Last Updated: June 22, 2026

Neratinib - Generic Drug Details

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Generic filers with tentative approvals for NERATINIB

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	40MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for Neratinib

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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	8,790,708	⤷ Start Trial	Y			⤷ Start Trial
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	8,518,446	⤷ Start Trial	Y			⤷ Start Trial
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	8,669,273	⤷ Start Trial				⤷ Start Trial
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	7,399,865	⤷ Start Trial	Y	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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