NERLYNX Drug Patent Profile
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Which patents cover Nerlynx, and when can generic versions of Nerlynx launch?
Nerlynx is a drug marketed by Puma Biotech and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and eighty-nine patent family members in thirty-five countries.
The generic ingredient in NERLYNX is neratinib maleate. One supplier is listed for this compound. Additional details are available on the neratinib maleate profile page.
DrugPatentWatch® Generic Entry Outlook for Nerlynx
Nerlynx was eligible for patent challenges on July 17, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 29, 2030. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (neratinib maleate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Summary for NERLYNX
| International Patents: | 189 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 132 |
| Clinical Trials: | 23 |
| Patent Applications: | 882 |
| Drug Prices: | Drug price information for NERLYNX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NERLYNX |
| What excipients (inactive ingredients) are in NERLYNX? | NERLYNX excipients list |
| DailyMed Link: | NERLYNX at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NERLYNX
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for NERLYNX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| H. Lee Moffitt Cancer Center and Research Institute | Phase 2 |
| National Comprehensive Cancer Network | Phase 2 |
Pharmacology for NERLYNX
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Kinase Inhibitors P-Glycoprotein Inhibitors |
Paragraph IV (Patent) Challenges for NERLYNX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NERLYNX | Tablets | neratinib maleate | 40 mg | 208051 | 1 | 2021-07-19 |
US Patents and Regulatory Information for NERLYNX
NERLYNX is protected by twenty-three US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NERLYNX is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting NERLYNX
Maleate salts of (E)-N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quino- linyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
Maleate salts of (E)-N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quino- linyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Maleate salts of (E)-N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quino- linyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Protein tyrosine kinase enzyme inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Protein tyrosine kinase enzyme inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
Protein tyrosine kinase enzyme inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Protein tyrosine kinase enzyme inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Coated tablet formulations and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
Coated tablet formulations and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Coated tablet formulations and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Coated tablet formulations and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
Coated tablet formulations and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Coated tablet formulations and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Maleate salts of (E)-N-{4-[3-Chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quin- olinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Maleate salts of (E)-N-{4-[3-Chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quin- olinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Maleate salts of (E)-N-{4-[3-Chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quin- olinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
Treatment regimen utilizing neratinib for breast cancer
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
Treatment regimen utilizing neratinib for breast cancer
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quin- olinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quin- olinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quin- olinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
FDA Regulatory Exclusivity protecting NERLYNX
NEW DOSING REGIMEN FOR THE PREVENTION AND MANAGEMENT OF NERATINIB‐ASSOCIATED DIARRHEA
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for NERLYNX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NERLYNX
See the table below for patents covering NERLYNX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Chile | 2008003088 | Metodo de preparacion de la sal de de maleato de (e)-n-{4-[3-cloro-4-(2-piridinilmetoxi)anilino]-3-ciano-7-etoxi-6-quinolinil}-4-(dimetilanino)-2-butenamida; formas cristalinas anhidra y monohidrato de la sal maleato; metodo de preparacion; composicion farmaceutica; utiles en el tratamiento de cancer. | ⤷ Sign Up |
| Japan | 2015127352 | （Ｅ）−Ｎ−｛４−［３−クロロ−４−（２−ピリジニルメトキシ）アニリノ］−３−シアノ−７−エトキシ−６−キノリニル｝−４−（ジメチルアミノ）−２−ブテンアミドのマレイン酸塩およびその結晶形態 (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) | ⤷ Sign Up |
| South Korea | 20130025862 | 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 | ⤷ Sign Up |
| Argentina | 078952 | FORMULACIONES DE COMPRIMIDOS REVESTIDOS | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NERLYNX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3000467 | 122023000045 | Germany | ⤷ Sign Up | PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 20180831 |
| 3000467 | PA2023520 | Lithuania | ⤷ Sign Up | PRODUCT NAME: NERATINIBAS; REGISTRATION NO/DATE: EU/1/18/1311 20230526 |
| 3000467 | 2023C/527 | Belgium | ⤷ Sign Up | PRODUCT NAME: NERATINIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1311 20180904 |
| 3000467 | LUC00310 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: NERATINIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1311 20180904 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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