ZELSUVMI Drug Patent Profile

When do Zelsuvmi patents expire, and what generic alternatives are available?

Zelsuvmi is a drug marketed by Lnhc and is included in one NDA. There are fourteen patents protecting this drug.

This drug has fifty-nine patent family members in nine countries.

The generic ingredient in ZELSUVMI is berdazimer sodium. Additional details are available on the berdazimer sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Zelsuvmi

Zelsuvmi will be eligible for patent challenges on January 5, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 5, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZELSUVMI

International Patents:	59
US Patents:	14
Applicants:	1
NDAs:	1
DailyMed Link:	ZELSUVMI at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217424

Dosage:

GEL;TOPICAL

^*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 ZELSUVMI

ZELSUVMI is protected by twenty-two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes	11,723,858		Y
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes	8,956,658			Y
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes	9,526,738		Y
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes	10,376,538		Y
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes	9,289,442		Y
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes	8,282,967			Y

International Patents for ZELSUVMI

See the table below for patents covering ZELSUVMI around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112012003792	gel tópico, e, uso do gel tópico.
European Patent Office	2961382	COMPOSITIONS TOPIQUES ET LEURS PROCÉDÉS D'UTILISATION (TOPICAL COMPOSITIONS AND METHODS OF USING THE SAME)
European Patent Office	3166593	COMPOSITIONS ANTIVIRALES TOPIQUES ET MÉTHODES D'UTILISATION DE CELLES-CI (TOPICAL ANTIVIRAL COMPOSITIONS AND METHODS OF USING THE SAME)
European Patent Office	2729131	COMPOSITIONS TOPIQUES (TOPICAL COMPOSITIONS)
European Patent Office	3698775	COMPOSITIONS ANTIVIRALES TOPIQUES ET MÉTHODES D'UTILISATION (TOPICAL ANTIVIRAL COMPOSITIONS AND METHODS OF USING THE SAME)
Japan	7507204
Spain	2731298

Market Dynamics and Financial Trajectory for ZELSUVMI

Introduction to ZELSUVMI

ZELSUVMI (berdazimer) topical gel, 10.3%, is a groundbreaking pharmaceutical product developed for the treatment of molluscum contagiosum (MC), a highly contagious viral skin infection. It has been approved by the U.S. Food and Drug Administration (FDA) and is the first and only topical prescription medication that can be applied at home, outside of a physician’s office or other medical setting[1][3][4].

Market Need and Unmet Medical Needs

Molluscum contagiosum is a common skin infection, particularly among children, but it also affects adults. The current treatment options often involve surgical removal or more intensive therapies, which can be painful and may leave scars. ZELSUVMI addresses this unmet need by providing a non-invasive, topical treatment that can be applied easily at home[1][3][4].

Clinical Trials and Efficacy

The FDA approval of ZELSUVMI was based on evidence from three clinical trials (NI-MC301, NI-MC302, and NI-MC304) involving 1,598 patients. These trials demonstrated significant efficacy, with complete clearance rates of 30.0% to 32.4% in the ZELSUVMI groups compared to 19.7% to 20.3% in the vehicle groups at Week 12[4].

Commercialization Strategy

Ligand Pharmaceuticals, the parent company of Pelthos Therapeutics, has a strategic approach to commercializing ZELSUVMI. This involves partnering with capital providers and/or strategic partners to maximize the value of the product. Ligand has successfully employed this strategy with other companies like Viking Therapeutics, Primrose Bio, and OmniAb®[1][3].

Launch and Availability

ZELSUVMI is expected to be commercially available in the United States in late 2024. Pelthos Therapeutics, a wholly owned subsidiary of Ligand, is leading the commercialization efforts under the leadership of CEO Scott Plesha[1][3].

