REZLIDHIA Drug Patent Profile
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When do Rezlidhia patents expire, and when can generic versions of Rezlidhia launch?
Rezlidhia is a drug marketed by Rigel Pharms Inc and is included in one NDA. There are twelve patents protecting this drug.
This drug has one hundred and three patent family members in thirty-seven countries.
The generic ingredient in REZLIDHIA is olutasidenib. One supplier is listed for this compound. Additional details are available on the olutasidenib profile page.
DrugPatentWatch® Generic Entry Outlook for Rezlidhia
Rezlidhia will be eligible for patent challenges on December 1, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 1, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for REZLIDHIA
| International Patents: | 103 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 29 |
| Patent Applications: | 35 |
| Drug Prices: | Drug price information for REZLIDHIA |
| What excipients (inactive ingredients) are in REZLIDHIA? | REZLIDHIA excipients list |
| DailyMed Link: | REZLIDHIA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for REZLIDHIA
Generic Entry Date for REZLIDHIA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
US Patents and Regulatory Information for REZLIDHIA
REZLIDHIA is protected by twelve US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of REZLIDHIA is ⤷ Try a Trial.
This potential generic entry date is based on TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting REZLIDHIA
Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS ACUTE MYELOID LEUKEMIA (AML)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING ACUTE MYELOID LEUKEMIA (AML) IN PATIENTS WITH AN ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING ACUTE MYELOID LEUKEMIA (AML) IN PATIENTS WITH AN ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING ACUTE MYELOID LEUKEMIA (AML) IN PATIENTS WITH AN ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING AN ADULT PATIENT WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA HAVING A SUSCEPTIBLE IDH1 MUTATION
Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING A CANCER WHERE THE CANCER IS ACUTE MYELOID LEUKEMIA (AML)
FDA Regulatory Exclusivity protecting REZLIDHIA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rigel Pharms Inc | REZLIDHIA | olutasidenib | CAPSULE;ORAL | 215814-001 | Dec 1, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Rigel Pharms Inc | REZLIDHIA | olutasidenib | CAPSULE;ORAL | 215814-001 | Dec 1, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Rigel Pharms Inc | REZLIDHIA | olutasidenib | CAPSULE;ORAL | 215814-001 | Dec 1, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Rigel Pharms Inc | REZLIDHIA | olutasidenib | CAPSULE;ORAL | 215814-001 | Dec 1, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Rigel Pharms Inc | REZLIDHIA | olutasidenib | CAPSULE;ORAL | 215814-001 | Dec 1, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for REZLIDHIA
When does loss-of-exclusivity occur for REZLIDHIA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1976
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 15317322
Estimated Expiration: ⤷ Try a Trial
Patent: 15317327
Estimated Expiration: ⤷ Try a Trial
Patent: 15317329
Estimated Expiration: ⤷ Try a Trial
Patent: 19283765
Estimated Expiration: ⤷ Try a Trial
Patent: 21215141
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2017005238
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 61807
Estimated Expiration: ⤷ Try a Trial
Patent: 61811
Estimated Expiration: ⤷ Try a Trial
Patent: 61817
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 17000658
Estimated Expiration: ⤷ Try a Trial
China
Patent: 7001328
Estimated Expiration: ⤷ Try a Trial
Patent: 1909130
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 17003241
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0182176
Estimated Expiration: ⤷ Try a Trial
Patent: 0200666
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 21149
Estimated Expiration: ⤷ Try a Trial
Patent: 22865
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 94376
Estimated Expiration: ⤷ Try a Trial
Patent: 47050
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 17022933
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 4336
Estimated Expiration: ⤷ Try a Trial
Patent: 8574
Estimated Expiration: ⤷ Try a Trial
Patent: 1790657
Estimated Expiration: ⤷ Try a Trial
Patent: 1992489
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 94375
Estimated Expiration: ⤷ Try a Trial
Patent: 94376
Estimated Expiration: ⤷ Try a Trial
Patent: 01185
Estimated Expiration: ⤷ Try a Trial
Patent: 47050
Estimated Expiration: ⤷ Try a Trial
Patent: 33662
Estimated Expiration: ⤷ Try a Trial
Patent: 57131
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 33662
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 41460
Estimated Expiration: ⤷ Try a Trial
Patent: 62424
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1163
Estimated Expiration: ⤷ Try a Trial
Patent: 2363
Estimated Expiration: ⤷ Try a Trial
Patent: 2608
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 48115
Estimated Expiration: ⤷ Try a Trial
Patent: 51081
Estimated Expiration: ⤷ Try a Trial
Patent: 20836
Estimated Expiration: ⤷ Try a Trial
Patent: 17528487
Estimated Expiration: ⤷ Try a Trial
Patent: 17528489
Estimated Expiration: ⤷ Try a Trial
Patent: 17528491
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 94376
Estimated Expiration: ⤷ Try a Trial
Patent: 47050
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 6250
Estimated Expiration: ⤷ Try a Trial
Patent: 7533
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17003404
Estimated Expiration: ⤷ Try a Trial
Patent: 17003626
Estimated Expiration: ⤷ Try a Trial
Patent: 17003637
Estimated Expiration: ⤷ Try a Trial
Patent: 19013203
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 776
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 481
Estimated Expiration: ⤷ Try a Trial
Patent: 064
Estimated Expiration: ⤷ Try a Trial
Patent: 352
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 0373
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 171056
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 017500517
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 94376
Estimated Expiration: ⤷ Try a Trial
Patent: 47050
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 94376
Estimated Expiration: ⤷ Try a Trial
Patent: 47050
Estimated Expiration: ⤷ Try a Trial
Patent: 33662
Estimated Expiration: ⤷ Try a Trial
Saudi Arabia
Patent: 7381129
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 184
Estimated Expiration: ⤷ Try a Trial
Patent: 140
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201702194S
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 94376
Estimated Expiration: ⤷ Try a Trial
Patent: 47050
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1702127
Estimated Expiration: ⤷ Try a Trial
Patent: 1902446
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2209667
Estimated Expiration: ⤷ Try a Trial
Patent: 170063742
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 04897
Estimated Expiration: ⤷ Try a Trial
Patent: 06525
Estimated Expiration: ⤷ Try a Trial
Patent: 06888
Estimated Expiration: ⤷ Try a Trial
Patent: 90640
Estimated Expiration: ⤷ Try a Trial
Patent: 53347
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 86390
Estimated Expiration: ⤷ Try a Trial
Patent: 1617335
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering REZLIDHIA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Eurasian Patent Organization | 201790657 | ХИНОЛИНОНОВЫЕ ПРОИЗВОДНЫЕ ПИРИДИН-2(1H)-ОНА КАК ИНГИБИТОРЫ МУТАНТНОЙ ИЗОЦИТРАТДЕГИДРОГЕНАЗЫ | ⤷ Try a Trial |
| Taiwan | 201617335 | Pyridin-2(1H)-one quinolinone derivatives as mutant-ISO citrate dehydrogenase inhibitors | ⤷ Try a Trial |
| Morocco | 53352 | DÉRIVÉS DE PYRIDIN-2-(1H)-ONE-QUINOLINONE EN TANT QU'INHIBITEURS D'ISOCITRATE DÉSHYDROGÉNASE | ⤷ Try a Trial |
| Serbia | 64069 | INHIBICIJA MUTIRANOG IDH-1 (INHIBITING MUTANT IDH-1) | ⤷ Try a Trial |
| Japan | 2017528489 | 変異イソクエン酸デヒドロゲナーゼ阻害剤としてのフェニルキノリノン誘導体 | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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