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Last Updated: December 3, 2022

Neratinib maleate - Generic Drug Details


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What are the generic sources for neratinib maleate and what is the scope of patent protection?

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 sixty-one patent family members in thirty-one countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for neratinib maleate
International Patents:161
US Patents:10
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 27
Clinical Trials: 1
Patent Applications: 308
DailyMed Link:neratinib maleate at DailyMed
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
See Plans and PricingSee Plans and Pricing40MGTABLET;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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
Mexico 342681 SALES DE MALEATO DE (E)-N-{4-[3-CLORO-4-(2-PIRIDINILMETOXI)ANILINO ]-3-CIANO-7-ETOXI-6-QUINOLINIL)-4-(DIMETILAMINO)-2-BUTENAMIDA Y SUS FORMAS CRISTALINAS. (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.) See Plans and Pricing
South Korea 20190128004 네라티닙을 이용한 유방암의 치료법 (TREATMENT REGIMEN UTILIZING NERATINIB FOR BREAST CANCER) See Plans and Pricing
Argentina 114143 FORMULACIONES DE COMPRIMIDOS REVESTIDOS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Express Scripts
AstraZeneca
McKesson
Moodys

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.