Is Loxo Oncology, Inc. FDA approved?

Loxo Oncology, Inc. holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Loxo Oncology, Inc. make?

3 products are listed under Loxo Oncology, Inc. in the openFDA NDC Directory, most often as capsule; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Loxo Oncology, Inc.

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

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Registered sites: 0
Active NDC listings: 3
Live patents: 14
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human prescription drug. By marketing category: NDA 3.

Dosage form	NDCs
capsule	2
solution	1

Route	NDCs
oral	3

Labeller name on the listing	NDCs
loxo oncology, inc.	3

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10342780	JAYPIRCApirtobrutinib	substance, product	Dec 2036
10464905	JAYPIRCApirtobrutinib	use	Dec 2036
10695323	JAYPIRCApirtobrutinib	substance, product	Dec 2036
10918622	JAYPIRCApirtobrutinib	use	Dec 2036
12220401	JAYPIRCApirtobrutinib	substance, product	Dec 2036
12268666	JAYPIRCApirtobrutinib	product	Jul 2039
12109193	JAYPIRCApirtobrutinib	product	Sept 2041

Product	Exclusivity	Until
JAYPIRCAPIRTOBRUTINIB	ODE-518 Orphan drug	Dec 2032

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
VITRAKVI	LAROTRECTINIB	capsule, oral	71777-390NDA
VITRAKVI	LAROTRECTINIB	capsule, oral	71777-391NDA
VITRAKVI	LAROTRECTINIB	solution, oral	71777-392NDA

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Other companies listing larotrectinib

Bayer Healthcare Manufacturing Srl13 sites · 360 NDC

Enquiry

Common questions

Is Loxo Oncology, Inc. FDA approved?: Loxo Oncology, Inc. holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Loxo Oncology, Inc. make?: 3 products are listed under Loxo Oncology, Inc. in the openFDA NDC Directory, most often as capsule; solution. 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.