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
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 ASPERGILLOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KILOGRAMS (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
Astellas Pharma Global Development, Inc.	Phase 3
Jeffrey Jenks, MD, MPH	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	207500-001	Mar 6, 2015		RX	Yes	Yes
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes
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	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 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

International Patents for ISAVUCONAZONIUM SULFATE

Country	Patent Number	Title	Estimated Expiration
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)
Netherlands	300791
Portugal	1280795
Canada	2680292	INTERMEDIAIRES UTILES POUR LA PREPARATION DES DERIVES DE CARBAMOYLOXYALKYL-AZOLIUM SUBSTITUES PAR UN AZOTE (INTERMEDIATES USEFUL FOR THE PREPARATION OF N-SUBSTITUTED CARBAMOYLOXYALKYL-AZOLIUM DERIVATIVES)
European Patent Office	1280795	DERIVES CARBAMOYLOXYALKYL-AZOLIUM N-SUBSTITUES (N-SUBSTITUTED CARBAMOYLOXYALKYL-AZOLIUM DERIVATIVES)
Brazil	PI0015254	compostos derivados de carbamoiloxialquil-azólio, seu uso, bem como composição farmacêutica compreendendo os mesmos.
Luxembourg	92939

Supplementary Protection Certificates for ISAVUCONAZONIUM SULFATE

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	15C0096	France		PRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
1280795	512	Finland
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	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
1280795	122016000011	Germany		PRODUCT NAME: ISAVUCONAZONIUM ALS ISAVUCONAZONIUM-SULFAT ODER ALS SALZ MIT EINEM ANDEREN PHARMAZEUTISCH VERTRAEGLICHEN ANION, SOWIE HYDRATE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/15/1036 20151015
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

ISAVUCONAZONIUM SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Isavuconazonium Sulfate

Introduction

Isavuconazonium sulfate, the prodrug of isavuconazole, is a second-generation triazole antifungal that has gained significant traction in the treatment of invasive aspergillosis and mucormycosis. This article delves into the market dynamics and financial trajectory of isavuconazonium sulfate, highlighting its growth prospects, economic impact, and competitive landscape.

Market Size and Growth Prospects

The global market for isavuconazole, which is administered as isavuconazonium sulfate, has been experiencing robust growth. As of 2023, the market was valued at approximately $63 million and is forecasted to reach $93 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.6% during the forecast period of 2024-2030[4].

Segmentation of the Market

The market for isavuconazonium sulfate is segmented based on several key factors:

By Type

The market is categorized into tablets, powder, and solution forms. Each form has its own set of advantages and is tailored to different patient needs and administration routes[1].

By Application

The primary applications include the treatment of invasive aspergillosis, mucormycosis, and other fungal infections. The drug's broad-spectrum activity and predictable pharmacokinetics make it a preferred choice for these conditions[1][3].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics, influenced by local healthcare systems, regulatory environments, and patient populations[1].

Economic Impact and Cost-Effectiveness

Isavuconazonium sulfate has demonstrated significant economic benefits, particularly when compared to other antifungal agents like voriconazole. A study from the Brazilian supplementary health system (SHS) showed that the incorporation of isavuconazole generates substantial savings. For instance, it was estimated that isavuconazole could save approximately 20.5 million Brazilian Real (BRL) in the first year and up to 54 million BRL by the fifth year, considering a market penetration of 20% in the first year and 50% by the fifth year[2].

Cost-Utility Analysis

The cost-utility analysis revealed that isavuconazole is associated with a saving of 95,174.00 BRL per patient compared to voriconazole. This makes isavuconazole a cost-effective option, especially when considering the willingness to pay for Quality-Adjusted Life Years (QALY)[2].

Competitive Landscape

The market for isavuconazonium sulfate is competitive, with several key players involved:

Major Players

Companies such as Pfizer Inc., Astellas Pharma Inc., Merck & Co. Inc., Teva Pharmaceutical Industries Ltd., and others are prominent in the market. Astellas Pharma Inc. is particularly notable as it markets isavuconazonium sulfate under the brand name Cresemba[1].

Emerging Players

In addition to established players, there are several emerging companies, including Labseeker, Selleck Chemicals, AK Scientific, and others, that are contributing to the market's growth and diversity[4].

