drug
hydroxyurea
Marketedupdated 5mo agoby Nova Laboratories Ltd
Approvedcommunity read0 votes
indications
investigational
Sickle Cell Disease
all catalysts(0)
nothing on the calendar yet
Trials studying hydroxyurea
- phase3Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa
- —Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera
- phase3Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
- phase4Evaluation of HU-resistance in Adult Patients With Polycythemia Vera Who Meet PV-AIM Predictors
- —Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
- phase1A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients (South Korea)
- phase1A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients
- phase3Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
Patent cliff
source: FDA Orange Bookfirst barrier falls
Apr 4, 2027
179 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (1)
- Dec 23, 2041formulationUS 12409156
FDA exclusivities (2)
- Apr 4, 2031ODE-470Orphan Drug (7y)4.5y
- Apr 4, 2027NPNP179d
News(2)
- FDA OKs Takeda, Protagonist drug for rare blood cancerThe clearance and broader-than-expected label for Mimrylo open up a yearly revenue opportunity for Takeda that some analysts expect to reach $2 billion or more.biopharma_dive · 1mo ago
- Second Clinical Scenario - Progressive Disease Despite Hematocrit ControlPolycythemia vera symptoms like fatigue and aquagenic itching signal active disease; experts urge objective tracking and tailored therapy beyond phlebotomy.onclive · 4mo ago
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