN THE FORM OF A SALT AND/OR SOLVATE THEREOF; REGISTERED: UK EU/1/20/1457 (NI) 20200728; UK PLGB 53672/0001 20200728; UK PLGB 53672/0002 20200728
2137143	122020000080	Germany		PRODUCT NAME: LEFAMULIN, DESSEN SALZE UND DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/20/1457 20200727

Lefamulin acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lefamulin Acetate

Introduction

Lefamulin acetate, marketed as XENLETA®, is a groundbreaking antibiotic that has marked a significant milestone in the fight against community-acquired bacterial pneumonia (CABP). Here, we delve into the market dynamics and financial trajectory of this innovative drug.

Mechanism of Action and Unique Selling Points

XENLETA® is a first-in-class, semi-synthetic pleuromutilin antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. This unique mechanism of action reduces the likelihood of developing resistance and cross-resistance, making it a critical tool in addressing antimicrobial resistance (AMR)[1][2][5].

Regulatory Approvals

Lefamulin acetate has received regulatory approvals in several key markets. It was first approved by the U.S. FDA in August 2019 for the treatment of CABP in adults, both in intravenous and oral formulations. Subsequent approvals have been granted by Health Canada, the European Commission, and more recently in China by the National Medical Products Administration (NMPA) in November 2023[1][2][5].

Market Expansion and Licensing Agreements

The global rights to XENLETA®, excluding Greater China, were acquired by Hong Kong King-Friend Industrial Co., Ltd. (HKF) from Nabriva Therapeutics. Meitheal Pharmaceuticals, through an exclusive license and supply agreement with HKF, has added XENLETA® to its portfolio, enhancing its presence in the specialty biopharmaceuticals market[1].

In China, Sumitomo Pharma (Suzhou) Co., Ltd. obtained the exclusive development and commercialization rights for XENLETA® and has recently received approval for its use in treating CABP[2].

Market Growth and Projections

The lefamulin market is poised for significant growth. The global market size is expected to expand substantially from 2023 to 2031, driven by increasing demand for effective antibiotics and the unique advantages of lefamulin acetate. The market is segmented by type (oral and injection) and application (medicine and scientific research), with North America, Europe, and the Asia-Pacific region being key geographical markets[3].

Financial Performance and Challenges

Despite its innovative status and regulatory approvals, Nabriva Therapeutics, the original developer of lefamulin, faced significant financial challenges. The company reported minimal sales in the first quarter of 2020, and its stock price plummeted, leading to layoffs and a shift in sales strategy. The company's ability to turn a profit on lefamulin has been a persistent challenge, a common issue for many independent antibiotic developers[5].

However, with the licensing agreements and partnerships in place, the financial outlook for lefamulin acetate is improving. Meitheal Pharmaceuticals and Sumitomo Pharma are leveraging their resources and expertise to commercialize XENLETA® more effectively, which is expected to enhance its market penetration and revenue generation[1][2].

Manufacturing and Production Efficiencies

The production process for lefamulin acetate is being continuously refined by contract manufacturing firms such as Hovione and Almac. These efforts aim to reduce waste, improve efficiency, and increase manufacturing capacity. For instance, Hovione is working on continuous solvent extraction to decrease solvent usage, and Almac is transitioning the granulation process for XENLETA tablets from pilot to commercial scale[5].

Market Dynamics: Drivers and Restraints

Drivers

• Unmet Medical Need: Lefamulin acetate addresses a significant unmet medical need by providing a novel antibiotic with a low propensity for resistance, which is crucial in the face of rising AMR[1][5].
• Regulatory Approvals: Multiple regulatory approvals in key markets have paved the way for its widespread adoption.
• Partnerships and Licensing: Strategic partnerships with companies like Meitheal Pharmaceuticals and Sumitomo Pharma are enhancing its market reach and commercialization efforts[1][2].

Restraints

• Financial Challenges: The initial financial struggles faced by Nabriva Therapeutics highlight the difficulties in turning a profit on antibiotic development, especially for independent biotech firms[5].
• Market Competition: The antibiotic market is highly competitive, and gaining traction can be challenging, especially during periods like the COVID-19 pandemic when hospital interactions were restricted[5].

Conclusion

Lefamulin acetate, as XENLETA®, represents a significant advancement in the treatment of CABP and a critical step in combating AMR. Despite initial financial challenges, the drug's market dynamics are improving with strategic partnerships and ongoing production efficiencies. As the market continues to grow, XENLETA® is poised to become a vital component in the antibiotic treatment landscape.

Key Takeaways

• Innovative Mechanism: XENLETA® has a unique mechanism of action that reduces the likelihood of resistance.
• Global Approvals: Approved in multiple countries, including the U.S., Europe, and China.
• Market Growth: Projected significant growth from 2023 to 2031.
• Partnerships: Licensing agreements with Meitheal Pharmaceuticals and Sumitomo Pharma are enhancing commercialization efforts.
• Financial Challenges: Initial financial struggles faced by Nabriva Therapeutics, but improving with new partnerships.

FAQs

What is lefamulin acetate used for?

Lefamulin acetate, marketed as XENLETA®, is used for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

What makes lefamulin acetate unique?

Lefamulin acetate has a novel mechanism of action that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, reducing the likelihood of developing resistance and cross-resistance.

Who are the key players involved in the commercialization of lefamulin acetate?

Key players include Nabriva Therapeutics, Meitheal Pharmaceuticals, Hong Kong King-Friend Industrial Co., Ltd. (HKF), and Sumitomo Pharma.

What are the regulatory approvals for lefamulin acetate?

Lefamulin acetate has been approved by the U.S. FDA, Health Canada, the European Commission, and the National Medical Products Administration (NMPA) in China.

What are the challenges faced by Nabriva Therapeutics in commercializing lefamulin acetate?

Nabriva Therapeutics faced significant financial challenges, including low sales and stock price issues, which led to layoffs and a shift in sales strategy.

Sources

1. Meitheal Pharmaceuticals Grows Specialty Biopharmaceuticals Portfolio with Exclusive Commercial Licensing Agreement for XENLETA (lefamulin acetate) - Biospace
2. Sumitomo Pharma Announces the Approval of XENLETA (lefamulin acetate) for the Treatment of Community-Acquired Pneumonia in China - Sumitomo Pharma
3. Global Lefamulin Market Size, Scope And Forecast Report - Market Research Intellect
4. Lefamulin Acetate - Drug Targets, Indications, Patents - Synapse
5. One molecule's journey from discovery to market - C&EN