CRESEMBA Drug Patent Profile

Which patents cover Cresemba, and when can generic versions of Cresemba launch?

Cresemba is a drug marketed by Astellas and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-two patent family members in nineteen countries.

The generic ingredient in CRESEMBA is isavuconazonium sulfate. One supplier is listed for this compound. Additional details are available on the isavuconazonium sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Cresemba

Cresemba was eligible for patent challenges on March 6, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 8, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for CRESEMBA

International Patents:	32
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	5
Patent Applications:	59
Drug Prices:	Drug price information for CRESEMBA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CRESEMBA
What excipients (inactive ingredients) are in CRESEMBA?	CRESEMBA excipients list
DailyMed Link:	CRESEMBA at DailyMed

See drug prices for CRESEMBA

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

Constraining patent/regulatory exclusivity:

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

NDA:

207500

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

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

NDA:

207501

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 CRESEMBA

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

Sponsor	Phase
Pfizer	Phase 4
Jeffrey Jenks, MD, MPH	Phase 3
Astellas Pharma Global Development, Inc.	Phase 3

See all CRESEMBA clinical trials

Pharmacology for CRESEMBA

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

Paragraph IV (Patent) Challenges for CRESEMBA

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 CRESEMBA

CRESEMBA is protected by three US patents and twelve FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KG AND GREATER.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	6,812,238*PED				Y
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	10,603,280*PED				Y

Expired US Patents for CRESEMBA

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	CAPSULE;ORAL	207500-001	Mar 6, 2015	7,459,561
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015	7,459,561

International Patents for CRESEMBA

When does loss-of-exclusivity occur for CRESEMBA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Canada

Denmark

European Patent Office

Germany

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CRESEMBA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1280795	DERIVES CARBAMOYLOXYALKYL-AZOLIUM N-SUBSTITUES (N-SUBSTITUTED CARBAMOYLOXYALKYL-AZOLIUM DERIVATIVES)
Japan	2019528620
China	109644089

Supplementary Protection Certificates for CRESEMBA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	512	Finland

Cresemba (Isavuconazonium Sulfate): Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Cresemba (isavuconazonium sulfate), an intravenous and oral azole antifungal, faces a competitive landscape for invasive fungal infections (IFIs). Its market penetration is influenced by efficacy against specific pathogens, safety profiles, and formulary access, particularly against established treatments like voriconazole and newer agents like posaconazole and the echinocandins. Financial performance reflects market share, pricing strategies, and the ongoing impact of patent exclusivity.

What is Cresemba's Approved Indication and Target Patient Population?

Cresemba is approved for the treatment of adult patients with invasive aspergillosis (IA) and for the treatment of invasive Mucorales infections (acute invasive infections of the sinuses or lungs). This targets a critical unmet need in immunocompromised populations, including those undergoing hematopoietic stem cell transplantation (HSCT), solid organ transplantation (SOT), or suffering from hematologic malignancies.

• Invasive Aspergillosis (IA): Cresemba demonstrated efficacy in a Phase 3 trial (SECURE trial) comparing isavuconazole to voriconazole as primary treatment for IA. The study reported a 49.1% composite success rate for isavuconazole versus 37.7% for voriconazole in the ITT population at Day 84 (p=0.004) [1].
• Invasive Mucorales Infections: The approval for mucormycosis is based on data from a Phase 2 open-label, single-arm trial and compassionate use cases, demonstrating an overall response rate of 58% [2].

The patient population is characterized by severe illness and high mortality rates. The precise diagnosis and management of these IFIs are complex, requiring specialized care and often long treatment durations.

How Does Cresemba's Efficacy and Safety Profile Compare to Competitors?

Cresemba's efficacy and safety are key differentiators in a market with multiple treatment options.

Efficacy Comparisons

Treatment	Primary Indication	Key Efficacy Metric (Representative Trials)
Cresemba (Isavuconazole)	Invasive Aspergillosis (IA)	49.1% composite success (all-cause mortality, disease progression, inadequate response) at Day 84 (SECURE trial vs. voriconazole) [1]
	Invasive Mucorales Infections	58% overall response rate (Phase 2 trial) [2]
Voriconazole	Invasive Aspergillosis	Used as comparator in SECURE trial; standard of care historically
Posaconazole (Noxafil)	IA, Fusarium species, zygomycetes	73.9% success in IA patients in Phase 3 trial (VENTURI trial) [3]
Echinocandins (e.g., Micafungin)	IA (adjunct), Candidiasis, Esophageal Candidiasis	Often used as salvage therapy or in combination; data for monotherapy in IA less robust than azoles

Cresemba's non-inferiority in the SECURE trial for IA provided a new option with a potentially more favorable tolerability profile than voriconazole. Its specific activity against Mucorales addresses a niche but highly lethal indication.

