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Last Updated: October 27, 2020

DrugPatentWatch Database Preview

Details for Patent: 8,518,446

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Which drugs does patent 8,518,446 protect, and when does it expire?

Patent 8,518,446 protects NERLYNX and is included in one NDA.

This patent has twenty-five patent family members in eighteen countries.

Summary for Patent: 8,518,446
Title:Coated tablet formulations and uses thereof
Abstract: The present invention provides coated tablet formulations comprising neratinib maleate, and improved methods for making such coated tablets.
Inventor(s): Ashraf; Muhammad (Elmwood, NJ), Mahmud; Mainuddin (Oak Ridge, NJ), Goolcharran; Chimanlall (East Lyme, CT), Ghosh; Krishnendu (Sparkill, NY), Nagi; Arwinder Singh (Moorpark, CA)
Assignee: Wyeth LLC (Madison, NJ)
Application Number:12/940,808
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Process; Dosage form;

Drugs Protected by US Patent 8,518,446

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes   Start Trial   Start Trial Y EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY   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 8,518,446

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 078952   Start Trial
Argentina 114143   Start Trial
Australia 2010316683   Start Trial
Canada 2780428   Start Trial
China 102724970   Start Trial
China 103893140   Start Trial
Denmark 2498756   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Baxter
Colorcon
Harvard Business School
Johnson and Johnson
McKinsey

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