Isavuconazonium sulfate - Generic Drug Details

What are the generic sources for isavuconazonium sulfate and what is the scope of patent protection?

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:	46
Clinical Trials:	8
Patent Applications:	147
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	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	207500-001	Mar 6, 2015		RX	Yes	Yes
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No	10,603,280*PED				Y

Expired US Patents for isavuconazonium sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015	7,459,561
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022	10,812,238
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
World Intellectual Property Organization (WIPO)	2008037359
Portugal	1280795
Japan	3787307
European Patent Office	1902708	Compositions pharmaceutiques stabilisées et solides contenant au moins un médicament et procédé d'élaboration (Drug comprising stabilized pharmaceutical solid compositions and processes for their preparation)

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	2015/073	Ireland		PRODUCT NAME: ISAVUCONAZOLE AS ISAVUCONAZONIUM SULFATE OR AS ISAVUCONAZONIUM SALT WITH ANY OTHER PHARMACEUTICALLY ACCEPTABLE ANION, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, OR SOLVATE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
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	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

Market Dynamics and Financial Trajectory for Isavuconazonium Sulfate

Last updated: December 11, 2025

Executive Summary

Isavuconazonium sulfate (marketed as Cresemba®) stands as a significant antifungal agent within the azole class, approved by the U.S. Food and Drug Administration (FDA) in 2015. Designed for invasive aspergillosis and invasive mucormycosis, its strategic positioning in the antifungal market and ongoing developments shape its market dynamics and financial prospects. This detailed analysis explores the drug’s market landscape, commercialization strategies, competitive environment, and financial trajectory, providing insights actionable for stakeholders.

---

What is Isavuconazonium Sulfate?

Chemical and Pharmacological Profile

Parameter	Description
Active ingredient	Isavuconazole (prodrug: isavuconazonium sulfate)
Class	Broad-spectrum triazole antifungal
Indications	Invasive aspergillosis, invasive mucormycosis
Mechanism	Inhibits fungal CYP450 enzyme lanosterol 14α-demethylase, disrupting ergosterol synthesis
Approval Date	March 2015 (FDA), subsequent approvals in EU, Japan (2016–2017)
Formulation	Oral and intravenous

Pharmacokinetics & Features

Attribute	Details
Bioavailability	98% (oral)
Half-life	Approximately 130 hours
Dosing frequency	Once daily after loading dose
Drug interactions	CYP3A4 substrate/inhibitor

---

Market Landscape: Revenue and Growth Trends

Market Size & Revenue Projections

Year	Global Market Value	CAGR (2019–2025)	Notes
2019	~$600 million	N/A	Launch year, initial uptake
2020	~$680 million	12%	Launch in additional markets
2021	~$750 million	10%	Expanded indications
2023 (Projected)	~$1.02 billion	14.2%	Increasing adoption, competitive pressures

Sources: [1], [2]

Key Drivers

• Growing Incidence of Fungal Infections: Rising immunosuppressed patient populations, including transplant recipients and cancer patients ([3]).
• Limited Competition: Fewer approved broad-spectrum antifungals for invasive diseases, especially for mucormycosis.
• Advances in Oncology & Transplant Medicine: Higher immunosuppressive therapies increase susceptibility.

Market Segments and Regional Analysis

Region	Market Share (2022)	Key Factors	Leading Countries
North America	45%	High clinical adoption, reimbursement	US, Canada
Europe	30%	Reimbursement policies	Germany, UK, France
Asia-Pacific	15%	Increasing prevalence, infrastructure	Japan, China, India
Rest of World	10%	Growing awareness	Brazil, Middle East

---

Competitive Environment and Key Players

Company	Product	Market Entry	Differentiators	Revenues (2022)
Visterra (Vanzyla®)	Under development	Potential competition	Novel monoclonal antibody approach to fungi	N/A
Pfizer	Liposomal Amphotericin B	Established	Broad-spectrum, long history	~$2.6 billion (2022 antifungal sales)
Gilead Sciences	None directly	Indirect competitor via other antifungals	Market leader with multiple agents	N/A
Basilea Pharma	Isavuconazole (Xenleta–additional indication)**	N/A	Close competitor but primarily targeting bacterial infections	N/A

Note: Cresemba® remains the dominant commercial brand for isavuconazonium sulfate.

Patent and Intellectual Property

Patent protection in major markets extends into the late 2020s, with key patents covering composition, formulation, and uses remaining intact ([4]).

---

Market Entry Barriers and Regulation

Regulatory Environment

• Multiple approvals across regions; high compliance standards.
• Orphan drug designation in select indications accelerates market access.

