# AXIRON — FDA application NDA022504

Informational only - not investment advice.

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

Listed sponsor: ELI LILLY AND CO · [LLY company profile](/company/LLY/) · 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METERED | TRANSDERMAL | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 8993520, product 001; listed patent expiry date: 2026-06-02.
- Patent 9180194, product 001; listed patent expiry date: 2026-06-02.
- Patent 8419307, product 001; listed patent expiry date: 2027-02-26.
- Patent 8807861, product 001; listed patent expiry date: 2027-02-26.
- Patent 9289586, product 001; listed patent expiry date: 2027-02-26.
- Patent 8435944, product 001; listed patent expiry date: 2027-09-27.

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

## Compound cross-links

- TESTOSTERONE · UNII not resolved · no lmmol compound match

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

## Related pages

- [Sponsor company](/company/LLY/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA022504. FDA data retrieved 2026-08-07.

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