Pralsetinib - Generic Drug Details
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What are the generic sources for pralsetinib and what is the scope of freedom to operate?
Pralsetinib
is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Pralsetinib has sixty-one patent family members in twenty-nine countries.
One supplier is listed for this compound.
Summary for pralsetinib
International Patents: | 61 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 41 |
Clinical Trials: | 7 |
Patent Applications: | 89 |
What excipients (inactive ingredients) are in pralsetinib? | pralsetinib excipients list |
DailyMed Link: | pralsetinib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for pralsetinib
Generic Entry Date for pralsetinib*:
Constraining patent/regulatory exclusivity:
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 pralsetinib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hoffmann-La Roche | Phase 2 |
Genentech, Inc. | Phase 2 |
Blueprint Medicines Corporation | Phase 2 |
Pharmacology for pralsetinib
Drug Class | Kinase Inhibitor |
Mechanism of Action | Rearranged during Transfection (RET) Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for pralsetinib
US Patents and Regulatory Information for pralsetinib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Genentech Inc | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Genentech Inc | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Genentech Inc | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Genentech Inc | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Genentech Inc | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Genentech Inc | GAVRETO | pralsetinib | CAPSULE;ORAL | 213721-001 | Sep 4, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | 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 |
EU/EMA Drug Approvals for pralsetinib
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Roche Registration GmbH | Gavreto | pralsetinib | EMEA/H/C/005413 Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. |
Authorised | no | no | no | 2021-11-18 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for pralsetinib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2022058976 | RETの阻害剤 | ⤷ Try a Trial |
China | 110891573 | RET抑制剂和MTORC1抑制剂的组合及其用于治疗由异常RET活性介导的癌症的用途 (COMBINATIONS OF RET INHIBITORS AND MTORC1 INHIBITORS AND USES THEREOF FOR THE TREATMENT OF CANCER MEDIATED BY ABERRANT RET ACTIVITY) | ⤷ Try a Trial |
Japan | 2018535967 | RETの阻害剤 | ⤷ Try a Trial |
Finland | 3371171 | ⤷ Try a Trial | |
Japan | 2021520349 | RET変化を有する癌の処置において使用するためのRET阻害剤 | ⤷ Try a Trial |
Peru | 20210096 | INHIBIDOR DE RET PARA USO EN TRATAR CANCER QUE TIENE UNA ALTERACION DE RET | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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