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
| 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 | 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 | ||||
| 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 | |||
| >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 |
|---|---|---|---|
| Taiwan | I686390 | ⤷ Sign Up | |
| Moldova, Republic of | 3720442 | ⤷ Sign Up | |
| Hungary | E061331 | ⤷ Sign Up | |
| European Patent Office | 3720442 | INHIBITION DE L'IDH-1 MUTANTE (INHIBITING MUTANT IDH-1) | ⤷ Sign Up |
| Poland | 3720442 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
