Neratinib Maleate Patent Expiration
Neratinib Maleate is used for treating early-stage and advanced HER2-positive breast cancer. It was first introduced by Puma Biotechnology Inc
Neratinib Maleate Patents
Given below is the list of patents protecting Neratinib Maleate, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Nerlynx | US8669273 | Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine | Jul 18, 2031 | Puma Biotech |
| Nerlynx | US7399865 | Protein tyrosine kinase enzyme inhibitors | Dec 29, 2030 | Puma Biotech |
| Nerlynx | US8518446 | Coated tablet formulations and uses thereof | Nov 20, 2030 | Puma Biotech |
| Nerlynx | US8790708 | Coated tablet formulations and uses thereof | Nov 05, 2030 | Puma Biotech |
| Nerlynx | US9211291 | Treatment regimen utilizing neratinib for breast cancer | Mar 24, 2030 | Puma Biotech |
| Nerlynx | US9265784 | Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine | Aug 04, 2029 | Puma Biotech |
| Nerlynx | US10035788 | 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 15, 2028 | Puma Biotech |
| Nerlynx | US9139558 | 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 15, 2028 | Puma Biotech |
| Nerlynx | US9630946 | 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 15, 2028 | Puma Biotech |
| Nerlynx | US7982043 | Protein tyrosine kinase enzyme inhibitors |
Oct 08, 2025
(Expired) | Puma Biotech |
| Nerlynx | US6288082 | Substituted 3-cyanoquinolines |
Sep 24, 2019
(Expired) | Puma Biotech |
Neratinib Maleate's Family Patents
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Clinical Trials
Recent Clinical Trials on Neratinib Maleate:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene | National Cancer Institute (NCI) | NA |
RECRUITING
(Sep 1, 2026)
| PHASE1 |
| Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial) | National Cancer Institute (NCI) | NA |
RECRUITING
(Sep 1, 2026)
| PHASE2 |