Last Updated: September 29, 2026

Details for Patent: 12,138,351


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Which drugs does patent 12,138,351 protect, and when does it expire?

Patent 12,138,351 protects LAZCLUZE and is included in one NDA.

This patent has eighteen patent family members in fourteen countries.

Summary for Patent: 12,138,351
Title:Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof
Abstract:Provided herein are pharmaceutical compositions for oral administration comprising N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pirimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide or a pharmaceutically acceptable salt, hydrate, or solvate thereof as an active ingredient; and a combination of (i) a cellulose derivative and (ii) a sugar or polyol as diluents. The disclosed compositions are characterized by improved manufacturability, while maintaining the pharmaceutical benefits of minimizing the effect according to changes in pH environment in the stomach, possessing excellent stability, and exhibiting good bioavailability.
Inventor(s):Jacqueline Maximilien, Gopal Rajan
Assignee: Janssen Biotech Inc
Application Number:US17/228,753
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;

Drugs Protected by US Patent 12,138,351

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Janssen Biotech LAZCLUZE lazertinib mesylate TABLET;ORAL 219008-001 Aug 19, 2024 RX Yes No 12,138,351 ⤷  Start Trial Y ⤷  Start Trial
Janssen Biotech LAZCLUZE lazertinib mesylate TABLET;ORAL 219008-002 Aug 19, 2024 RX Yes Yes 12,138,351 ⤷  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 12,138,351

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 121828 ⤷  Start Trial
Australia 2021257662 ⤷  Start Trial
Australia 2025203347 ⤷  Start Trial
Brazil 112022020609 ⤷  Start Trial
Canada 3180184 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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