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Cresemba · pharmadog
pharmadog › drugs › Cresemba
isavuconazonium sulfate Marketed updated 2mo ago by Astellas Pharma US Inc
Approved
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generic
isavuconazonium sulfate
Patent cliff source: FDA Orange Book first barrier falls
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, 2028 patent US 10206879*PED 1.7y Mar 14, 2028 patent US 10206879*PED 1.7y Mar 14, 2028 patent US 10603280*PED 1.7y Mar 14, 2028 patent US 10603280*PED 1.7y Sep 14, 2027 formulation US 10206879 1.2y Sep 14, 2027 formulation US 10206879 1.2y Sep 14, 2027 formulation US 10603280 1.2y Sep 14, 2027 formulation US 10603280 1.2y Apr 30, 2026 patent US 6812238*PED Apr 30, 2026 patent US 6812238*PED Apr 30, 2026 patent US 6812238*PED Oct 31, 2025 composition US 6812238 Oct 31, 2025 composition US 6812238 Oct 31, 2025 composition US 6812238 FDA exclusivities (26) Jun 8, 2031 PED Pediatric (6mo bonus) 4.9y Jun 8, 2031 PED Pediatric (6mo bonus) 4.9y Jun 8, 2031 PED Pediatric (6mo bonus) 4.9y Dec 8, 2030 ODE-454 Orphan Drug (7y) 4.4y Dec 8, 2030 ODE-458 Orphan Drug (7y) 4.4y Dec 8, 2030 ODE-458 Orphan Drug (7y) 4.4y
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Dec 8, 2030 ODE-454 Orphan Drug (7y) 4.4y
Dec 8, 2030 ODE-453 Orphan Drug (7y) 4.4y
Dec 8, 2030 ODE-459 Orphan Drug (7y) 4.4y
Sep 6, 2027 GAIN GAIN Antibiotic (5y) 1.2y
Sep 6, 2027 GAIN GAIN Antibiotic (5y) 1.2y
Sep 6, 2027 GAIN GAIN Antibiotic (5y) 1.2y
Jun 8, 2027 PED Pediatric (6mo bonus) 336d
Jun 8, 2027 PED Pediatric (6mo bonus) 336d
Jun 8, 2027 PED Pediatric (6mo bonus) 336d
Dec 8, 2026 NPP New Product (3y) 154d
Dec 8, 2026 NPP New Product (3y) 154d
Dec 8, 2026 NPP New Product (3y) 154d
Sep 6, 2022 PED Pediatric (6mo bonus)
Sep 6, 2022 PED Pediatric (6mo bonus)
Sep 6, 2022 PED Pediatric (6mo bonus)
Mar 6, 2022 ODE* ODE*
Mar 6, 2022 ODE-90 Orphan Drug (7y)
Mar 6, 2022 ODE-305 Orphan Drug (7y)
Mar 6, 2022 ODE-90 Orphan Drug (7y)
Mar 6, 2022 ODE-305 Orphan Drug (7y)
🐶 often sniffed alongside top 2 Trials studying isavuconazonium sulfate 
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