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
availability in other generic markets.
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