Is there a generic for Isavuconazonium sulfate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Isavuconazonium sulfate. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Isavuconazonium sulfate?

CRESEMBA (NDA 207500, ASTELLAS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Isavuconazonium sulfate?

The Orange Book lists 6 patents against Isavuconazonium sulfate products, with the earliest listed expiry in 2025. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Isavuconazonium sulfate have FDA marketing exclusivity?

Yes. The Orange Book records 33 marketing-exclusivity periods for Isavuconazonium sulfate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Isavuconazonium sulfate are approved?

Isavuconazonium sulfate is approved in the following dosage forms: capsule, powder.

FDA Orange Book · active-ingredient family

Isavuconazonium sulfate

Isavuconazonium sulfate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:CRESEMBA · NDA 207500

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, powder

Product	Applicant	Application	TE	Approved
CRESEMBARLD×2	ASTELLAS	NDA 207500	—	Nov 22, 2022
CRESEMBARLD	ASTELLAS	NDA 207501	—	Mar 06, 2015

Marketing exclusivity (33)

NPPNew patient population exclusivity (3 years)
Dec 08, 2026
in 6 mo
ODE*FDA marketing exclusivity
Mar 06, 2022
4 yr 4 mo ago
ODE-454Orphan-drug exclusivity (7 years)
Dec 08, 2030
in 4 yr 6 mo
ODE-458Orphan-drug exclusivity (7 years)
Dec 08, 2030
in 4 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Jun 08, 2031
in 5 yr 1 mo
PEDPediatric exclusivity (adds 6 months)
Jun 08, 2027
in 1 yr
PEDPediatric exclusivity (adds 6 months)
Sep 06, 2022
3 yr 10 mo ago
PEDPediatric exclusivity (adds 6 months)
Jun 08, 2031
in 5 yr 1 mo
GAINQualified infectious disease product exclusivity (adds 5 years)
Sep 06, 2027
in 1 yr 3 mo
NPPNew patient population exclusivity (3 years)
Dec 08, 2026
in 6 mo
ODE-305Orphan-drug exclusivity (7 years)
Mar 06, 2022
4 yr 4 mo ago
ODE-454Orphan-drug exclusivity (7 years)
Dec 08, 2030
in 4 yr 6 mo
ODE-458Orphan-drug exclusivity (7 years)
Dec 08, 2030
in 4 yr 6 mo
ODE-90Orphan-drug exclusivity (7 years)
Mar 06, 2022
4 yr 4 mo ago
PEDPediatric exclusivity (adds 6 months)
Sep 06, 2022
3 yr 10 mo ago
PEDPediatric exclusivity (adds 6 months)
Sep 06, 2022
3 yr 10 mo ago
PEDPediatric exclusivity (adds 6 months)
Jun 08, 2031
in 5 yr 1 mo
PEDPediatric exclusivity (adds 6 months)
Jun 08, 2027
in 1 yr
PEDPediatric exclusivity (adds 6 months)
Jun 08, 2031
in 5 yr 1 mo
GAINQualified infectious disease product exclusivity (adds 5 years)
Sep 06, 2027
in 1 yr 3 mo
GAINQualified infectious disease product exclusivity (adds 5 years)
Sep 06, 2027
in 1 yr 3 mo
NPPNew patient population exclusivity (3 years)
Dec 08, 2026
in 6 mo
ODE-305Orphan-drug exclusivity (7 years)
Mar 06, 2022
4 yr 4 mo ago
ODE-453Orphan-drug exclusivity (7 years)
Dec 08, 2030
in 4 yr 6 mo
ODE-459Orphan-drug exclusivity (7 years)
Dec 08, 2030
in 4 yr 6 mo
ODE-90Orphan-drug exclusivity (7 years)
Mar 06, 2022
4 yr 4 mo ago
PEDPediatric exclusivity (adds 6 months)
Sep 06, 2022
3 yr 10 mo ago
PEDPediatric exclusivity (adds 6 months)
Sep 06, 2022
3 yr 10 mo ago
PEDPediatric exclusivity (adds 6 months)
Jun 08, 2031
in 5 yr 1 mo
PEDPediatric exclusivity (adds 6 months)
Jun 08, 2027
in 1 yr
PEDPediatric exclusivity (adds 6 months)
Jun 08, 2031
in 5 yr 1 mo
GAINQualified infectious disease product exclusivity (adds 5 years)
Sep 06, 2027
in 1 yr 3 mo
GAINQualified infectious disease product exclusivity (adds 5 years)
Sep 06, 2027
in 1 yr 3 mo

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
6812238	Oct 31, 2025	8 mo ago	Substance
6812238*PED	Apr 30, 2026	2 mo ago
10603280	Sep 14, 2027	in 1 yr 3 mo	Product
10206879	Sep 14, 2027	in 1 yr 3 mo	Product
10603280*PED	Mar 14, 2028	in 1 yr 9 mo
10206879*PED	Mar 14, 2028	in 1 yr 9 mo

Isavuconazonium sulfate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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