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Last Updated: March 29, 2024

PRALSETINIB - Generic Drug Details


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What are the generic drug 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 Y Y ⤷  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 ⤷  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
Eurasian Patent Organization 038890 ИНГИБИТОРЫ RET (INHIBITORS OF RET) ⤷  Try a Trial
South Korea 20180073689 RET의 저해제 ⤷  Try a Trial
European Patent Office 4292594 INHIBITEURS DE RET (INHIBITORS OF RET) ⤷  Try a Trial
Israel 302209 מעכבים של ret (Inhibitors of ret) ⤷  Try a Trial
China 111423416 RET的抑制剂 (Inhibitors of RET) ⤷  Try a Trial
Canada 3096043 INHIBITEUR DE RET DESTINE A ETRE UTILISE DANS LE TRAITEMENT DU CANCER PRESENTANT UNE ALTERATION DU RET (RET INHIBITOR FOR USE IN TREATING CANCER HAVING A RET ALTERATION) ⤷  Try a Trial
>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.