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Last Updated: December 6, 2022

Details for New Drug Application (NDA): 208051


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NDA 208051 describes NERLYNX, which is a drug marketed by Puma Biotech and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the NERLYNX profile page.

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.
Summary for 208051
Tradename:NERLYNX
Applicant:Puma Biotech
Ingredient:neratinib maleate
Patents:10
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 208051
Generic Entry Date for 208051*:
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.

Pharmacology for NDA: 208051
Suppliers and Packaging for NDA: 208051
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NERLYNX neratinib maleate TABLET;ORAL 208051 NDA Puma Biotechnology, Inc. 70437-240 70437-240-18 1 BOTTLE in 1 BOX (70437-240-18) > 180 TABLET in 1 BOTTLE
NERLYNX neratinib maleate TABLET;ORAL 208051 NDA Puma Biotechnology, Inc. 70437-240 70437-240-26 1 BOTTLE in 1 BOX (70437-240-26) > 126 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Jul 17, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 17, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jun 28, 2024
Regulatory Exclusivity Use:NEW DOSING REGIMEN FOR THE PREVENTION AND MANAGEMENT OF NERATINIB-ASSOCIATED DIARRHEA
Regulatory Exclusivity Expiration:Feb 25, 2023
Regulatory Exclusivity 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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Moodys
Baxter
McKinsey
AstraZeneca

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.