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Last Updated: July 6, 2020

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NERLYNX Drug Profile


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Which patents cover Nerlynx, and what generic alternatives are available?

Nerlynx is a drug marketed by Puma Biotech and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and eighteen patent family members in twenty-nine countries.

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.

US ANDA Litigation and Generic Entry Outlook for Nerlynx

Nerlynx will be eligible for patent challenges on July 17, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 29, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for NERLYNX
Drug patent expirations by year for NERLYNX
Drug Prices for NERLYNX

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Generic Entry Opportunity Date for NERLYNX
Generic Entry Date for NERLYNX*:
Constraining patent/regulatory exclusivity:
NDA:
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 NERLYNX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Puma Biotechnology, Inc.Phase 1/Phase 2
Virginia Commonwealth UniversityPhase 1/Phase 2
NSABP Foundation IncPhase 2

See all NERLYNX clinical trials

Pharmacology for NERLYNX

US Patents and Regulatory Information for NERLYNX

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   Start Trial   Start Trial   Start Trial
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Puma Biotech NERLYNX neratinib maleate TABLET;ORAL 208051-001 Jul 17, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Baxter
Merck
Harvard Business School
Boehringer Ingelheim
Mallinckrodt

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.