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Rezlidhia · pharmadog

pharmadog
drugs
Rezlidhia

drug

patient view →

olutasidenib

Marketedupdated 2mo ago

by $RIGL RIGEL PHARMACEUTICALS INC

Approved

community read0 votes

all catalysts(0)

nothing on the calendar yet

News(0)

no news has mentioned this drug yet

brand

Rezlidhia

generic

olutasidenib

indication

Refractory Acute Myeloid Leukemia

phase

marketed

Patent cliff

source: FDA Orange Book

first barrier falls

Dec 1, 2027

~1.4 years out

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

patents (14)

Nov 12, 2039formulationUS 11723905
Jul 17, 2039method-of-use (U-3684)US 11738018
May 16, 2039compositionUS 10532047
May 16, 2039formulationUS 10959994
May 16, 2039method-of-use (U-3496)US 11013733
May 16, 2039method-of-use (U-3495)US 11013734
May 16, 2039method-of-use (U-3495)US 11376246
May 16, 2039method-of-use (U-3495)US 11497743
May 16, 2039compositionUS 12053463
Sep 18, 2035formulationUS 10414752
Sep 18, 2035formulationUS 10550098
Sep 18, 2035formulationUS 11498913
Sep 18, 2035compositionUS 12275715
Sep 18, 2035compositionUS 9834539

FDA exclusivities (2)

Dec 1, 2029ODE-413Orphan Drug (7y)3.4y
Dec 1, 2027NCENew Chemical Entity (5y)1.4y

Data sources

ClinicalTrials.gov

last refreshed 1h ago

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Trials studying olutasidenib

phase2A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasmwithdrawn
phase2Study of Olutasidenib and Temozolomide in HGGrecruitingn=60
phase2Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapyrecruitingn=16
phase2Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutationsrecruitingn=68
phase4Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignanciesrecruitingn=16
phase2Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclaxnot yet recruitingn=25
phase2A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.recruitingn=15
phase1Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidationrecruitingn=15

more trials →