Financial Projections and Revenue Streams

Ligand's financial trajectory is closely tied to the success of its portfolio, including ZELSUVMI. Here are some key financial points:

• Royalty Revenue Growth: Ligand anticipates significant royalty revenue growth, with ZELSUVMI expected to contribute to this growth starting in 2025. The company projects a 20% Compound Annual Growth Rate (CAGR) in royalty revenue, driven by products like ZELSUVMI, Tzield, Soticlestat, and others[2].
• Current Financial Performance: In the first quarter of 2024, Ligand reported $19.1 million in royalty revenue, with total revenues of $31 million. The company's adjusted EPS for the first quarter was $1.20, and full-year guidance for 2024 is set at $4.25 to $4.75 per diluted share[2].
• Market Size and Potential: While the exact market size for ZELSUVMI is not yet fully determined, the product's unique positioning and the prevalence of molluscum contagiosum suggest a significant market potential. However, the actual market size may vary based on factors such as coverage and reimbursement levels, market acceptance by healthcare providers, and competition[1][3].

Risks and Uncertainties

The commercial success of ZELSUVMI is not without risks. Key uncertainties include:

• Commercial Launch Timing: There is a risk that the commercial launch may be delayed or may not occur as planned in late 2024[1][3].
• Market Acceptance: The product's success depends on its acceptance by healthcare providers and patients, which can be influenced by various factors including coverage and reimbursement levels[1][3].
• Intellectual Property: Ligand faces risks related to the protection of its intellectual property and patents covering ZELSUVMI, which could be challenged or invalidated[1][3].
• Third-Party Dependencies: The company's dependence on third parties for manufacturing and distribution of ZELSUVMI also poses risks[1][3].

Leadership and Management

The commercialization of ZELSUVMI is being led by Scott Plesha, the CEO of Pelthos Therapeutics. Todd Davis, CEO of Ligand Pharmaceuticals, has expressed confidence in the leadership and the strategic approach to maximizing the value of ZELSUVMI[1][3].

Conclusion

ZELSUVMI represents a significant advancement in the treatment of molluscum contagiosum, offering a non-invasive and effective solution for patients. With its expected commercial launch in late 2024, the product is poised to contribute substantially to Ligand's financial growth. However, the success of ZELSUVMI will depend on various factors, including market acceptance, reimbursement levels, and the ability to navigate potential risks and uncertainties.

Key Takeaways

• First and Only Topical Treatment: ZELSUVMI is the first and only approved topical prescription medication for treating molluscum contagiosum at home.
• Clinical Efficacy: Clinical trials demonstrated significant efficacy with complete clearance rates of 30.0% to 32.4% at Week 12.
• Commercialization Strategy: Ligand is commercializing ZELSUVMI through partnerships with capital providers and strategic partners.
• Financial Projections: ZELSUVMI is expected to contribute to Ligand's royalty revenue growth starting in 2025.
• Risks and Uncertainties: Success is subject to market acceptance, reimbursement levels, intellectual property protection, and third-party dependencies.

FAQs

What is ZELSUVMI used for?

ZELSUVMI is used for the topical treatment of molluscum contagiosum (MC), a highly contagious viral skin infection, in adults and pediatric patients one year of age and older[1][3][4].

When is ZELSUVMI expected to be commercially available?

ZELSUVMI is expected to be commercially available in the United States in late 2024[1][3].

What makes ZELSUVMI unique?

ZELSUVMI is the first and only approved topical prescription medication that can be applied by patients, parents, or caregivers at home, outside of a physician’s office or other medical setting[1][3].

What are the key risks associated with the commercialization of ZELSUVMI?

Key risks include delays in commercial launch, market acceptance by healthcare providers, coverage and reimbursement levels, intellectual property challenges, and dependencies on third parties for manufacturing and distribution[1][3].

How does Ligand plan to commercialize ZELSUVMI?

Ligand plans to commercialize ZELSUVMI through partnerships with capital providers and/or strategic partners, consistent with its strategy to maximize the value of highly differentiated pharmaceutical assets[1][3].