| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US6288082 | PUMA BIOTECH | Substituted 3-cyanoquinolines |
Sep, 2019
(4 years ago) | |
| US7399865 | PUMA BIOTECH | Protein tyrosine kinase enzyme inhibitors |
Dec, 2030
(6 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
(1 year, 5 months 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
(4 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
(4 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
(4 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
(5 years from now) | |
| US8790708 | PUMA BIOTECH | Coated tablet formulations and uses thereof |
Nov, 2030
(6 years from now) | |
| US8518446 | PUMA BIOTECH | Coated tablet formulations and uses thereof |
Nov, 2030
(6 years from now) | |
| US8669273 | PUMA BIOTECH | Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine |
Jul, 2031
(7 years from now) | |
Nerlynx is owned by Puma Biotech.
Nerlynx contains Neratinib Maleate.
Nerlynx has a total of 11 drug patents out of which 1 drug patent has expired.
Expired drug patents of Nerlynx are:
- US6288082
Nerlynx was authorised for market use on 17 July, 2017.
Nerlynx is available in tablet;oral dosage forms.
Nerlynx can be used as 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.
Drug patent challenges can be filed against Nerlynx from 17 July, 2021.
The generics of Nerlynx are possible to be released after 18 July, 2031.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-182) | Jun 28, 2024 |
| New Chemical Entity Exclusivity(NCE) | Jul 17, 2022 |
| New Indication(I-823) | Feb 25, 2023 |
Drugs and Companies using NERATINIB MALEATE ingredient
NCE-1 date: 17 July, 2021
Market Authorisation Date: 17 July, 2017
Treatment: 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 t...
Dosage: TABLET;ORAL
NERLYNX family patents
