drug
fedratinib
Marketedupdated 3mo agoby Bristol-Myers Squibb Co
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for 3 indications.
all catalysts(7)
approval · 7
Aug 16, 2019
approval
$BMY65.47-3.17%
INREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approval
fedratinib
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Nov 23, 2021
approval
$BMY65.47-3.17%
INREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approval
fedratinib
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Dec 3, 2021
approval
$BMY65.47-3.17%
INREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approval
fedratinib
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May 15, 2023
approval
$BMY65.47-3.17%
INREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approval
fedratinib
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Jul 30, 2024
approval
$BMY65.47-3.17%
INREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approval
fedratinib
→
May 12, 2025
approval
$BMY65.47-3.17%
INREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approval
fedratinib
→
Mar 18, 2026
approval
$BMY65.47-3.17%
INREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approval
fedratinib
→
Trials studying fedratinib
- phase2Revumenib in Patients With Myelofibrosis
- phase2Fedratinib in Myelodysplastic /Myeloproliferative Neoplasms (MDS/MPNs) and Chronic Neutrophilic Leukemia (CNL)
- phase1Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms
- phase2A Study of Fedratinib in Japanese Subjects With DIPSS (Dynamic International Prognostic Scoring System)- Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
- phase2A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)
- phase3An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib
- phase3A Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib
- —A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
Patent cliff
source: FDA Orange Bookfirst barrier falls
Dec 16, 2026
117 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (5)
- Sep 24, 2039method-of-use (U-3409)US 11400092
- Jun 4, 2032formulationUS 10391094
- Nov 16, 2031compositionUS 7528143
- Jun 30, 2028method-of-use (U-2607)US 81381991.9y
- Dec 16, 2026compositionUS 7825246117d
FDA exclusivities (1)
- Aug 16, 2026ODE-259Orphan Drug (7y)
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