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Last Updated: March 28, 2024

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

SponsorPhase
Hoffmann-La RochePhase 2
Genentech, Inc.Phase 2
Blueprint Medicines CorporationPhase 2

See all pralsetinib clinical trials

Pharmacology 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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