Last Updated: November 14, 2026

Details for Patent: 12,692,251

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Which drugs does patent 12,692,251 protect, and when does it expire?

Patent 12,692,251 protects GAVRETO and is included in one NDA.

This patent has fourteen patent family members in fourteen countries.

Summary for Patent: 12,692,251
Title:Pralsetinib pharmaceutical compositions
Abstract:The present disclosure relates to pharmaceutical composition comprising 1) an amorphous solid dispersion comprising pralsetinib, or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable hydrophilic polymer; and 2) an effervescent couple; and crystalline forms of pralsetinib and pralsetinib hydrochloride salt, which are useful as a RET selective inhibitors. The present disclosure also provides pharmaceutically acceptable compositions comprising the crystalline forms and methods of using said compositions in the treatment of various disorders.
Inventor(s):Joshua Waetzig, Gordon D. Wilkie, Debra L. Mazaik, Csanad M. Varga, Lia Rogal, Lauren MacEachern, Kimberly Jean Miller, Shellie Rigby-Singleton, Ian A. Barker, Robert J. Harris, Aimee J. Spenceley, Dipak Gordhan
Assignee: Catalent Nottingham Ltd , Rigel Pharmaceuticals Inc
Application Number:US18/000,166
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;

Drugs Protected by US Patent 12,692,251

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Rigel Pharms GAVRETO pralsetinib CAPSULE;ORAL 213721-001 Sep 4, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 12,692,251

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2021281283 ⤷  Start Trial
Brazil 112022024374 ⤷  Start Trial
Canada 3184648 ⤷  Start Trial
Chile 2022003353 ⤷  Start Trial
China 116133646 ⤷  Start Trial
Costa Rica 20220666 ⤷  Start Trial
European Patent Office 4157230 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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