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Last Updated: December 3, 2023

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 Genentech Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pralsetinib has fifty-three patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for pralsetinib
International Patents:53
US Patents:2
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:

*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

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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson

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.