small molecule

NERLYNX

NERATINIB MALEATE

Loss of exclusivityJuly 2031latest FDA-listed patent expiry

CompanyPuma Biotechnology →View the full company profile on CliffBio

Drug detail

Brand name	NERLYNX
Active ingredient	NERATINIB MALEATE
Strength	EQ 40MG BASE
Dosage form	TABLET
Route	ORAL
Modality	Small molecule
FDA approval	July 2017
Marketing status	RX

Listed patents

Patent	Expires	Type
8669273	July 2031	use U-3047
7399865	December 2030	substance, product
8518446	November 2030	product
8790708	November 2030	product
9211291	March 2030	use U-3097
9265784	August 2029	use U-3047
9630946	October 2028	use U-3097
9139558	October 2028	use U-2043
10035788	October 2028	use U-3097

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.