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Last Updated: June 21, 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 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-five patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for pralsetinib
International Patents:75
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
Blueprint Medicines GAVRETO pralsetinib CAPSULE;ORAL 213721-001 Sep 4, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Blueprint Medicines GAVRETO pralsetinib CAPSULE;ORAL 213721-001 Sep 4, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Blueprint Medicines GAVRETO pralsetinib CAPSULE;ORAL 213721-001 Sep 4, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Blueprint Medicines GAVRETO pralsetinib CAPSULE;ORAL 213721-001 Sep 4, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Blueprint Medicines GAVRETO pralsetinib CAPSULE;ORAL 213721-001 Sep 4, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Blueprint Medicines GAVRETO pralsetinib CAPSULE;ORAL 213721-001 Sep 4, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
European Patent Office 4331585 INHIBITEURS DE RET (INHIBITORS OF RET) ⤷  Sign Up
Poland 3773589 ⤷  Sign Up
China 108473468 RET的抑制剂 (INHIBITORS OF RET) ⤷  Sign Up
Eurasian Patent Organization 201891087 ИНГИБИТОРЫ RET ⤷  Sign Up
Japan 7026196 ⤷  Sign Up
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) ⤷  Sign Up
Lithuania 3773589 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.