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Last Updated: March 29, 2024

Neratinib maleate - Generic Drug Details


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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-eight 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:188
US Patents:10
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 31
Clinical Trials: 1
Patent Applications: 281
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

SponsorPhase
National Cancer Institute (NCI)Phase 1

See all neratinib maleate clinical trials

Generic filers with tentative approvals for NERATINIB MALEATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial40MGTABLET;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
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for neratinib maleate

Country Patent Number Title Estimated Expiration
Norway 2023028 ⤷  Try a Trial
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. ⤷  Try a Trial
Lithuania 3000467 ⤷  Try a Trial
South Korea 20110036604 ANTINEOPLASTIC COMBINATIONS OF 4-ANILINO-3-CYANOQUINOLINES AND CAPECITABINE ⤷  Try a Trial
Canada 2730715 COMBINAISONS ANTINEOPLASIQUES DE 4-ANILINO-3-CYANOQUINOLEINES ET DE CAPECITABINE (ANTINEOPLASTIC COMBINATIONS OF 4-ANILINO-3-CYANOQUINOLINES AND CAPECITABINE) ⤷  Try a Trial
Japan 2016147912 乳癌のための、ネラチニブを活用する治療計画 (TREATMENT REGIMEN UTILIZING NERATINIB FOR BREAST CANCER) ⤷  Try a Trial
New Zealand 595143 Treatment regimen utilizing neratinib for breast cancer ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for neratinib maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3000467 301237 Netherlands ⤷  Try a Trial PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 20180904
3000467 122023000045 Germany ⤷  Try a Trial PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 20180831
3000467 CA 2023 00021 Denmark ⤷  Try a Trial PRODUCT NAME: NERATINIB; REG. NO/DATE: EU/1/18/1311 20180904
3000467 PA2023520 Lithuania ⤷  Try a Trial PRODUCT NAME: NERATINIBAS; REGISTRATION NO/DATE: EU/1/18/1311 20230526
3000467 2023C/527 Belgium ⤷  Try a Trial PRODUCT NAME: NERATINIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1311 20180904
3000467 LUC00310 Luxembourg ⤷  Try a Trial PRODUCT NAME: NERATINIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1311 20180904
3000467 26/2023 Austria ⤷  Try a Trial PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 (MITTEILUNG) 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.