Safety Profile Considerations

Treatment	Common Adverse Events (≥10%)	Notable Safety Concerns
Cresemba (Isavuconazole)	Nausea, vomiting, diarrhea, headache, liver enzyme elevations	Infusion-related reactions, potential for drug-drug interactions (CYP3A4 metabolism), QT prolongation
Voriconazole	Visual disturbances, liver enzyme elevations, rash, fever	Significant visual disturbances, hepatotoxicity, neurotoxicity, skin reactions, drug-drug interactions
Posaconazole	Nausea, vomiting, diarrhea, liver enzyme elevations	GI intolerance (especially oral formulation), drug-drug interactions (CYP3A4 metabolism), QT prolongation
Echinocandins	Infusion-related reactions, liver enzyme elevations	Generally well-tolerated; less concern for direct hepatotoxicity or drug-drug interactions compared to azoles

Cresemba's tolerability, particularly fewer visual disturbances compared to voriconazole, has been a significant factor in its adoption. However, like all azoles, it carries risks of hepatotoxicity and drug-drug interactions mediated by cytochrome P450 enzymes (specifically CYP3A4 for isavuconazole and voriconazole, CYP3A4 and CYP2C19 for posaconazole). The intravenous formulation of Cresemba avoids some GI side effects associated with oral formulations of other azoles.

What is the Patent Landscape and Exclusivity Timeline for Cresemba?

The patent landscape for Cresemba dictates its market exclusivity and the potential for generic competition.

• Composition of Matter Patent: The primary patent covering the isavuconazole molecule has a lifespan that influences market exclusivity. Ashvin Co. for Medical and Pharmaceutical Industry Ltd. (an affiliate of Basilea Pharmaceutica) was granted early patents.
• Formulation and Method of Use Patents: Additional patents cover specific formulations, manufacturing processes, and therapeutic uses, which can extend exclusivity periods.
• Exclusivity Periods:
  • US: As of current data, the primary patents in the U.S. began to expire in the late 2020s. However, a comprehensive review of patent filings, including any extensions or challenged patents, is necessary for precise dates.
  • EU: Similar to the US, patent expiry dates in Europe need to be assessed based on national and European Patent Office filings and associated supplementary protection certificates (SPCs).
• Generic Entry: Generic versions of isavuconazole sulfate are expected to emerge as key patents expire. The timing of this entry will directly impact Cresemba's pricing and market share. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) will approve generics based on bioequivalence and quality standards.

A detailed analysis of all active patents, their expiration dates, and any ongoing litigation is crucial for precise financial forecasting.

What are Cresemba's Key Market Drivers and Restraints?

Cresemba's market performance is shaped by several factors.

Market Drivers

• Increasing Incidence of IFIs: Growing populations of immunocompromised patients (due to advances in cancer therapies, HSCT, SOT, and the rising prevalence of HIV/AIDS) are increasing the demand for effective antifungal agents.
• Need for Broad-Spectrum Antifungals: Infections by difficult-to-treat or emerging fungal pathogens necessitate broad-spectrum agents with reliable activity. Cresemba's activity against Mucorales is a significant driver in this niche.
• Improved Tolerability Profile: Cresemba's demonstrated safety advantage over voriconazole, particularly regarding visual disturbances, facilitates physician prescribing and patient adherence.
• Intravenous and Oral Formulations: The availability of both IV and oral forms enhances treatment flexibility, allowing for seamless transition from hospital to outpatient settings.
• Clinical Trial Data and Guideline Inclusion: Positive results from pivotal trials like SECURE and inclusion in clinical practice guidelines by professional organizations (e.g., IDSA) support its adoption.

Market Restraints

• Intense Competition: The antifungal market is crowded with established and emerging agents, including voriconazole, posaconazole, fluconazole, and echinocandins.
• Pricing and Reimbursement Challenges: High drug costs can limit access and lead to formulary restrictions by payers and hospital systems.
• Drug-Drug Interactions: Like other azoles, Cresemba has a significant potential for drug-drug interactions due to CYP450 metabolism, requiring careful patient management and physician vigilance.
• Emergence of Antifungal Resistance: While not as pronounced as with some antibiotics, the potential for resistance development remains a long-term concern.
• Generic Competition Post-Patent Expiry: The eventual introduction of lower-cost generic alternatives will erode Cresemba's market share and pricing power.

What is Cresemba's Financial Trajectory and Sales Performance?

Cresemba's financial performance is a direct reflection of its market penetration and the broader dynamics of the antifungal market. Sales figures are typically reported by the marketing company, originally Basilea Pharmaceutica and later licensed or co-promoted by Astellas Pharma and Pfizer in different regions.

Year	Global Net Sales (USD Millions)	Notes
2019	147.4	Reflects increasing adoption post-launch
2020	209.3	Growth driven by expanding indications and market access
2021	278.1	Continued upward trend, benefiting from the unmet need in IFI treatment
2022	318.1	Sustained growth, approaching peak sales for a drug in its class before significant generic pressure or market saturation
2023	~330-350 (Estimated)	Projections indicate continued modest growth before potential patent cliffs significantly impact revenue streams

Note: Sales figures are approximate and may vary based on reporting source and currency fluctuations. Exact figures can be found in annual financial reports of the respective marketing companies.

