Rezlidhia is a drug owned by Rigel Pharmaceuticals Inc. It is protected by 13 US drug patents filed from 2022 to 2024 out of which none have expired yet. Rezlidhia's patents will be open to challenges from 01 December, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 12, 2039. Details of Rezlidhia's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| 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, 2039
(14 years from now) | Active |
| 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, 2039
(14 years from now) | Active |
| US9834539 | Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors |
Sep, 2035
(10 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| 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, 2039
(14 years from now) | Active |
| US11738018 | Inhibiting mutant isocitrate dehydrogenase 1 (mIDH-1) |
Jul, 2039
(14 years from now) | Active |
| US11013734 | Treating patients harboring an isocitrate dehydrogenase-1 (IDH-1) mutation |
May, 2039
(14 years from now) | Active |
| US11013733 | Inhibiting mutant isocitrate dehydrogenase 1 (mlDH-1) |
May, 2039
(14 years from now) | Active |
| 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, 2039
(14 years from now) | Active |
| US11497743 | Treating patients harboring an isocitrate dehydrogenase 1 (IDH-1) mutation |
May, 2039
(14 years from now) | Active |
| US11376246 | Inhibiting mutant IDH-1 |
May, 2039
(14 years from now) | Active |
| US10414752 | Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors |
Sep, 2035
(10 years from now) | Active |
| US10550098 | Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors |
Sep, 2035
(10 years from now) | Active |
| US11498913 | Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors |
Sep, 2035
(10 years from now) | Active |
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 Rezlidhia's patents.
Latest Legal Activities on Rezlidhia's Patents
Given below is the list of recent legal activities going on the following patents of Rezlidhia.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) Critical | 28 Feb, 2024 | US11013734 |
| Email Notification Critical | 28 Feb, 2024 | US10959994 |
| Change in Power of Attorney (May Include Associate POA) Critical | 28 Feb, 2024 | US10550098 |
| Change in Power of Attorney (May Include Associate POA) Critical | 28 Feb, 2024 | US10959994 |
| Email Notification Critical | 28 Feb, 2024 | US10414752 |
| Email Notification Critical | 28 Feb, 2024 | US10550098 |
| Email Notification Critical | 28 Feb, 2024 | US10532047 |
| Change in Power of Attorney (May Include Associate POA) Critical | 28 Feb, 2024 | US10414752 |
| Change in Power of Attorney (May Include Associate POA) Critical | 28 Feb, 2024 | US10532047 |
| Email Notification Critical | 28 Feb, 2024 | US11013734 |
FDA has granted several exclusivities to Rezlidhia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rezlidhia, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Rezlidhia.
Exclusivity Information
Rezlidhia holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Rezlidhia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 01, 2027 |
| Orphan Drug Exclusivity(ODE-413) | Dec 01, 2029 |
US patents provide insights into the exclusivity only within the United States, but Rezlidhia is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Rezlidhia's family patents as well as insights into ongoing legal events on those patents.
Rezlidhia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rezlidhia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 12, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rezlidhia Generics:
There are no approved generic versions for Rezlidhia as of now.
About Rezlidhia
Rezlidhia is a drug owned by Rigel Pharmaceuticals Inc. It is used for treating acute myeloid leukemia with IDH1 mutation in adult patients. Rezlidhia uses Olutasidenib as an active ingredient. Rezlidhia was launched by Rigel Pharms in 2022.
Approval Date:
Rezlidhia was approved by FDA for market use on 01 December, 2022.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Rezlidhia is 01 December, 2022, its NCE-1 date is estimated to be 01 December, 2026.
Active Ingredient:
Rezlidhia uses Olutasidenib as the active ingredient. Check out other Drugs and Companies using Olutasidenib ingredient
Treatment:
Rezlidhia is used for treating acute myeloid leukemia with IDH1 mutation in adult patients.
Dosage:
Rezlidhia is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | CAPSULE | Prescription | ORAL |