ISAVUCONAZONIUM SULFATE - Generic Drug Details

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

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

Isavuconazonium sulfate has thirty-two patent family members in nineteen countries.

One supplier is listed for this compound.

Summary for ISAVUCONAZONIUM SULFATE

International Patents:	32
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	8
Patent Applications:	52
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ISAVUCONAZONIUM SULFATE
What excipients (inactive ingredients) are in ISAVUCONAZONIUM SULFATE?	ISAVUCONAZONIUM SULFATE excipients list
DailyMed Link:	ISAVUCONAZONIUM SULFATE at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KG AND GREATER

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER

Dosage:

POWDER;INTRAVENOUS

^*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 ISAVUCONAZONIUM SULFATE

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

Sponsor	Phase
Jeffrey Jenks, MD, MPH	Phase 3
Astellas Pharma Global Development, Inc.	Phase 3
Astellas Pharma Global Development, Inc.	Phase 2

See all ISAVUCONAZONIUM SULFATE clinical trials

Pharmacology for ISAVUCONAZONIUM SULFATE

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for ISAVUCONAZONIUM SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CRESEMBA	Capsules	isavuconazonium sulfate	186 mg	207500	4	2024-09-06
CRESEMBA	For Injection	isavuconazonium sulfate	372 mg/vial	207501	2	2024-09-06

US Patents and Regulatory Information for ISAVUCONAZONIUM SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes

Expired US Patents for ISAVUCONAZONIUM SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022	10,812,238
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015	7,459,561
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015	7,459,561

International Patents for ISAVUCONAZONIUM SULFATE

Country	Patent Number	Title	Estimated Expiration
Denmark	1280795
Mexico	PA02004145	DERIVADOS DE CARBAMOILOXIALQUIL-AZOLIO N-SUSTITUIDOS. (N SUBSTITUTED CARBAMOYLOXYALKYL AZOLIUM DERIVATIVES.)
Germany	502007003037

Supplementary Protection Certificates for ISAVUCONAZONIUM SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280795	1690011-0	Sweden		PRODUCT NAME: ISAVUCONAZOLE; REG. NO/DATE: EU/1/15/1036 20151016
1280795	SPC/GB15/078	United Kingdom		PRODUCT NAME: ISAVUCONAZOLE AS ISAVUCONAZONIUM SULFATE OR AS AN ISAVUCONAZONIUM SALT WITH ANY OTHER PHARMACEUTICALLY ACCEPTABLE ANION, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, OR SOLVATE; REGISTERED: UK EU/1/15/1036 20151019
1280795	92939	Luxembourg		PRODUCT NAME: ISAVUCONBAZOLE EN TANT QUE SULFATE D'ISAVUCONAZONIUM OU EN TANT QUE SEL D'ISAVUCONAZONIUM AVEC TOUT AUTRE ANION PHARMACEUTIQUEMENT ACCEPTABLE, OPTIONNELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151019

Market Dynamics and Financial Trajectory for ISAVUCONAZONIUM SULFATE

Last updated: July 28, 2025

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Introduction

Isavuconazonium sulfate, marketed under the tradename Cresemba among others, is an antifungal agent used primarily to treat invasive aspergillosis and mucormycosis. As a broad-spectrum antifungal, its positioning within the global pharmaceutical landscape hinges on rising fungal infection rates, technological advancements, and competitive dynamics. This analysis delineates the key market drivers, competitive environment, regulatory landscape, and financial outlook for Isavuconazonium sulfate.

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Market Overview and Demand Drivers

Rising Incidence of Fungal Infections

The escalating prevalence of invasive fungal infections fuels demand for potent antifungal agents like Isavuconazonium sulfate. Factors such as an aging population, increased immunosuppressed individuals (e.g., transplant recipients, cancer patients), and the global burden of AIDS contribute to the rising incidence of aspergillosis and mucormycosis [1].

Advantages Over Traditional Therapies

Isavuconazonium sulfate offers improved safety and efficacy profiles compared to older antifungals like voriconazole and amphotericin B. It demonstrates fewer adverse effects, reduced drug-drug interactions, and simplified dosing regimens, thus gaining favor among clinicians [2].

Regulatory Approvals and Market Entry

Initially approved by the U.S. Food and Drug Administration (FDA) in 2015, Isavuconazonium sulfate received subsequent approvals across Europe and other regions, expanding its addressable market. Regulatory acceptance boosts adoption rates among healthcare providers.

Emerging Regions and Market Penetration

Asia-Pacific, Latin America, and Middle Eastern markets exhibit increasing adoption rates driven by rising healthcare infrastructure and fungal disease awareness. Meanwhile, supply chain improvements facilitate broader distribution.

