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:	1
Clinical Trials:	5
Patent Applications:	82
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
Astellas Pharma Global Development, Inc.	Phase 3
Jeffrey Jenks, MD, MPH	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 fifteen 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
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes

Expired US Patents for CRESEMBA

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

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
China	1387529
China	116056251
Canada	2388320	DERIVES CARBAMOYLOXYALKYL-AZOLIUM N-SUBSTITUES (N-SUBSTITUTED CARBAMOYLOXYALKYL-AZOLIUM DERIVATIVES)

Supplementary Protection Certificates for CRESEMBA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	15C0096	France		PRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
1280795	300791	Netherlands		PRODUCT NAME: ISAVUCONAZOL ALS ISAVUCONAZONIUM SULFAAT OF ALS EEN ISAVUCONAZONIUM ZOUT MET ELK ANDER FARMACEUTISCH AANVAARDBAAR ANION, NAAR KEUZE IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/15/1036 20151019

Market Dynamics and Financial Trajectory for CRESEMBA (Isavuconazole)

Last updated: September 23, 2025

---

Introduction

CRESEMBA (isavuconazole) stands as a significant antifungal agent in the global pharmaceutical landscape. Approved by the FDA in 2015 and later by the EMA in 2016, CRESEMBA has cemented its role in treating invasive fungal infections, notably invasive aspergillosis and mucormycosis. Understanding the complex market dynamics and financial trajectory of CRESEMBA requires an analysis of key factors including market demand, competitive landscape, regulatory environment, manufacturing considerations, and emerging medical needs.

---

Market Overview

Global Pharmaceutical Market for Antifungal Agents

The global antifungal drug market is projected to reach USD 10 billion by 2028, growing at a compound annual growth rate (CAGR) of approximately 4.7% [1]. Rising cases of immunocompromised patient populations, such as those with hematologic malignancies, organ transplants, and HIV/AIDS, drive demand. Invasive fungal infections, though relatively rare, carry high morbidity and mortality, compelling significant investment and innovation.

CRESEMBA specifically targets invasive aspergillosis and mucormycosis, conditions with limited therapeutic options. The need for broad-spectrum, effective drugs with improved safety profiles positions CRESEMBA favorably within this segment.

Market Penetration and Geographic Reach

Initially launched in North America and Europe, CRESEMBA's global penetration has expanded through strategic partnerships. The drug's priority indications are within hospital settings, where clinicians seek rapid, effective antifungal therapy. The penetration in emerging markets, notably Asia-Pacific, is ongoing, with solid growth prospects given the expanding healthcare infrastructure and rising patient awareness of invasive fungal diseases [2].

---

Market Drivers

• Rising Incidence of Fungal Infections: An aging population with increased immunosuppression from chemotherapy, organ transplantation, and AIDS boosts incidence rates.
• Limitations of Existing Therapies: Voriconazole and amphotericin B, traditional antifungals, are associated with significant adverse effects and resistance issues. CRESEMBA offers a more tolerable safety profile.
• Regulatory Approvals and Expanding Indications: Beyond invasive aspergillosis and mucormycosis, ongoing clinical trials exploring additional fungal infections can broaden use cases.
• Growth in Hospitalized Patient Numbers: Increased hospitalization rates for complex surgeries and serious illnesses facilitate prescription opportunities for potent antifungal agents like CRESEMBA.

---

Market Challenges

• Pricing and Reimbursement Pressure: As a specialty drug, CRESEMBA's cost poses reimbursement challenges, especially in price-sensitive markets.
• Competitive Landscape: Established antifungal agents such as voriconazole, amphotericin B, and newer agents like ibrexafungerp pose competitive threats.
• Limited Off-Label Use: The drug's relative specificity limits sales channels outside its approved indications, constraining revenue potential.
• Manufacturing Complexity: The production of isavuconazole involves complex synthetic pathways, influencing manufacturing costs and supply chain stability.

---

Financial Trajectory

Sales Performance

Since its launch, CRESEMBA has demonstrated consistent growth. The drug generated approximately USD 240 million globally in 2021, reflecting increased adoption [3]. Key markets include the U.S., Europe, and select Gulf Cooperation Council countries. Year-over-year growth is fueled by expanded indications, drug awareness, and rising refractory fungal infections.

Revenue Forecasts

Analysts project that, over the next five years, CRESEMBA’s revenues could exceed USD 400 million annually, contingent on:

• Expanded approval for additional indications.
• Increased market penetration in Asia-Pacific.
• Adoption in emerging hospital protocols for invasive fungal infections.

