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Generated: November 21, 2018

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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 nine 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:9
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
Patent:➤ Try a Free TrialPatent Expiration:Oct 15, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
Patent:➤ Try a Free TrialPatent Expiration:Sep 24, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Harvard Business School
McKinsey
Boehringer Ingelheim
Julphar
Express Scripts
US Army
Farmers Insurance
AstraZeneca

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