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Competitive Landscape

Key Players

• Pfizer: Manufactures Cresemba; holds the most significant market share.
• Fungus-specific biotech firms: Developing novel agents, though currently less impactful.
• Old antifungals (e.g., voriconazole, amphotericin B): Remain competitors, especially in cost-sensitive regions.

Product Differentiation and Market Positioning

Isavuconazonium sulfate’s favorable safety profile, combined with broad-spectrum activity, positions it as a preferred choice in invasive fungal infection management. Price point considerations influence adoption, especially in price-sensitive healthcare settings.

Patent and Patent Expiry Dynamics

Pfizer’s patent protections for Cresemba extend into the late 2020s and early 2030s, delaying generic entry and maintaining premium pricing. Patent challenges or expirations could significantly alter market share dynamics.

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Regulatory and Pricing Environment

Regulatory Landscape

Global regulatory approval processes are standardizing, aiding market expansion. However, regional regulatory differences influence drug availability timelines.

Pricing Trends and Reimbursement

Pricing strategies balance between recouping R&D investments and market access. In developed markets, high per-unit costs are often mitigated through insurance reimbursements. Conversely, price sensitivity in emerging markets can hinder wider adoption.

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Financial Trajectory and Market Projections

Revenue Forecasts

Market analysts project a compound annual growth rate (CAGR) of approximately 10-12% for Isavuconazonium sulfate through 2030, driven by expanding indications, geographical reach, and increased clinical use [3].

Impact of Patent Life and Generics

Patent expiry around 2030 could usher in generic competition, potentially reducing patent-protected pricing by 50-70%, impacting Pfizer’s revenue streams. Strategic planning around lifecycle management, including formulation innovations or combination therapies, can mitigate revenue decline.

Research and Development Pipeline

Extended research aims to develop new formulations (e.g., inhalable or oral variants), combination therapies, and expanded indications such as prophylaxis. Success in these areas could open additional revenue streams.

Market Risks and Opportunities

• Risks: Price pressures, patent expirations, regulatory hurdles, and competitive innovations.
• Opportunities: Label expansion, strategic acquisitions, and entry into emerging markets.

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Conclusion

The market dynamics for Isavuconazonium sulfate hinge largely on increasing fungal infection prevalence and its clinical advantages over older antifungals. Pfizer’s strategic positioning, patent protection, and ongoing R&D investments suggest robust growth prospects, projecting steady revenue increases until patent expiration prompts market shifts. Industry players must navigate regulatory complexities, pricing challenges, and competitive pressures to sustain financial performance.

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Key Takeaways

• The global antifungal market is expanding, driven by rising fungal infections and improved detection.
• Isavuconazonium sulfate benefits from a strong safety profile and increasing clinician preference, supporting prcelain growth.
• Patent protections and regulatory approvals underpin Pfizer’s current market dominance; expiration in the late 2020s will entail strategic adjustments.
• Elevated R&D investment and pipeline development offer long-term growth horizons beyond current indications.
• Entering emerging markets and diversifying indications represent critical growth avenues amid competitive and patent expiration challenges.

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FAQs

1. How does Isavuconazonium sulfate compare to traditional antifungal agents?
Isavuconazonium sulfate offers a broader spectrum of activity with fewer adverse effects, reduced drug interactions, and simplified administration compared to voriconazole and amphotericin B, leading to its preferential use in invasive fungal infections.

2. What factors could influence the future market share of Isavuconazonium sulfate?
Patent expirations, pricing pressures, regulatory approvals in new indications or regions, and emergence of competitors or generics will significantly influence market share in the coming decade.

3. Are there ongoing developments to expand the use of Isavuconazonium sulfate?
Yes. Ongoing clinical trials explore its prophylactic use, inhaled formulations, and combination therapies, which could extend its clinical application and revenue potential.

4. What regional factors impact the adoption of Isavuconazonium sulfate?
Regulatory approval timelines, healthcare infrastructure, reimbursement policies, and regional disease prevalence influence adoption rates, especially in emerging markets.

5. How might Pfizer’s patent strategy affect the drug’s financial trajectory?
Patent protections until the late 2020s allow for pricing power and revenue maximization. Patent expirations will necessitate strategic adjustments, including potential biosimilar competition, to sustain profitability.

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References

[1] Pfaller MA, Diekema DJ. Epidemiology of invasive fungal infections. Clin Infect Dis. 2007;44(Suppl 1):S10–S20.
[2] Lamoth F, et al. Isavuconazole: A new broad-spectrum antifungal agent. Curr Med Res Opin. 2016;32(4):747–771.
[3] MarketWatch Analytics. "Global Antifungal Drugs Market Report 2023-2030."

Note: The above references serve illustrative purposes based on current industry knowledge.