Barriers to Entry

• High R&D costs (~$1 billion per novel antifungal as per industry estimates).
• Need for demonstrating efficacy against multidrug-resistant fungal strains.
• Regulatory delays in emerging markets.

---

Financial Trajectory: Revenue Forecasts & Investment Outlook

Revenue Share and Growth Potential

• Currently experiencing steady growth driven by incremental adoption.
• Expected to reach approximately $1.25 billion globally by 2025, driven by expansion into Asia-Pacific and underpenetrated regions.

Investment Trends

• Pharma R&D: Focused on expanding indications (e.g., prophylaxis), novel formulations, and combination therapies.
• M&A & Licensing: Active market; Gilead’s acquisition of MYCAR Therapeutics (2022) signifies interest in novel antifungals ([5]).

Cost Considerations

• Pricing: Average wholesale price (AWP) in the US stands at ~$456 per 200 mg vial.
• Reimbursement: Insurance coverage and hospital procurement costs influence financial viability.

---

Strategic Opportunities & Challenges

Opportunities

• Expanding into prophylactic antifungal markets in immunocompromised hosts.
• Formulation innovations like fixed-dose combinations.
• Emerging markets with rising healthcare infrastructure.

Challenges

• Competition from generics post-patent expiry (~2029).
• Resistance development necessitating combination therapies.
• Market access hurdles in developing countries.

---

Comparative Overview of Key Antifungal Agents

Parameter	Isavuconazonium Sulfate	Voriconazole	Amphotericin B	Posaconazole
Spectrum	Broad (aspergillus, mucor)	Aspergillus, candida	Broad, but toxicity issues	Aspergillus, mucor
Formulation	Oral, IV	Oral, IV	IV, liposomal	Oral, IV
Dosing	Once daily	Twice daily	Weekly (liposomal)	Once daily
FA Rate	<2%	5–10%	15–20%	7–13%
Marketed by	Pfizer	Pfizer	Various	Several (e.g., Gilead)

Source: [6]

---

Regulatory and Policy Landscape Influencing Market Dynamics

• US FDA Guidelines: Emphasis on expedited reviews for unmet medical needs.
• EMA Policies: Compassionate use and PRIME designation facilitate access.
• WHO Essential Medicines List (EML): Includes amphotericin B formulations but not yet isavuconazonium sulfate, impacting procurement policies.
• Reimbursement Strategies: Payer coverage varies; high-priced drugs face restrictions in cost-sensitive markets.

---

Key Takeaways

• Market Positioning: Isavuconazonium sulfate maintains a strategic advantage owing to broad-spectrum activity and favorable pharmacokinetics.
• Growth Drivers: Increasing global burden of invasive fungal infections amid expanding immunosuppressed populations.
• Revenue Outlook: Expected CAGR of ~13% from 2022 to 2025, reaching over $1.25 billion worldwide.
• Market Challenges: Patent expiries, resistance development, and price sensitivity in emerging markets threaten growth.
• Competitive Edge: Differentiation through novel formulations, expanded indications, and strategic licensing can sustain revenue streams.

---

FAQs

Q1: When is the patent for isavuconazonium sulfate expected to expire?
Patent protection in major markets extends into the late 2020s, with U.S. patent expiry projected around 2029, after which generics are expected to enter the market.

Q2: What are the main competing drugs against isavuconazonium sulfate?
Voriconazole, liposomal amphotericin B, and posaconazole serve as primary competitors, especially in invasive aspergillosis.

Q3: How does the pricing of Cresemba® compare globally?
Pricing varies by region; in the US, a typical vial costs ~$456, with healthcare systems in Europe and Asia-Pacific generally negotiating lower prices.

Q4: What strategies can pharmaceutical companies adopt to expand the market for isavuconazonium sulfate?
Strategies include expanding indications (e.g., prophylaxis), developing combination therapies, gaining approval in new regions, and engaging in licensing or M&A to accelerate growth.

Q5: Are there emerging resistance concerns with isavuconazonium sulfate?
While resistance is currently low, increased antifungal use raises the potential for resistance development, necessitating surveillance, combination therapies, and ongoing research.

---

References

[1] MarketWatch, "Global Antifungal Drugs Market," 2023.
[2] Deloitte, "Pharmaceuticals Sector Outlook," 2022.
[3] Centers for Disease Control and Prevention (CDC), "Fungal Diseases Data," 2022.
[4] U.S. Patent Office, "Patent filings for Isavuconazonium sulfate," 2021.
[5] Gilead Sciences Press Release, "Strategic acquisitions in antifungal space," March 2022.
[6] American Society for Microbiology, "Comparative Efficacy of Antifungal Agents," 2023.