Supplementary Protection Certificates for ISAVUCONAZONIUM SULFATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280795	SPC/GB15/078	United Kingdom	⤷ Start Trial	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	⤷ Start Trial	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	122016000011	Germany	⤷ Start Trial	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	CA 2016 00002	Denmark	⤷ Start Trial	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	5/2016	Austria	⤷ Start Trial	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	300791	Netherlands	⤷ Start Trial	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	15C0096	France	⤷ Start Trial	PRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Last updated: June 29, 2026

Isavuconazonium sulfate (Cresemba) is an antifungal developed for invasive aspergillosis and mucormycosis. In US commercial markets, the product’s financial trajectory is shaped by (1) uptake constrained by prescriber familiarity and hospital formularies, (2) competitive pressure from voriconazole, liposomal amphotericin B, and newer azoles, (3) payer access driven by infection severity and step-therapy rules, and (4) exclusivity-linked generic entry risk that is mostly controlled by Orange Book patent estates around the original NDA and subsequent listed exclusivities.

Core commercial result: Cresemba revenue growth is typically incremental rather than category-disruptive, with sales concentrated in large academic and tertiary-care hospital networks and higher use in settings where clinicians prefer the oral-to-IV bridging option and a better tolerability profile than certain comparators. The medium-term market outlook is defined by competitive switching between amphotericin B formulations and voriconazole, plus biosimilar and generic dynamics that affect comparator classes more than isavuconazole itself.

What is the commercial history of isavuconazonium sulfate (Cresemba) sales since launch?

Featured snippet answer: Cresemba sales have followed a slow-build trajectory driven by hospital formulary adoption and clinician switching within serious fungal infection pathways, with revenue concentrated in US hospital procurement and later scaling outside the US through established hospital networks.

Launch-to-peak dynamics

Adoption curve: Invasive fungal disease is managed in ID/hematology-oncology units with strict ICU protocols. Formularies often add antifungals after internal evidence review and guideline alignment.
Conversion drivers: Clinician adoption tends to track perceived clinical convenience: IV use followed by oral continuation can reduce inpatient transitions and line burden.
Use-case expansion: Growth depends on treating invasive aspergillosis and mucormycosis populations and shifting practice patterns where isavuconazole is positioned as preferred or alternative therapy.

US revenue profile (what moves the number)

Sales trajectory in the US typically correlates with:

Hospital purchasing volumes at large integrated systems (ID pharmacy committees set ordering behavior).
Inpatient vs outpatient bridging: more oral continuation after stabilization raises total treated-days without proportionate IV procurement.
Competitive substitution intensity:
- Voriconazole remains entrenched for many aspergillosis protocols.
- Liposomal amphotericin B is an anchor comparator for mucormycosis.

(Commercial-financial details like quarterly revenue, exact annual figures, and segment reporting are not provided in the supplied record, so only drivers and market mechanics are covered here.)

How do market dynamics for invasive fungal infections affect isavuconazonium sulfate demand?

Featured snippet answer: Demand is driven by the incidence and management of invasive aspergillosis and mucormycosis in immunocompromised patients, with utilization shaped by guideline-based sequencing, ICU protocol design, and payer coverage constraints.

Category demand elasticity

Patient mix: Hematology and transplant patients represent the core demand. Variations in transplant volume, cancer incidence, and prophylaxis patterns shift the number of cases requiring targeted treatment.
Institutional protocols: Major drivers include ICU antifungal pathways, therapeutic drug monitoring practices, and protocol-based switching criteria.
Seasonality: Aspergillosis cases can show seasonal and environmental influences, affecting quarterly ordering for some institutions.

Payer dynamics

Coverage design: In severe infections, payers often allow exceptions, but pre-authorization and step-editing can still delay time-to-therapy.
Drug budget impact: Antifungals sit in high-cost formularies. Systems prioritize total cost of care, including length of stay and monitoring requirements.

What patent landscape protects isavuconazonium sulfate from generic entry, and how does that shape financial trajectory?

Featured snippet answer: The Cresemba commercial ceiling is set by Orange Book-listed NDA and formulation or method-of-use patents that can delay generic competition; the product’s financial trajectory is therefore tied more to litigation outcomes and exclusivity-triggering events than to day-to-day prescribing.

Exclusivity and patent estate mechanism

Cresemba’s protection typically relies on a combination of:

NDA drug substance and drug product patents (compound-related and formulation/process improvements)
Method-of-use patents tied to therapeutic indications
Regulatory exclusivities (data exclusivity and potential pediatric exclusivity if applicable)
Patent enforcement through Paragraph IV challenges if a generic files to carve out or find non-infringement/invalidity

Financial implications

Near-term: With no generic competition at scale, revenue is protected, but pricing pressure can still occur through payer contracting.
Pre-launch threat: When Paragraph IV cases are pending, wholesalers and hospitals often maintain current stock, but contract negotiations can tighten.
Post-expiration: If an initial generic enters, volume share declines can be swift in hospital purchasing unless brand contracting remains favorable.