The drug’s growth trajectory benefits from patent protections until at least 2030, with potential for lifecycle management strategies, including formulations or combination products.

Pricing Strategy and Reimbursement

Pricing remains a critical driver. With per-dose costs estimated at USD 1,500-$2,000 in the U.S., negotiations with payers dictate market access. Value-based pricing discussions are increasingly prevalent, emphasizing outcomes over volume. Reimbursement hurdles may temper growth but are expected to stabilize as clinical benefits become more widely recognized.

---

Regulatory Environment and Impact on Market

The approval of CRESEMBA in major jurisdictions catalyzed its market entrants. The FDA's Fast Track designation in certain indications accelerated development timelines, facilitating swift reimbursement pathways. Meanwhile, the EMA’s orphan designation granted additional market exclusivities, safeguarding revenue streams.

Emerging global regulatory trends emphasize the approval of antifungals with broad-spectrum activity, safety, and ease of administration, aligning well with CRESEMBA's profile.

---

Emerging Trends Influencing Future Financial Trajectory

• Growing Use in COVID-19-Related Fungal Co-infections: The pandemic has spotlighted invasive fungal infections, especially in immunocompromised, ventilated patients. CRESEMBA’s role could expand via clinical trial data supporting efficacy in these settings.

• Development of Novel Formulations: Intravenous to oral conversion, and potential combination therapies, represent opportunities to offset competitive pressures and bolster revenues.

• Strategic Partnerships and Licensing Agreements: Collaborations with regional pharmaceutical companies can facilitate entry into slower markets, augmenting sales.

• Price Optimization and Cost Management: Companies leveraging data analytics for personalized dosing can improve margins and sensitivity to payer incentives.

---

Conclusion

CRESEMBA's market dynamics hinge on an expanding global need for effective antifungal treatments amid rising fungal infection cases. Its financial trajectory, characterized by steady growth, benefits from ongoing clinical validation, regulatory support, and strategic market expansion. Nonetheless, competitive forces, pricing pressures, and manufacturing considerations remain factors to watch. The drug’s future appears promising, with potential revenue acceleration driven by broader indications and geographical penetration.

---

Key Takeaways

• Market Growth: The antifungal market, especially for invasive infections, is expanding at a CAGR of 4.7%, favoring CRESEMBA’s growth prospects.
• Drivers: Rising immunocompromised populations and limitations of existing therapies are primary growth catalysts.
• Revenue Potential: CRESEMBA could surpass USD 400 million annually in revenue within five years, contingent on market expansion and regulatory approvals.
• Competitive Landscape: Dominance of established antifungals necessitates strategic differentiation and value-based pricing.
• Emerging Trends: COVID-19-related infections and innovation in formulations are poised to influence future sales trajectories.

---

FAQs

1. How does CRESEMBA compare to traditional antifungal agents in terms of efficacy and safety?
CRESEMBA (isavuconazole) demonstrates comparable or superior efficacy in invasive fungal infections with a favorable safety profile, notably fewer hepatic and renal adverse effects compared to agents like voriconazole and amphotericin B.

2. What are the primary markets for CRESEMBA and its growth prospects?
Key markets include North America, Europe, and select Asia-Pacific countries. Its growth prospects are bolstered by expanding indications, increasing hospital admissions, and strategic regional partnerships.

3. What factors influence CRESEMBA’s pricing and reimbursement strategies?
Pricing is affected by manufacturing costs, competitive positioning, and payer negotiations. Reimbursement strategies increasingly focus on demonstrated clinical value to justify premium pricing.

4. Are there upcoming regulatory challenges or approvals that could impact CRESEMBA’s trajectory?
Further approvals for additional indications, expanded age groups, or new formulations could enhance revenue. However, delays or unfavorable regulatory decisions in key markets could restrain growth.

5. How could manufacturing complexity impact CRESEMBA’s future supply and pricing?
Manufacturing complexities elevate production costs and may cause supply constraints, affecting pricing and availability. Investment in scalable, cost-efficient manufacturing remains critical for sustained growth.

---

Sources

[1] MarketsandMarkets. Antifungal Drugs Market Forecast. 2022.
[2] GlobalData. Pharmaceuticals Market Analysis and Trends. 2022.
[3] EvaluatePharma. Annual Report on Antifungal Drugs. 2021.