AXIRON — FDA application NDA022504

Application NDA022504 · type NDA · FDA status: approved · original approval 2010-11-23

Listed sponsor: ELI LILLY AND CO · LLY company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	AXIRON	TESTOSTERONE	SOLUTION, METERED	TRANSDERMAL	30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Listing	Product	Descriptive date	Flags/code
Patent 8993520	001	listed patent expiry date: 2026-06-02	U-1390
Patent 9180194	001	listed patent expiry date: 2026-06-02	U-1390
Patent 8419307	001	listed patent expiry date: 2027-02-26	U-1386
Patent 8807861	001	listed patent expiry date: 2027-02-26	drug product, U-1563
Patent 9289586	001	listed patent expiry date: 2027-02-26	U-1390
Patent 8435944	001	listed patent expiry date: 2027-09-27	U-1390

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.