Pralsetinib - Generic Drug Details
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What are the generic sources for pralsetinib and what is the scope of patent protection?
Pralsetinib
is the generic ingredient in one branded drug marketed by Blueprint Medicines 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 seventy-one patent family members in thirty-four countries.
One supplier is listed for this compound.
Summary for pralsetinib
International Patents: | 71 |
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 |
Blueprint Medicines Corporation | Phase 2 |
Genentech, Inc. | Phase 2 |
Pharmacology for pralsetinib
Drug Class | Kinase Inhibitor |
Mechanism of Action | Rearranged during Transfection (RET) Inhibitors |
US Patents and Regulatory Information for pralsetinib
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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2019195471 | ⤷ Try a Trial | |
Chile | 2020002544 | Inhibidor de ret para uso en tratar cáncer que tiene una alteración de ret | ⤷ Try a Trial |
Japan | 2023165937 | 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 (RET INHIBITOR FOR USE IN TREATING CANCER HAVING RET ALTERATION) | ⤷ Try a Trial |
Taiwan | I787018 | ⤷ Try a Trial | |
European Patent Office | 4292594 | INHIBITEURS DE RET (INHIBITORS OF RET) | ⤷ Try a Trial |
Japan | 2020519672 | RET阻害剤とmTORC1阻害剤との組合せ及び異常なRET活性によって媒介されるがんを処置するためのその使用 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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