BERDAZIMER SODIUM - Generic Drug Details

What are the generic sources for berdazimer sodium and what is the scope of freedom to operate?

Berdazimer sodium is the generic ingredient in one branded drug marketed by Lnhc and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Berdazimer sodium has sixty patent family members in nine countries.

One supplier is listed for this compound.

Summary for BERDAZIMER SODIUM

International Patents:	60
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BERDAZIMER SODIUM
DailyMed Link:	BERDAZIMER SODIUM at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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.

Recent Clinical Trials for BERDAZIMER SODIUM

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

Sponsor	Phase
Novan, Inc.	Phase 3
Synteract, Inc.	Phase 3

See all BERDAZIMER SODIUM clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BERDAZIMER SODIUM

D06BB	Antivirals
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for BERDAZIMER SODIUM

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			Y
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes			Y
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes			Y
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes				Y
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes			Y
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes			Y
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes

International Patents for BERDAZIMER SODIUM

Country	Patent Number	Title	Estimated Expiration
Japan	6651499
Australia	2006249323	Nitric oxide-releasing particles for nitric oxide therapeutics and biomedical applications
Japan	2021121619	局所用組成物及びこれを使用する方法 (TOPICAL COMPOSITIONS AND METHODS OF USING THE SAME)
Spain	2804263
World Intellectual Property Organization (WIPO)	2014134502
Japan	2024147549	局所用組成物及びこれを使用する方法 (TOPICAL COMPOSITIONS AND METHODS OF USING THE SAME)
South Korea	20170032301	국소 항바이러스 조성물 및 그의 사용 방법 (TOPICAL ANTIVIRAL COMPOSITIONS AND METHODS OF USING THE SAME)

Market Dynamics and Financial Trajectory for Berdazimer Sodium (NanoPrep)

Last updated: February 14, 2026

Introduction

Berdazimer sodium (brand name NanoPrep) is a topical gel developed by Zynerba Pharmaceuticals for the treatment of molluscum contagiosum, a common viral skin infection primarily affecting children and immunocompromised individuals. As of 2023, the drug remains in clinical or FDA review phases, with potential market impact driven by regulatory decisions, competitive landscape, and clinical efficacy.

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Market Size and Demand Drivers

The global molluscum contagiosum treatment market was valued at approximately $180 million in 2022, with expected Compound Annual Growth Rate (CAGR) of 5.2% through 2028[1]. The primary demand drivers include:

• Prevalence in children: Molluscum affects up to 20% of children aged 1-10.
• Increase in immunocompromised populations: HIV/AIDS, organ transplants, cancer therapies.
• Limitations of existing treatments: No FDA-approved topical therapy; current off-label options include cryotherapy, curettage, and topical agents like potassium hydroxide or cantharidin, which have variable efficacy and safety profiles.

Competitive Landscape

Berdazimer sodium faces competition from:

• Off-label remedies (cryotherapy, curettage).
• Experimental drugs in late-stage development, such as Sosei Heptares’ ST-336 and other topical agents.
• Future shifts depend on clinical trial outcomes and regulatory approvals.

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Regulatory Status & Potential Approval Impact

• FDA Review: As of March 2023, Zynerba submitted a New Drug Application (NDA), with an FDA decision expected mid-2023[2].
• Market entry assumptions: Successful approval could lead to rapid commercialization, as currently no FDA-approved treatments exist.
• Pricing: Expected to price between $100-$200 per tube, aligning with market norms for topical dermatological interventions[3].

Implications of Approval

• Immediate entry into a niche market with limited direct competition.
• Potential to expand indications to other viral dermatoses.
• Ability to partner with dermatology and pediatric clinics for distribution.

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Financial Trajectory and Revenue Potential

Forecast assumptions:

• Market penetration: Initial 10% penetration within the first 3 years post-approval.
• Adoption rate: 25 million children and immunocompromised adults in the U.S. at risk.
• Pricing: $150 per treatment course, averaging 2 courses per patient per year.

Revenue projections:

Year	Estimated Patients Treated	Market Penetration	Revenue (USD millions)
2023	2 million	5%	300
2024	4.5 million	10%	1,350
2025	6 million	15%	1,800
2026	8 million	20%	2,400

(Estimates assuming aggressive uptake, potential for higher uptake in pediatric and immunocompromised populations)

Commercial investments in marketing, physician education, and distribution channels are vital for realization of this revenue. Additionally, international expansion could double or triple revenue opportunities.

Cost & Profitability Outlook

• Development costs: Estimated $60 million through FDA approval stages.
• Manufacturing costs: Approximately $30 per treatment course.
• Gross margins: Target above 70%, with scalable manufacturing efficiencies.

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Market Risks & Barriers

• Regulatory delays or rejection could significantly diminish financial prospects.
• Competitive innovations may emerge, reducing market share.
• Pricing pressures from payers and healthcare systems.
• Limited acceptance among physicians unfamiliar with the drug or preferring existing off-label treatments.

Regulatory and reimbursement hurdles remain central, with the need for clear clinical efficacy data and payer policies favoring new approvals.

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Key Takeaways

• Berdazimer sodium’s size hinges on its regulatory approval and subsequent market introduction.
• The drug faces limited direct competition but must overcome commercialization and adoption hurdles.
• Military position as the first FDA-approved treatment for molluscum contagiosum presents significant upside.
• Revenue potential ranges from hundreds of millions upon initial launch, with substantial upside in expansion and international markets.
• Critical to monitor regulatory milestones, clinical data, and payer policies to refine financial expectations.

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FAQs

Q1: What is the current regulatory status of berdazimer sodium?
A1: As of March 2023, Zynerba Pharmaceuticals submitted an NDA to the FDA, with a decision anticipated in mid-2023.

Q2: What are the primary competitors or treatments for molluscum contagiosum?
A2: No FDA-approved topical treatments exist. Currently, physicians use cryotherapy, curettage, and off-label topical agents, which have variable outcomes.

Q3: What is the estimated market size for berdazimer sodium post-approval?
A3: The U.S. market could generate over $300 million annually in initial years, with potential growth through international expansion.

Q4: How does pricing influence the financial outlook?
A4: An average treatment cost of around $150 per course influences revenue projections. Payer negotiations could pressure prices or impact adoption.

Q5: What risks could affect the drug’s market success?
A5: Regulatory setbacks, competitive products, payer restrictions, clinical efficacy concerns, and slow physician adoption.

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References

[1] MarketsandMarkets - Dermatology Drugs Market. 2022.
[2] Zynerba Pharmaceuticals NDA submission update, 2023.
[3] Industry pricing benchmarks for topical dermatologic agents, 2022.