Pharsight

1. Nerlynx patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP10779339A	2020-05-21	Cooke, Richard	Patent maintained as amended
EP09791127A	2017-10-06	Hexal AG	Granted and Under Opposition
EP10722215A	2016-08-03	Hexal AG	Revoked

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7399865	PUMA BIOTECH	Protein tyrosine kinase enzyme inhibitors	Dec, 2030 (7 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7982043	PUMA BIOTECH	Protein tyrosine kinase enzyme inhibitors	Oct, 2025 (2 years from now)
US9630946	PUMA BIOTECH	Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof	Oct, 2028 (5 years from now)
US9139558	PUMA BIOTECH	Maleate salts of (E)-N-{4-[3-Chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof	Oct, 2028 (5 years from now)
US10035788	PUMA BIOTECH	Maleate salts of (E)-N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof	Oct, 2028 (5 years from now)
US9265784	PUMA BIOTECH	Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine	Aug, 2029 (5 years from now)
US9211291	PUMA BIOTECH	Treatment regimen utilizing neratinib for breast cancer	Mar, 2030 (6 years from now)
US8790708	PUMA BIOTECH	Coated tablet formulations and uses thereof	Nov, 2030 (7 years from now)
US8518446	PUMA BIOTECH	Coated tablet formulations and uses thereof	Nov, 2030 (7 years from now)
US8669273	PUMA BIOTECH	Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine	Jul, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication (I)	Feb 25, 2023
New Dosing Schedule (D)	Jun 28, 2024

Drugs and Companies using NERATINIB MALEATE ingredient

Market Authorisation Date: 17 July, 2017

Treatment: Extended adjuvant treatment of adult patients with early stage her2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab base therapy; Use in combination with capecitabine, for the tr...

Dosage: TABLET;ORAL