drug
POSACONAZOLE
Marketedupdated 3mo agoby Par Sterile Products LLC
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 8- drugNOXAFIL POWDERMIX KIT122 co-mentions · 62 sources
- drugNOXAFIL122 co-mentions · 62 sources
- tagApproval122 co-mentions · 61 sources
- drugposaconazole DR62 co-mentions · 62 sources
- tagSmall Molecule48 co-mentions · 48 sources
- company$OGNOrganon & Co.1 co-mentions · 1 sources
- companyMerck Sharp & Dohme LLC1 co-mentions · 1 sources
- tagRecall1 co-mentions · 1 sources
Small molecule drug with a maximum clinical stage of Approval (across all indications), with 10 approved and 8 investigational indications.
all catalysts(36)
approval · 36
Nov 25, 2013
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Mar 13, 2014
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Jun 11, 2014
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Nov 13, 2015
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Nov 13, 2015
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Nov 13, 2015
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Nov 13, 2015
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Sep 9, 2016
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Sep 9, 2016
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Jan 4, 2018
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Jan 4, 2018
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Feb 21, 2019
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Feb 21, 2019
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Mar 11, 2019
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Mar 11, 2019
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Sep 16, 2020
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Sep 16, 2020
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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May 31, 2021
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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May 31, 2021
approval
$MRK135.84+0.21%
NOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
May 31, 2021
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Jun 17, 2021
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Jun 17, 2021
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Jan 13, 2022
approval
$MRK135.84+0.21%
NOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Jan 13, 2022
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Jan 13, 2022
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
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Jan 20, 2022
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Jan 20, 2022
approval
$MRK135.84+0.21%
NOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Jan 20, 2022
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Oct 25, 2024
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Oct 25, 2024
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Oct 25, 2024
approval
$MRK135.84+0.21%
NOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Feb 24, 2025
approval
POSACONAZOLE — FDA approval
POSACONAZOLE
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Oct 29, 2025
approval
POSACONAZOLE — FDA approval
POSACONAZOLE
→
Jan 27, 2026
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Jan 27, 2026
approval
$MRK135.84+0.21%
NOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Jan 27, 2026
approval
NOXAFIL (POSACONAZOLE) — FDA approval
POSACONAZOLE
→
Trials studying POSACONAZOLE
- phase2A Study to Evaluate S241656 Alone or in Combination in Participants With Selected Myeloid Malignancies
- phase2Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression
- phase2A Study of BGB-11417 in Participants With Myeloid Malignancies
- phase3Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
- phase2Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
- phase4Posaconazole for the Prevention of Influenza-associated Aspergillosis in Critically Ill Patients
- phase4Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants
- —Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jun 17, 2028
~1.8 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (6)
- Feb 27, 2033formulationUS 9493582
- Jul 4, 2031formulationUS 90237904.9y
- Jun 24, 2031formulationUS 93582974.9y
- Mar 13, 2029formulationUS 101179512.6y
- Mar 13, 2029formulationUS 84100772.6y
- Mar 13, 2029formulationUS 97508222.6y
FDA exclusivities (5)
- Jan 27, 2029NPPNew Product (3y)2.5y
- Jan 27, 2029NPPNew Product (3y)2.5y
- Jan 27, 2029I-984Indication (3y)2.5y
- Jun 17, 2028ODE-355Orphan Drug (7y)1.8y
- Jun 17, 2028ODE-355Orphan Drug (7y)1.8y
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