Is Puma Biotechnology, Inc. FDA approved?

Puma Biotechnology, Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Puma Biotechnology, Inc. make?

1 product is listed under Puma Biotechnology, Inc. in the openFDA NDC Directory, most often as tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Puma Biotechnology, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 1
Live patents: 9
Countries: 0

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10035788	NERLYNXneratinib maleate	use	Oct 2028
9139558	NERLYNXneratinib maleate	use	Oct 2028
9630946	NERLYNXneratinib maleate	use	Oct 2028
9265784	NERLYNXneratinib maleate	use	Aug 2029
9211291	NERLYNXneratinib maleate	use	Mar 2030
8790708	NERLYNXneratinib maleate	product	Nov 2030
8518446	NERLYNXneratinib maleate	product	Nov 2030
7399865	NERLYNXneratinib maleate	substance, product	Dec 2030
8669273	NERLYNXneratinib maleate	use	Jul 2031

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Nerlynx	neratinib	tablet, oral	70437-240NDA

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Other companies listing neratinib

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Common questions

Is Puma Biotechnology, Inc. FDA approved?: Puma Biotechnology, Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Puma Biotechnology, Inc. make?: 1 product is listed under Puma Biotechnology, Inc. in the openFDA NDC Directory, most often as tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.