(Exact patent numbers, expiration dates, and litigation posture are not included in the supplied record, so they are not listed here.)

What Orange Book status does isavuconazonium sulfate have, and which patents are most important?

Featured snippet answer: Cresemba is expected to have Orange Book-listed patents covering the NDA, with enforcement leverage concentrated in patents that claim the marketed dosage form and approved indications.

Which listed items usually matter most

For hospital-administered oncology and ID use, the most commercially relevant protections are:

Formulation and manufacturing patents for the marketed drug product (not just the active ingredient)
Indication or dosing regimen patents that map to approved labeling and common prescribing patterns
Process patents that can constrain “at-risk” manufacturing for an abbreviated application

How does isavuconazonium sulfate compare with voriconazole and amphotericin B on payer and hospital contracting?

Featured snippet answer: Contracting and hospital formulary decisions tend to balance clinical convenience and monitoring burden against acquisition cost, with isavuconazole favored when clinicians weigh tolerability and operational workflow.

Clinical workflow differentiators

Monitoring burden: Voriconazole is associated with therapeutic drug monitoring and interaction management, influencing pharmacist and ICU workflow.
Tolerability and logistics: Amphotericin B formulations carry nephrotoxicity and infusion-related issues that change supportive care and monitoring protocols.
IV-to-oral transition: A bridging pathway supports continuity of therapy, which payers may value if it reduces length of stay.

Budget impact levers

Acquisition cost: Antifungal procurement cost is negotiated at the system level; branded pricing may be offset by formulary placement and preferred status.
Administrative costs: A drug that reduces monitoring, line management, or ICU time can win access even if unit cost is higher.

What generic entry risks exist for isavuconazonium sulfate, and when could volume shifts occur?

Featured snippet answer: Generic risk is tied to patent expiry and the timing of any Paragraph IV settlement or court decision that allows FDA approval of an ANDA.

Generic launch scenario mechanics

A typical hospital purchasing response to authorized generic or non-branded competition includes:

Contract renegotiation with group purchasing organizations
Switch-at-next-fill for eligible patients
Substitution constraints if a competitor lacks IV-to-oral equivalence, stability, or sufficient supply

Biosimilar risk

Isavuconazonium sulfate is chemically synthesized and does not have biosimilar dynamics. Competitive risk is instead dominated by:

Generics in comparator antifungal classes (voriconazole and amphotericin B formulations)
Newer azole strategies and guideline updates

What formulation and dosing patents matter for isavuconazonium sulfate competitive barriers?

Featured snippet answer: Competitive barriers usually hinge on patents covering the marketed dosage forms and production methods, which affect ANDA design-around feasibility and launch timing.

Dosage form issues that can block or slow entry

IV formulation composition and excipient system
Stability and reconstitution parameters
Manufacturing process controls tied to impurity profiles

These IP components tend to determine whether a generic can launch with immediate parity and whether “at-risk” launches face product quality or infringement exposure.

What patent litigation affects isavuconazonium sulfate, including Paragraph IV challenges and settlements?

Featured snippet answer: Cresemba’s litigation posture, if any, would determine the timing of any ANDA approvals and potential “90-day exclusivity” periods for first filers.

Litigation-to-commercial translation

Pro-Brand rulings delay approval and preserve branded volume share.
Settlements with “delayed entry” terms can create a de facto exclusivity extension even after formal patent expiry.
Carve-out designs can limit the labeled indications that a generic may market, preserving some segment revenue for the brand.

(Exact case names, court venues, filing dates, settlement dates, and delays are not present in the supplied record, so no case list is included.)

What is the FDA regulatory status of isavuconazonium sulfate, including approvals and labeling scope?

Featured snippet answer: Isavuconazonium sulfate is FDA-approved for invasive aspergillosis and mucormycosis, with dosing structured for IV induction followed by maintenance and an oral option for continuation.

Label scope effects on revenue

Indication breadth: Wider label coverage improves addressable patient volume.
Dosing convenience: A regimen that is simple for hospital protocolization improves uptake.

How does isavuconazonium sulfate pricing and access vary by US contract and payer channel?

Featured snippet answer: Pricing is primarily determined by hospital group contracting, with access driven by formulary placement, prior authorization policy, and contracting mechanisms tied to high-cost antifungals.

Channel drivers

GPO and ID pharmacy adoption: Systems often negotiate class-level terms rather than single-drug discounts.
Managed care controls: Commercial payers can impose step edits, but inpatient severity often accelerates authorization.
Medicare/Medicaid: Hospital acquisition rules and DRG structures influence net realized pricing.

(Exact net price and contract structures are not included in the supplied record, so only the contracting mechanics are covered.)

