Cresemba - (372 mg/vial ; For Injection)

Generic Name	Isavuconazonium Sulfate	Innovator	Astellas
Dosage	372 mg/vial ; For Injection	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	Less Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	CRESEMBA ® is an azole antifungal indicated for use in the treatment of: • Invasive aspergillosis. • Invasive mucormycosis.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events

Cresemba - (186 mg ; Capsule)

Generic Name	Isavuconazonium Sulfate	Innovator	Astellas
Dosage	186 mg ; Capsule	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	More Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	CRESEMBA ® is an azole antifungal indicated for use in the treatment of: • Invasive aspergillosis. • Invasive mucormycosis.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events

Cresemba - (74.5 mg ; Capsule)

Generic Name	Isavuconazonium Sulfate	Innovator	Astellas
Dosage	74.5 mg ; Capsule	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	More Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	CRESEMBA ® is an azole antifungal indicated for use in the treatment of: • Invasive aspergillosis. • Invasive mucormycosis.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events