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Last Updated: November 26, 2022

Details for Patent: 8,518,446


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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 See Plans and Pricing See Plans and Pricing Y EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY See Plans and Pricing
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY-STAGE HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-POSITIVE BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASED THERAPY See Plans and Pricing
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y USE IN COMBINATION WITH CAPECITABINE, FOR THE TREATMENT OF ADULT PATIENTS WITH ADVANCED OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR ANTI-HER2 BASED REGIMENS IN THE METASTATIC SETTING See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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