NDA (New Drug Application)
ANDA (Generic Application)
Track protection status across key markets to assess launch feasibility.
It is formulated by 1 pharmaceutical company such as PUMA BIOTECH. It is marketed under 1 brand name, including NERLYNX. Available in 1 different strength, such as EQ 40MG BASE, and administered through 1 route including TABLET;ORAL.
API availability: Loading API feasibility...
Licensing: 1 potential partnersUS Launch window: Loading launch window...
Stay ahead with worldwide patent expiry and latest updates.
FDA approval history for this ingredient
Stay ahead with worldwide patent expiry insights, exclusivity data, and latest updates.
Key expiration dates for US patents covering this ingredient
Stay ahead with worldwide patent expiry insights, market data, and research updates.
Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
|---|
Patents approved by the FDA for the ingredient
|
|
Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"37186","ingredient":"NERATINIB MALEATE","trade_name":"NERLYNX","family_id":"d0159a97c0334ed5a616","publication_number":"US9078455B2","cleaned_patent_number":"7982043","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-10-08","publication_date":"2015-07-14","legal_status":"Patent Expired Due to NonPayment of Maintenance Fees Under 37 CFR 1.362"} | US7982043B2 | 14 Jul, 2015 | Patent Expired Due to NonPayment of Maintenance Fees Under 37 CFR 1.362 | 08 Oct, 2025 | |
| {"application_id":"36616","ingredient":"NERATINIB MALEATE","trade_name":"NERLYNX","family_id":"5c025a3c093d4e0db601","publication_number":"US10035788B2","cleaned_patent_number":"10035788","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-10-15","publication_date":"2018-07-31","legal_status":"Granted"} | US10035788B2 | 31 Jul, 2018 | Granted | 15 Oct, 2028 | |
| {"application_id":"36614","ingredient":"NERATINIB MALEATE","trade_name":"NERLYNX","family_id":"5c025a3c093d4e0db601","publication_number":"US9139558B2","cleaned_patent_number":"9139558","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-10-15","publication_date":"2015-09-22","legal_status":"Granted"} | US9139558B2 | 22 Sep, 2015 | Granted | 15 Oct, 2028 | |
| {"application_id":"36615","ingredient":"NERATINIB MALEATE","trade_name":"NERLYNX","family_id":"5c025a3c093d4e0db601","publication_number":"US9630946B2","cleaned_patent_number":"9630946","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-10-15","publication_date":"2017-04-25","legal_status":"Granted"} | US9630946B2 | 25 Apr, 2017 | Granted | 15 Oct, 2028 | |
| {"application_id":"36785","ingredient":"NERATINIB MALEATE","trade_name":"NERLYNX","family_id":"5344665fa5da49a5be11","publication_number":"US9265784B2","cleaned_patent_number":"9265784","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-08-04","publication_date":"2016-02-23","legal_status":"Granted"} | US9265784B2 | 23 Feb, 2016 | Granted | 04 Aug, 2029 | |
| {"application_id":"35134","ingredient":"NERATINIB MALEATE","trade_name":"NERLYNX","family_id":"055a2255387b44d19384","publication_number":"US9211291B2","cleaned_patent_number":"9211291","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-03-24","publication_date":"2015-12-15","legal_status":"Granted"} | US9211291B2 | 15 Dec, 2015 | Granted | 24 Mar, 2030 | |
| {"application_id":"34590","ingredient":"NERATINIB MALEATE","trade_name":"NERLYNX","family_id":"aec65b2984ad4828ab22","publication_number":"US8790708B2","cleaned_patent_number":"8790708","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-05","publication_date":"2014-07-29","legal_status":"Granted"} | US8790708B2 Formulation | 29 Jul, 2014 | Granted | 05 Nov, 2030 | |
| {"application_id":"34589","ingredient":"NERATINIB MALEATE","trade_name":"NERLYNX","family_id":"7912b0da78ba4745b201","publication_number":"US8518446B2","cleaned_patent_number":"8518446","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-20","publication_date":"2013-08-27","legal_status":"Granted"} | US8518446B2 Formulation | 27 Aug, 2013 | Granted | 20 Nov, 2030 | |
| {"application_id":"37187","ingredient":"NERATINIB MALEATE","trade_name":"NERLYNX","family_id":"d0159a97c0334ed5a616","publication_number":"US7399865B2","cleaned_patent_number":"7399865","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-12-29","publication_date":"2008-07-15","legal_status":"Granted"} | US7399865B2 Molecular Formulation | 15 Jul, 2008 | Granted | 29 Dec, 2030 | |
| {"application_id":"36784","ingredient":"NERATINIB MALEATE","trade_name":"NERLYNX","family_id":"5344665fa5da49a5be11","publication_number":"US8669273B2","cleaned_patent_number":"8669273","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-07-18","publication_date":"2014-03-11","legal_status":"Granted"} | US8669273B2 | 11 Mar, 2014 | Granted | 18 Jul, 2031 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
Unlock access to all suppliers of Neratinib Maleate
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.