Olutasidenib Patent Expiration
Olutasidenib is Used for treating acute myeloid leukemia with IDH1 mutation in adult patients. It was first introduced by Rigel Pharmaceuticals Inc
Olutasidenib Patents
Given below is the list of patents protecting Olutasidenib, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Rezlidhia | US11723905 | Solid forms of ((s)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile | Nov 12, 2039 | Rigel Pharms |
| Rezlidhia | US11738018 | Inhibiting mutant isocitrate dehydrogenase 1 (mIDH-1) | Jul 17, 2039 | Rigel Pharms |
| Rezlidhia | US10532047 | Solid forms of ((S)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile | May 16, 2039 | Rigel Pharms |
| Rezlidhia | US10959994 | Solid forms of ((S)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile | May 16, 2039 | Rigel Pharms |
| Rezlidhia | US11013733 | Inhibiting mutant isocitrate dehydrogenase 1 (mlDH-1) | May 16, 2039 | Rigel Pharms |
| Rezlidhia | US11013734 | Treating patients harboring an isocitrate dehydrogenase-1 (IDH-1) mutation | May 16, 2039 | Rigel Pharms |
| Rezlidhia | US11376246 | Inhibiting mutant IDH-1 | May 16, 2039 | Rigel Pharms |
| Rezlidhia | US11497743 | Treating patients harboring an isocitrate dehydrogenase 1 (IDH-1) mutation | May 16, 2039 | Rigel Pharms |
| Rezlidhia | US12053463 | Solid forms of ((s)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile | May 16, 2039 | Rigel Pharms |
| Rezlidhia | US10414752 | Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors | Sep 18, 2035 | Rigel Pharms |
| Rezlidhia | US10550098 | Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors | Sep 18, 2035 | Rigel Pharms |
| Rezlidhia | US11498913 | Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors | Sep 18, 2035 | Rigel Pharms |
| Rezlidhia | US12275715 | Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors | Sep 18, 2035 | Rigel Pharms |
| Rezlidhia | US9834539 | Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors | Sep 18, 2035 | Rigel Pharms |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or
decrease the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that
drug. Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in
the patent process of
the drug which can give an idea of how early a drug's generic could be available. The next
section provides a list
of recent legal activities on Olutasidenib's patents.
Latest Legal Activities on Olutasidenib's Patents
Given below is the list recent legal activities going on the following patents of Olutasidenib.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Jan, 2026 | US11376246 |
| Mail-Petition Decision - Granted | 23 Dec, 2025 | US9834539 |
| Petition Decision - Granted | 22 Dec, 2025 | US9834539 |
| Petition Entered | 11 Dec, 2025 | US9834539 |
| Mail-Petition Decision - Granted | 30 Jun, 2025 | US9834539 |
| Petition Decision - Granted | 27 Jun, 2025 | US9834539 |
| Petition Entered | 24 Jun, 2025 | US9834539 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Jun, 2025 | US9834539 |
| FDA Final Eligibility Letter | 20 May, 2025 | US9834539 |
| Mail-Petition Decision - Dismissed | 12 Mar, 2025 | US9834539 |
Olutasidenib's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Olutasidenib:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia. | M.D. Anderson Cancer Center | NA |
RECRUITING
(Sep 1, 2026)
| PHASE2 |
| A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies | M.D. Anderson Cancer Center | NA |
RECRUITING
(Sep 1, 2026)
| PHASE2 |
| Study of Olutasidenib and Temozolomide in HGG | Rigel Pharmaceuticals | NA |
RECRUITING
(Aug 1, 2026)
| PHASE2 |
| Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia | M.D. Anderson Cancer Center | NA |
ACTIVE NOT RECRUITING
(Aug 1, 2026)
| PHASE1 |
| A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia | Kissei Pharmaceutical Co., Ltd. | NA |
RECRUITING
(May 1, 2026)
| PHASE2 |