Olutasidenib - Generic Drug Details
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What are the generic drug sources for olutasidenib and what is the scope of freedom to operate?
Olutasidenib
is the generic ingredient in one branded drug marketed by Rigel Pharms Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Olutasidenib has one hundred and three patent family members in thirty-seven countries.
One supplier is listed for this compound.
Summary for olutasidenib
| International Patents: | 103 |
| US Patents: | 12 |
| 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
| Sponsor | Phase |
|---|---|
| Rigel Pharmaceuticals | Phase 2 |
| Nationwide Children's Hospital | Phase 2 |
| Forma Therapeutics, Inc. | Phase 1/Phase 2 |
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 Inc | REZLIDHIA | olutasidenib | CAPSULE;ORAL | 215814-001 | Dec 1, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rigel Pharms Inc | REZLIDHIA | olutasidenib | CAPSULE;ORAL | 215814-001 | Dec 1, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Rigel Pharms Inc | REZLIDHIA | olutasidenib | CAPSULE;ORAL | 215814-001 | Dec 1, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Rigel Pharms Inc | REZLIDHIA | olutasidenib | CAPSULE;ORAL | 215814-001 | Dec 1, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ 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 |
|---|---|---|---|
| Moldova, Republic of | 3720442 | ⤷ Sign Up | |
| Spain | 2706888 | ⤷ Sign Up | |
| Australia | 2015317322 | Phenyl quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors | ⤷ Sign Up |
| Eurasian Patent Organization | 201790657 | ХИНОЛИНОНОВЫЕ ПРОИЗВОДНЫЕ ПИРИДИН-2(1H)-ОНА КАК ИНГИБИТОРЫ МУТАНТНОЙ ИЗОЦИТРАТДЕГИДРОГЕНАЗЫ | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
