# PROLIA / XGEVA — FDA application BLA125320

Informational only - not investment advice.

Application BLA125320 · type BLA · FDA status: approved · original approval 2010-06-01

Listed sponsor: AMGEN · [AMGN company profile](/company/AMGN/) · 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 | PROLIA | DENOSUMAB | INJECTABLE | SUBCUTANEOUS | 60MG/ML | Prescription | not listed | not listed |
| 002 | XGEVA | DENOSUMAB | INJECTABLE | SUBCUTANEOUS | 70MG/ML | Prescription | not listed | not listed |

## Orange Book patent and exclusivity listings

Patent/exclusivity listings: not applicable — the FDA Orange Book covers NDA and ANDA small-molecule applications, not BLA biologics.

## Compound cross-links

- DENOSUMAB · UNII 4EQZ6YO2HI · 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/AMGN/)
- [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:BLA125320. FDA data retrieved 2026-08-07.

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