Berdazimer sodium - Generic Drug Details

What are the generic drug 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 fifty-nine patent family members in nine countries.

Summary for berdazimer sodium

International Patents:	59
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	2
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
Synteract, Inc.	Phase 3
Novan, Inc.	Phase 3

See all berdazimer sodium clinical trials

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
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
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)
Japan	7507204

Market Dynamics and Financial Trajectory for Berdazimer Sodium

Introduction

Berdazimer sodium, developed by Novan, Inc., is a promising drug candidate for the treatment of molluscum contagiosum, a viral skin infection affecting approximately 6 million people, primarily children. Here, we delve into the market dynamics and financial trajectory of this drug.

Clinical Development and Regulatory Status

Berdazimer sodium, also known as SB-206, is a nitric oxide-releasing anti-viral new chemical entity. It is applied topically as a gel and has been involved in several clinical trials, with seven completed and one ongoing[1][4].

In January 2023, Novan submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for berdazimer gel, 10.3% (SB206), with a potential approval date anticipated in the first quarter of 2024[4].

Market Potential

The market potential for berdazimer sodium is significant, given the lack of FDA-approved prescription treatments for molluscum contagiosum. If approved, it could become the first FDA-approved prescription product for this condition, addressing a substantial unmet medical need[4].

Revenue Projections

According to GlobalData, the revenue for berdazimer sodium is expected to reach an annual total of $266 million by 2033 in the U.S.[1]. This projection is based on the drug's phase transition success rate, remaining R&D costs, and the likelihood of approval and subsequent sales.

Financial Performance of Novan, Inc.

Novan, Inc. has faced financial challenges while developing berdazimer sodium. For the fiscal year ended December 2022, the company reported revenues of $23.7 million, an operating loss of $29.9 million, and a net loss of $31.3 million[1].

In the first quarter of 2023, Novan reported total revenues of $3.166 million, with a significant decline in revenue compared to the previous quarter due to various factors, including a manufacturing delay affecting one of their commercial products, RHOFADE[2].

Funding and Strategic Arrangements

To address short-term cash needs and support the development of berdazimer gel, Novan is aggressively pursuing various funding or strategic arrangements. This includes potential partnerships, collaborations, licensing agreements, grants, and equity or debt financings. The company has previously raised capital through securities offerings and is exploring additional financial advisors to assist in optimal capital sourcing pathways[2][5].

Ligand Pharmaceuticals' Involvement

Ligand Pharmaceuticals has a significant stake in the success of berdazimer sodium through a development funding and royalties agreement with Novan. Ligand is entitled to receive up to $20 million in milestone payments and tiered royalties of 7% to 10% on future worldwide sales of berdazimer gel[4].

Risk-Adjusted Net Present Value (rNPV) Model

GlobalData's risk-adjusted NPV model (rNPV) provides a conservative valuation measure for berdazimer sodium, accounting for the risks associated with clinical development. This model incorporates the drug's phase transition success rate, remaining R&D costs, and the likelihood of approval and sales-related costs[1].

Commercial Preparation

Novan is actively preparing for the potential approval and commercial launch of berdazimer gel. This includes ongoing interactions with the FDA, building excitement among the dermatology community, and preparing for commercial drug substance supply manufacturing[2].

Competitive Landscape

The dermatology market, particularly for treatments of viral skin infections, is competitive. However, berdazimer sodium's unique mechanism of action and potential to be the first FDA-approved treatment for molluscum contagiosum position it favorably in the market.

Challenges and Opportunities

Despite the promising market potential, Novan faces challenges such as securing additional funding to support ongoing development and commercialization efforts. The company's ability to navigate these challenges will be crucial for the successful launch and market penetration of berdazimer sodium[2][5].

Key Takeaways

• Market Potential: Significant, given the lack of FDA-approved treatments for molluscum contagiosum.
• Revenue Projections: Expected to reach $266 million annually by 2033 in the U.S.
• Financial Challenges: Novan, Inc. faces short-term cash needs and operating losses.
• Funding Arrangements: Aggressive pursuit of funding and strategic arrangements.
• Regulatory Status: NDA submitted with potential approval in Q1 2024.
• Commercial Preparation: Active preparation for potential approval and launch.

FAQs

Q: What is berdazimer sodium used for? A: Berdazimer sodium is used for the treatment of molluscum contagiosum, a viral skin infection.

Q: Who is developing berdazimer sodium? A: Berdazimer sodium is being developed by Novan, Inc.

Q: What is the expected revenue for berdazimer sodium by 2033? A: The revenue for berdazimer sodium is expected to reach an annual total of $266 million by 2033 in the U.S.

Q: Has Novan submitted an NDA for berdazimer gel? A: Yes, Novan submitted an NDA to the FDA in January 2023.

Q: What role does Ligand Pharmaceuticals play in the development of berdazimer sodium? A: Ligand Pharmaceuticals is entitled to milestone payments and royalties through a development funding and royalties agreement with Novan.

Cited Sources

1. Pharmaceutical Technology: "Current valuation of NVN Liquidation's Berdazimer Sodium"
2. BioSpace: "Novan Reports First Quarter 2023 Financial Results and Provides Corporate Update"
3. BioSpace: "Ligand's Partner Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum"
4. Annual Reports: "Novan, Inc. 10K 2020"
5. BioSpace: "Novan, Inc. 10K 2020"