Pharmacokinetics and Safety Profile

Isavuconazonium sulfate has a favorable pharmacokinetic profile, characterized by high oral bioavailability, predictable pharmacokinetics, and a good safety profile. It does not require therapeutic drug monitoring and has fewer side effects compared to older azole drugs[3][5].

Formulations

The drug is available in both oral and intravenous formulations, which enhances its versatility and patient compliance. The intravenous formulation avoids the use of cyclodextrin, reducing the risk of nephrotoxicity associated with other antifungals[3].

Market Drivers and Restraints

Drivers

• Increasing Incidence of Fungal Infections: The rising incidence of invasive fungal infections, particularly in immunocompromised patients, drives the demand for effective antifungal agents like isavuconazonium sulfate.
• Advantages Over Competitors: The drug's broad-spectrum activity, predictable pharmacokinetics, and reduced adverse effects make it a preferred choice over other antifungals.
• Economic Benefits: The cost-effectiveness of isavuconazole compared to other treatments is a significant driver, especially for healthcare systems looking to manage costs without compromising patient outcomes[2].

Restraints

• Regulatory Hurdles: Strict regulatory requirements and the need for extensive clinical trials can slow down market entry and expansion.
• Competition: The presence of established antifungal agents and the emergence of new competitors can pose challenges to market growth.
• Geographical Variations: Differences in healthcare systems, reimbursement policies, and patient populations across regions can affect market dynamics[1].

Market Outlook

The market outlook for isavuconazonium sulfate is positive, driven by its robust growth prospects and favorable market dynamics. Here are some key points:

Growth Trends

• The market is expected to continue its upward trend, driven by increasing demand and the drug's advantages over competitors.
• The forecasted CAGR of 5.6% from 2024 to 2030 indicates a steady and significant growth trajectory[4].

Opportunities

• Expanding into New Markets: There is potential for expansion into new geographical regions, particularly in areas with growing healthcare needs and increasing incidence of fungal infections.
• Diversification of Applications: While the primary applications are in treating invasive aspergillosis and mucormycosis, there may be opportunities to explore other fungal infections where isavuconazole could be effective[1].

Challenges

• Maintaining Market Share: With the entry of new competitors, maintaining market share will be a challenge. Companies will need to focus on innovation, pricing strategies, and strong marketing initiatives.
• Regulatory Compliance: Adhering to stringent regulatory requirements and ensuring compliance across different regions will be crucial for sustained growth[1].

Key Takeaways

• Robust Market Growth: The market for isavuconazonium sulfate is expected to grow significantly, driven by its advantages and increasing demand.
• Economic Benefits: Isavuconazole is cost-effective compared to other antifungals, generating substantial savings for healthcare systems.
• Competitive Landscape: The market is competitive, with both established and emerging players contributing to its growth.
• Favorable Pharmacokinetics: The drug's high oral bioavailability, predictable pharmacokinetics, and good safety profile make it a preferred choice.

FAQs

What is the forecasted market size for isavuconazole by 2030?

The global market for isavuconazole is forecasted to reach $93 million by 2030[4].

What are the primary applications of isavuconazonium sulfate?

The primary applications include the treatment of invasive aspergillosis and mucormycosis[1][3].

How does isavuconazole compare to voriconazole in terms of cost-effectiveness?

Isavuconazole is associated with significant savings compared to voriconazole, making it a cost-effective option for treating invasive aspergillosis[2].

What are the key drivers of the isavuconazonium sulfate market?

Key drivers include the increasing incidence of fungal infections, the drug's advantages over competitors, and its economic benefits[1][2].

What are the main challenges facing the isavuconazonium sulfate market?

Challenges include regulatory hurdles, competition from established and emerging players, and geographical variations in healthcare systems and patient populations[1].

Sources

1. Market Research Intellect: "Global Isavuconazonium Sulfate Reagent Sales Market Size, Scope And Forecast 2021-2031"[1].
2. PLOS ONE: "Economic and budgetary impact evaluation of isavuconazole (Cresemba ®) versus voriconazole (Vfend ®) for the treatment of patients with possible invasive aspergillosis from the perspective of the Brazilian supplementary health system"[2].
3. DrugBank Online: "Isavuconazonium sulfate"[3].
4. Valuates Reports: "Isavuconazole - Market Size"[4].
5. PLOS ONE: "Pharmacokinetics of isavuconazonium sulfate and its active metabolite isavuconazole"[5].