List of Nerlynx drug patents

Nerlynx is owned by Puma Biotech.

Nerlynx contains Neratinib Maleate.

Nerlynx has a total of 10 drug patents out of which 0 drug patents have expired.

Nerlynx was authorised for market use on 17 July, 2017.

Nerlynx is available in tablet;oral dosage forms.

Nerlynx can be used as 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, 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; 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; extended adjuvant treatment of adult patients with early stage her2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab base therapy, extended adjuvant treatment of adult patients with early stage her2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab base therapy; 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; 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, 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 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; 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, extended adjuvant treatment of adult patients with early stage her2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab base therapy; 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.

Drug patent challenges can be filed against Nerlynx from July, 2021.

The generics of Nerlynx are possible to be released after 18 July, 2031.

Patent Number Company Patent Title Patent Expiry Activity Alert
These patents protects the active chemical substance. Only 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 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)

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)

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)

US9265784 PUMA BIOTECH Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine
Aug, 2029

(6 years from now)

US9211291 PUMA BIOTECH Treatment regimen utilizing neratinib for breast cancer
Mar, 2030

(7 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

(8 years from now)

Exclusivity Exclusivity Expiration
New Chemical Entity Exclusivity (NCE) Jul 17, 2022
New Indication (I) Feb 25, 2023
New Dosing Schedule (D) Jun 28, 2024

Drugs and Companies using NERATINIB MALEATE ingredient

NCE-1 date: July, 2021

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 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; 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

Dosage: TABLET;ORAL

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