Regional market comparison: How do US vs EU dynamics affect isavuconazonium sulfate revenue?

Featured snippet answer: US demand tends to be more sensitive to hospital formulary uptake and contracting in tertiary centers, while EU results often track country-level reimbursement, tendering behavior, and guideline uptake across member states.

EU access mechanics

Reimbursement timelines: National HTA reviews and reimbursement decisions can shift launch speed and uptake.
Tendering: In some EU markets, public or hospital tendering can force price competition earlier than in the US.
Prescriber behavior: ID and transplant centers influence early adoption across multiple European countries.

Key Takeaways

Isavuconazonium sulfate’s financial trajectory is driven by hospital adoption for invasive aspergillosis and mucormycosis, enabled by IV-to-oral continuation and reduced monitoring workflow relative to some comparators.
Competitive dynamics are dominated by voriconazole and liposomal amphotericin B, with payer access influenced by contract placement and severity-driven authorization.
Generic entry risk is governed by the Orange Book patent estate and potential Paragraph IV litigation or settlements; absent generic competition, near-term revenue tends to remain stable but exposed to pricing renegotiations.
EU growth depends on reimbursement and tendering structures that can compress price sooner than in the US.

FAQs

1) What hospitals use isavuconazonium sulfate most frequently?
Large academic medical centers and tertiary transplant/hematology-oncology ICUs, where antifungal protocols and ID pharmacy governance drive rapid protocolized adoption.

2) Does isavuconazonium sulfate face biosimilar competition?
No. It is a small-molecule drug, so competitive risk comes from generic antifungal substitutes, not biosimilars.

3) What comparators most affect Cresemba’s formulary position?
Voriconazole (for aspergillosis protocols) and liposomal amphotericin B (especially for mucormycosis pathways and critically ill infections).

4) How does IV-to-oral bridging affect market uptake?
It supports continuity of therapy and can reduce inpatient resource intensity, strengthening formulary preference in hospitals seeking operational efficiency.

5) What is the main determinant of generic share loss for Cresemba in the US?
The timing and scope of FDA-allowed generic launch relative to Orange Book patents, plus the branded contract terms that determine whether hospitals switch at the first eligible fill.

References

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Database).
FDA. Drug approvals and labels for isavuconazonium sulfate (Cresemba). (FDA label and approval history).
FDA. ANDA regulatory framework (Paragraph IV, 180/180-day and 90-day exclusivity concepts). (Guidance/overview).

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

Sponsor	Phase
Jeffrey Jenks, MD, MPH	Phase 3
Astellas Pharma Global Development, Inc.	Phase 3
Astellas Pharma Global Development, Inc.	Phase 2

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CRESEMBA	Capsules	isavuconazonium sulfate	74.5 mg	207500	2	2024-09-06
CRESEMBA	For Injection	isavuconazonium sulfate	372 mg/vial	207501	2	2024-09-06

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	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes	10,206,879*PED	⤷ Start Trial			Y	⤷ Start Trial
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No	10,603,280*PED	⤷ Start Trial			Y	⤷ Start Trial
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes	6,812,238*PED	⤷ Start Trial			Y	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Country	Patent Number	Title	Estimated Expiration
Austria	E459342		⤷ Start Trial
Australia	2007302320	Active ingredient containing stabilised solid medicinal forms and method for the production thereof	⤷ Start Trial
Canada	2663941	FORMES GALENIQUES SOLIDES STABILISEES, ET LEUR PROCEDE DE PRODUCTION (STABILIZED SOLID FORMS AND METHOD FOR THE PRODUCTION THEREOF)	⤷ Start Trial
Germany	502007003037		⤷ Start Trial
Denmark	2068842		⤷ Start Trial
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)	⤷ Start Trial
European Patent Office	2068842	FORMES GALÉNIQUES SOLIDES STABILISÉES CONTENANT UN PRINCIPE ACTIF ET DICITRATE DU TRIMAGNÉSIUM COMME DESSICCATEUR ET LEUR PROCÉDÉ DE PRODUCTION (ACTIVE INGREDIENT AND TRIMAGNESIUMDICITRATE AS DESICCANT CONTAINING STABILISED SOLID MEDICINAL FORMS AND METHOD FOR THE PRODUCTION THEREOF)	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Generic Entry Dates for ISAVUCONAZONIUM SULFATE^: ⤷ Start Trial* 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
Generic Entry Dates for ISAVUCONAZONIUM SULFATE^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER Dosage: POWDER;INTRAVENOUS

Summary for ISAVUCONAZONIUM SULFATE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ISAVUCONAZONIUM SULFATE

Recent Clinical Trials for ISAVUCONAZONIUM SULFATE

Pharmacology for ISAVUCONAZONIUM SULFATE

Paragraph IV (Patent) Challenges for ISAVUCONAZONIUM SULFATE