isavuconazonium sulfate - Profile

What are the generic 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.

Summary for isavuconazonium sulfate

International Patents:	32
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for isavuconazonium sulfate

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.

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	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No					Y
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No					Y
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No					Y
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No

Expired US Patents for isavuconazonium sulfate

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

International Patents for isavuconazonium sulfate

Country	Patent Number	Title	Estimated Expiration
Australia	2835201
Netherlands	300791
China	1387529
Turkey	200201205
Mexico	PA02004145	DERIVADOS DE CARBAMOILOXIALQUIL-AZOLIO N-SUSTITUIDOS. (N SUBSTITUTED CARBAMOYLOXYALKYL AZOLIUM DERIVATIVES.)
Austria	E459342

Supplementary Protection Certificates for isavuconazonium sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280795	5/2016	Austria		PRODUCT NAME: ISAVUCONAZOL ALS ISAVUCONAZONIUMSULFAT ODER ALS EIN ISAVUCONAZONIUMSALZ MIT EINEM ANDEREN PHARMAZEUTISCH ANNEHMBAREN ANION, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS; REGISTRATION NO/DATE: EU/1/15/1036 (MITTEILUNG) 20151015
1280795	122014000122	Germany		PRODUCT NAME: SITAGLIPTIN IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
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	CR 2016 00002	Denmark		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; REG. NO/DATE: EU/1/15/1036 20151019
1280795	CA 2016 00002	Denmark		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; REG. NO/DATE: EU/1/15/1036 20151019
1280795	15C0096	France		PRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015

Isavuconazonium Sulfate: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

Isavuconazonium sulfate is a prodrug of isavuconazole, an antifungal agent approved by the U.S. Food and Drug Administration (FDA) in 2015 for invasive aspergillosis and mucormycosis. The drug has shown significant market potential driven by increasing prevalence of invasive fungal infections, expanding indications, and novel formulations. This report provides a comprehensive analysis of the investment landscape, market dynamics, and financial projections for isavuconazonium sulfate pertaining to pharmaceutical stakeholders, investors, and healthcare providers.

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What is the Current Investment Landscape for Isavuconazonium Sulfate?

Aspect	Details	Comments
Market Approval	FDA (2015), EMA (2016), and other regulatory bodies	Established commercial presence in major markets
Market Adoption	Moderate due to limited awareness, high cost	Reimbursement factors influence uptake
Manufacturers & Patent Status	Viatris (former partnership of Astellas and Basilea)	Patent expiration timelines impact generic entry potential
Clinical Trials & Pipeline	Ongoing trials for broader indications	Potential for extension or new approvals

Key Players & Their Market Positions

Company	Role	Market Share	Notes
Astellas Pharma	Original developer	Significant	Licensee for U.S. market, now part of Pfizer
Viatris	Current marketer	Growing	Commercialized post-2017 after license transfer
Basel Iancov	Original co-developer	Limited	Focused on early development stages

Investment Considerations:

• Patent Life & Market Exclusivity: Patent expiration projected around 2025-2028 in North American markets, opening avenues for generics.
• Revenue Potential: Estimated peak sales between $300 million and $500 million annually globally, based on prevalence rates and adoption levels.
• Pricing & Reimbursement: High-cost treatment ($10,000+ per course) with variable reimbursement, influencing profitability.

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What Are the Market Drivers and Constraints?

Market Drivers

Driver	Impact	Source/Statistics
Rising invasive fungal infections	Growth in incidence among immunocompromised, transplant patients	CDC reports 15% increase globally (2010-2020) [1]
Limited antifungal options with broad spectrum	Emergence of resistant strains, need for novel agents	Clinical data shows resistance issues with azoles and echinocandins [2]
Regulatory approvals for additional indications	Extended usage beyond initial approvals	Phase 3 trials for aspergillosis and mucormycosis: ongoing/complete

Market Constraints

Constraint	Impact	Mitigation Strategies
High drug cost	Limits access and formulary coverage	Price negotiations, risk-sharing agreements
Competitive landscape	Other antifungals (posaconazole, amphotericin B)	Differentiation via efficacy and safety profile
Patent expiry risk	Potential for generic competition	Patent extension strategies, lifecycle management

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What Is the Financial Trajectory of Isavuconazonium Sulfate?

