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  1. pharmadog
  2. ›drugs
  3. ›Cresemba
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isavuconazonium sulfate

Marketedupdated 3mo ago
by Astellas Pharma US Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • companyBasilea Pharmaceutica Ltd1 co-mentions · 1 sources
  • tagInfectious Disease1 co-mentions · 1 sources

all catalysts(1)

patent expiry · 1
Apr 30, 2026
patent expiry
4mo ago
Basilea Pharmaceutica Ltd — isavuconazonium sulfate (Constraining Patent Expiry (US))
isavuconazonium sulfate
→

Trials studying isavuconazonium sulfate

  • phase2A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participantscompletedn=31
  • phase1A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participantscompletedn=17
  • phase1A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patientscompletedn=49
  • —Registry of Patients Treated With Systemic Mold-Active Triazolescompletedn=2,015

Patent cliff

source: FDA Orange Book
first barrier falls
Dec 8, 2026
112 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (14)

  • Mar 14, 2028patentUS 10206879*PED1.6y
  • Mar 14, 2028patentUS 10206879*PED1.6y
  • Mar 14, 2028patentUS 10603280*PED1.6y
  • Mar 14, 2028patentUS 10603280*PED1.6y
  • Sep 14, 2027formulationUS 102068791.1y
  • Sep 14, 2027formulationUS 102068791.1y
  • Sep 14, 2027formulationUS 106032801.1y
  • Sep 14, 2027formulationUS 106032801.1y
  • Apr 30, 2026patentUS 6812238*PED
  • Apr 30, 2026patentUS 6812238*PED
  • Apr 30, 2026patentUS 6812238*PED
  • Oct 31, 2025compositionUS 6812238
  • Oct 31, 2025compositionUS 6812238
  • Oct 31, 2025compositionUS 6812238

FDA exclusivities (26)

  • Jun 8, 2031PEDPediatric (6mo bonus)4.8y
  • Jun 8, 2031PEDPediatric (6mo bonus)4.8y
  • Jun 8, 2031PEDPediatric (6mo bonus)4.8y
  • Dec 8, 2030ODE-454Orphan Drug (7y)4.3y
  • Dec 8, 2030ODE-458Orphan Drug (7y)4.3y
  • Dec 8, 2030ODE-458Orphan Drug (7y)4.3y
  • Dec 8, 2030ODE-454Orphan Drug (7y)4.3y
  • Dec 8, 2030ODE-453Orphan Drug (7y)4.3y
  • Dec 8, 2030ODE-459Orphan Drug (7y)4.3y
  • Sep 6, 2027GAINGAIN Antibiotic (5y)1.1y
  • Sep 6, 2027GAINGAIN Antibiotic (5y)1.1y
  • Sep 6, 2027GAINGAIN Antibiotic (5y)1.1y
  • Jun 8, 2027PEDPediatric (6mo bonus)294d
  • Jun 8, 2027PEDPediatric (6mo bonus)294d
  • Jun 8, 2027PEDPediatric (6mo bonus)294d
  • Dec 8, 2026NPPNew Product (3y)112d
  • Dec 8, 2026NPPNew Product (3y)112d
  • Dec 8, 2026NPPNew Product (3y)112d
  • Sep 6, 2022PEDPediatric (6mo bonus)
  • Sep 6, 2022PEDPediatric (6mo bonus)
  • Sep 6, 2022PEDPediatric (6mo bonus)
  • Mar 6, 2022ODE*ODE*
  • Mar 6, 2022ODE-90Orphan Drug (7y)
  • Mar 6, 2022ODE-305Orphan Drug (7y)
  • Mar 6, 2022ODE-90Orphan Drug (7y)
  • Mar 6, 2022ODE-305Orphan Drug (7y)

News(0)

no news has mentioned this drug yet

brand
Cresemba
generic
isavuconazonium sulfate
indication
Aspergillosis
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 25m ago
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