PRALUENT — FDA application BLA125559
Listed sponsor: REGENERON PHARMACEUTICALS · REGN 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 | PRALUENT | ALIROCUMAB | INJECTABLE | INJECTION | 75MG | Prescription | not listed | not listed |
| 002 | PRALUENT | ALIROCUMAB | INJECTABLE | INJECTION | 150MG | Prescription | not listed | not listed |
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.
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
- ALIROCUMAB · UNII PP0SHH6V16 · 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 · FDA-approved application index
Peer clusters: Large-cap biopharma
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.