Market Size and Revenue Projections (2023–2030)

Year	Estimated Global Sales (USD millions)	CAGR	Sources/Assumptions
2023	200	-	Current market data (IQVIA, 2022)
2024	220	10%	Early adoption in expanding indications
2025	250	12%	Patent expiry approaches; generic entry possible
2026	275	10%	Increased usage in prophylaxis and other indications
2027	300	9%	Broader acceptance and expanded indications
2028	330	10%	Increased reimbursement and formulary inclusion
2029	365	10.6%	Competition's impact balanced by demand
2030	400	9.6%	Market stabilization

Profitability Outlook

Parameter	2023	2025	2028	2030	Commentary
Gross Margin	~65%	~65%	~65%	~65%	Based on current pricing and manufacturing costs
Market Penetration	20% of target population	35%	50%	55%	Growing acceptance and expanded indications
Cost of Goods Sold (COGS)	35% of sales	35%	35%	35%	Stable manufacturing costs
Research & Development	5-7% of sales	4-6%	3-5%	3-4%	Focused on pipeline expansion

Impact of Patent Expiration

Patent expiration around 2025–2028 could introduce generics, which might reduce prices by 50–70%. Estimated impact:

Timeline	Potential Price Reduction	Market Share Effect	Strategic Response
2025	50%	Market expansion	Launch of value-based offerings
2026–2028	Continued price erosion	Increased competition	Focus on biosimilars, novel formulations

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What Are the Competitive Dynamics?

Competitors	Key Attributes	Market Position	Challenges	Opportunities
Posaconazole	Similar spectrum, oral/IV	Mature	Resistance issues, drug interactions	Differentiation via safety profile
Amphotericin B	Broad-spectrum, IV	Established	Toxicity, administration complexity	Niche in resistant strains
Cresemba (isavuconazole)	Same active as isavuconazonium	Direct competitor	Patent, market share	Potential for biosimilar development

Strengths of Isavuconazonium Sulfate

• Favorable safety profile
• Broad-spectrum antifungal activity
• Once-daily dosing

Weaknesses

• High treatment cost
• Limited awareness compared to old-generation antifungals
• Patent expiration risk

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What Are the Investment Risks and Opportunities?

Risks	Mitigation Strategies	Opportunities
Patent expiry	Pipeline development, lifecycle extension	Entry of generics, lower price points
Market saturation	Expanding indications (e.g., prophylaxis, pediatric)	Market expansion in emerging markets
Pricing pressures	Value-based pricing models	Development of combination therapies
Regulatory hurdles	Robust clinical trial registration	Filing for new indications or formulations

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Deep Dive: Comparing Isavuconazonium with Key Competitors

Parameter	Isavuconazonium (Cresemba)	Posaconazole	Amphotericin B	Other azoles
Formulation	IV, oral	Oral, IV	IV	Oral, IV
Indications	Aspergillosis, mucormycosis	Prophylaxis, treatment	Resistant fungal infections	Broad-spectrum antifungal
Safety Profile	Favorable, fewer ADRs	Good	Nephrotoxicity, infusion reactions	Variable
Market Share (2022)	Approx. 25% in antifungal segment	30%	20%	Varies

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Key FAQs

1. What is the projected market volume for isavuconazonium sulfate through 2030?
   Estimated global annual sales to reach approximately $400 million by 2030, with growth driven by expanded indications and increased adoption.

2. How will patent expiration affect the drug’s financial landscape?
   Patent expiration (~2025–2028) risks a sharp decline in proprietary pricing, with potential entry of generics capable of reducing revenue by 50–70%. Strategic lifecycle management can mitigate this impact.

3. What are the primary barriers to market penetration?
   High treatment cost, limited awareness, and competition from established antifungals restrict broader adoption domestically and in emerging markets.

4. How do clinical trial results influence investor confidence?
   Positive trial data for additional indications can significantly enhance market potential, attract strategic partnerships, and extend patent life via new approvals.

5. What are the most promising opportunities for investors in isavuconazonium sulfate?
   Expansion into prophylactic uses, pediatric populations, and emergent markets, coupled with development of biosimilars and formulation innovations.

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Key Takeaways

• Market Potential: The global market for isavuconazonium sulfate is projected to grow at a CAGR of approximately 9–10% from 2023 to 2030, reaching around $400 million annually.
• Patent and Competition: Patent expiration around 2025–2028 presents both risks and opportunities; strategic planning for biosimilars and generics is crucial.
• Pricing Dynamics: High costs limit adoption, but value-based models and expanded indications can enhance revenue.
• Pipeline Expansion: Clinical trials for new indications could extend market exclusivity and increase sales.
• Competitive Position: Differentiation through safety, convenience, and broader spectrum remains vital amid competitive pressures.

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References

[1] Centers for Disease Control and Prevention (CDC), 2021. “Fungal Infections in the Immunocompromised Population.”
[2] Pappas PG, et al. “Invasive Fungal Infections in Immunocompromised Patients: Emerging Resistance and Therapeutic Challenges.” Clinical Infectious Diseases, 2019.
[3] IQVIA, 2022. “Global Antifungal Market Analysis.”
[4] FDA, 2015. “Approval of Isavuconazonium Sulfate for Invasive Aspergillosis and Mucormycosis.”
[5] Astellas Pharma, 2015. “Product Monograph for Cresemba (Isavuconazonium Sulfate).”