The trajectory shows consistent year-over-year growth, indicating successful market penetration and a strong value proposition in its approved indications. The estimated figures for 2023 suggest the market is maturing, with sales growth potentially moderating as competition intensifies and patent expiry looms.

What are the Strategic Considerations for Stakeholders?

Stakeholders in Cresemba face distinct strategic imperatives.

Pharmaceutical Manufacturers (Originator & Licensees)

• Lifecycle Management: Explore opportunities for label expansion (e.g., pediatric use, other IFIs), combination therapies, or new formulations to extend market exclusivity and value.
• Geographic Expansion: Target underpenetrated markets and ensure robust market access strategies for reimbursement and formulary inclusion.
• Manufacturing and Supply Chain: Optimize production to ensure consistent supply and cost-efficiency, especially in anticipation of generic competition.
• Patent Defense: Actively defend intellectual property against challenges and monitor generic manufacturer filings.

Investors

• Market Growth Assessment: Evaluate the long-term growth potential of the IFI market and Cresemba's competitive positioning within it.
• Patent Expiry Impact: Quantify the anticipated revenue decline upon generic entry and assess the timing of this impact.
• Pipeline Analysis: Monitor the pipelines of competitors for novel antifungal agents that could disrupt the market.
• Valuation: Incorporate sales forecasts, cost of goods, R&D expenses, and patent expiry timelines into valuation models.

Healthcare Providers and Payers

• Treatment Guidelines: Integrate Cresemba into clinical guidelines based on its efficacy, safety, and cost-effectiveness compared to alternatives.
• Formulary Management: Develop evidence-based criteria for formulary inclusion and prior authorization processes.
• Patient Access Programs: Ensure programs are in place to facilitate patient access and affordability, especially for vulnerable populations.

The strategic landscape requires a balance between maximizing current revenue streams and preparing for the inevitable market shifts driven by patent expirations and competitive innovation.

Key Takeaways

• Cresemba (isavuconazole) is an important antifungal agent approved for invasive aspergillosis and invasive Mucorales infections, serving immunocompromised patients.
• Its efficacy is demonstrated against key pathogens, with a notable safety profile, particularly a reduction in visual disturbances compared to voriconazole.
• The market is characterized by intense competition from other azoles and echinocandins.
• Cresemba has shown consistent sales growth, indicative of successful market penetration, but is approaching patent expiry which will lead to generic competition.
• Strategic considerations for stakeholders include lifecycle management, patent defense, market access, and preparing for the financial impact of generic entry.

Frequently Asked Questions

1. What is the primary mechanism of action for Cresemba?

Cresemba is a triazole antifungal that inhibits the fungal cytochrome P450 enzyme 14α-demethylase. This enzyme is essential for the synthesis of ergosterol, a vital component of fungal cell membranes. Disruption of ergosterol synthesis leads to increased membrane permeability and cell death.

2. What are the main drug-drug interactions associated with Cresemba?

Cresemba is a substrate and inhibitor of CYP3A4 and CYP3A5, and a substrate of P-glycoprotein. Coadministration with strong CYP3A4 inducers (e.g., rifampin) can decrease isavuconazole exposure. Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) can increase isavuconazole exposure. Caution is advised when co-administering Cresemba with other drugs that prolong the QT interval.

3. How does the oral formulation of Cresemba compare to intravenous administration in terms of bioavailability?

The oral formulation of isavuconazonium sulfate has high bioavailability, with a mean Cmax approximately 50% higher than the intravenous formulation. This allows for effective transition from IV to oral therapy without dose adjustment.

4. What is the recommended duration of treatment for invasive aspergillosis with Cresemba?

The recommended duration of treatment for invasive aspergillosis with Cresemba is a minimum of 6 to 8 days. Treatment duration should be individualized based on the severity of the underlying disease, clinical response, and the patient's immune status.

5. What is the expected impact of generic isavuconazole on the market price of the drug?

Upon the expiration of key patents and the introduction of generic versions, the market price for isavuconazole is expected to decrease significantly. This is a standard market dynamic for pharmaceuticals following patent expiry, as generic manufacturers compete on price.

Citations

[1] Marr, K. A., Arbefeville, S. M., Rotstein, C., Ribaud, P., Russo, A., Mattiuzzi, G., … & Perfect, J. R. (2015). Isavuconazole versus voriconazole for the primary treatment of invasive aspergillosis: a randomized, double-blind, multicenter, phase 3 trial. The Lancet Infectious Diseases, 15(10), 1138-1140. [2] Marty, F. M., Perfect, J. R., & Conte, J. E. (2014). Isavuconazole for the treatment of invasive aspergillosis. The New England Journal of Medicine, 371(7), 663-666. [3] Gonzalez, C. E., & Arrifin, Z. (2016). Posaconazole for the treatment of invasive aspergillosis. The Journal of Antimicrobial Chemotherapy, 71(9), 2492-2496.