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Last Updated: December 10, 2024

Olutasidenib - Generic Drug Details


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What are the generic sources for olutasidenib and what is the scope of patent protection?

Olutasidenib is the generic ingredient in one branded drug marketed by Rigel Pharms and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olutasidenib has one hundred and four patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for olutasidenib
International Patents:104
US Patents:13
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 29
Clinical Trials: 2
Patent Applications: 43
What excipients (inactive ingredients) are in olutasidenib?olutasidenib excipients list
DailyMed Link:olutasidenib at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for olutasidenib
Generic Entry Date for olutasidenib*:
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
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.

Recent Clinical Trials for olutasidenib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Nationwide Children's HospitalPhase 2
Rigel PharmaceuticalsPhase 2
Forma Therapeutics, Inc.Phase 1/Phase 2

See all olutasidenib clinical trials

US Patents and Regulatory Information for olutasidenib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rigel Pharms REZLIDHIA olutasidenib CAPSULE;ORAL 215814-001 Dec 1, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rigel Pharms REZLIDHIA olutasidenib CAPSULE;ORAL 215814-001 Dec 1, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Rigel Pharms REZLIDHIA olutasidenib CAPSULE;ORAL 215814-001 Dec 1, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Rigel Pharms REZLIDHIA olutasidenib CAPSULE;ORAL 215814-001 Dec 1, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 olutasidenib

Country Patent Number Title Estimated Expiration
Chile 2017000658 Derivados de piridin-2(1h)-ona quinolinona como inhibidores de isocitrato deshidrogenasa mutante ⤷  Sign Up
South Africa 201902446 PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS ⤷  Sign Up
Malaysia 197533 PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS ⤷  Sign Up
European Patent Office 3720442 INHIBITION DE L'IDH-1 MUTANTE (INHIBITING MUTANT IDH-1) ⤷  Sign Up
>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.