NERATINIB MALEATE - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for neratinib maleate and what is the scope of freedom to operate?
Neratinib maleate
is the generic ingredient in one branded drug marketed by Puma Biotech and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.Neratinib maleate has one hundred and eighty-nine patent family members in thirty-five countries.
One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for NERATINIB MALEATE
International Patents: | 189 |
US Patents: | 10 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 31 |
Clinical Trials: | 3 |
Patent Applications: | 281 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NERATINIB MALEATE |
DailyMed Link: | NERATINIB MALEATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NERATINIB MALEATE
Generic Entry Date for NERATINIB MALEATE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*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 NERATINIB MALEATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 2 |
National Cancer Institute (NCI) | Phase 1 |
Korea University Guro Hospital | Phase 2 |
Generic filers with tentative approvals for NERATINIB MALEATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 40MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for NERATINIB MALEATE
Drug Class | Kinase Inhibitor |
Mechanism of Action | Kinase Inhibitors P-Glycoprotein Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for NERATINIB MALEATE
Paragraph IV (Patent) Challenges for NERATINIB MALEATE
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 NERATINIB MALEATE
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 NERATINIB MALEATE
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 NERATINIB MALEATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101208301 | ⤷ Sign Up | |
China | 105147713 | Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine | ⤷ Sign Up |
Taiwan | I557108 | ⤷ Sign Up | |
Israel | 215166 | משטר טיפול לסרטן השד העושה שימוש בנראטיניב (Treatment regimen utilizing neratinib for breast cancer) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NERATINIB MALEATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3000467 | 2023C/527 | Belgium | ⤷ Sign Up | PRODUCT NAME: NERATINIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1311 20180904 |
3000467 | PA2023520 | Lithuania | ⤷ Sign Up | PRODUCT NAME: NERATINIBAS; REGISTRATION NO/DATE: EU/1/18/1311 20230526 |
3000467 | LUC00310 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: NERATINIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1311 20180904 |
3000467 | 26/2023 | Austria | ⤷ Sign Up | PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 (MITTEILUNG) 20180904 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.