grepcent public filings, reorganized for comparison

REVLIMID — FDA application NDA021880

Application NDA021880 · type NDA · FDA status: approved · original approval 2005-12-27

Listed sponsor: BRISTOL MYERS SQUIBB · BMY 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

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001REVLIMIDLENALIDOMIDECAPSULEORAL5MGPrescriptionABYes
002REVLIMIDLENALIDOMIDECAPSULEORAL10MGPrescriptionABYes
003REVLIMIDLENALIDOMIDECAPSULEORAL15MGPrescriptionABYes
004REVLIMIDLENALIDOMIDECAPSULEORAL25MGPrescriptionABYes
005REVLIMIDLENALIDOMIDECAPSULEORAL2.5MGPrescriptionABYes
006REVLIMIDLENALIDOMIDECAPSULEORAL20MGPrescriptionABYes

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

ListingProductDescriptive dateFlags/code
Patent 7465800001listed patent expiry date: 2027-04-27drug substance, drug product
Patent 7465800002listed patent expiry date: 2027-04-27drug substance, drug product
Patent 7465800003listed patent expiry date: 2027-04-27drug substance, drug product
Patent 7465800004listed patent expiry date: 2027-04-27drug substance, drug product
Patent 7465800005listed patent expiry date: 2027-04-27drug substance, drug product
Patent 7465800006listed patent expiry date: 2027-04-27drug substance, drug product
Patent 8741929001listed patent expiry date: 2028-03-08U-1983
Patent 8741929002listed patent expiry date: 2028-03-08U-1983
Patent 8741929003listed patent expiry date: 2028-03-08U-1983
Patent 8741929004listed patent expiry date: 2028-03-08U-1983
Patent 8741929005listed patent expiry date: 2028-03-08U-1983
Patent 8741929006listed patent expiry date: 2028-03-08U-1983
Exclusivity ODE-241001listed exclusivity date: 2026-05-28FDA code as listed
Exclusivity ODE-241002listed exclusivity date: 2026-05-28FDA code as listed
Exclusivity ODE-241003listed exclusivity date: 2026-05-28FDA code as listed
Exclusivity ODE-241004listed exclusivity date: 2026-05-28FDA code as listed
Exclusivity ODE-241005listed exclusivity date: 2026-05-28FDA code as listed
Exclusivity ODE-241006listed exclusivity date: 2026-05-28FDA code as listed
Exclusivity ODE-245001listed exclusivity date: 2026-05-28FDA code as listed
Exclusivity ODE-245002listed exclusivity date: 2026-05-28FDA code as listed
Exclusivity ODE-245003listed exclusivity date: 2026-05-28FDA code as listed
Exclusivity ODE-245004listed exclusivity date: 2026-05-28FDA code as listed
Exclusivity ODE-245005listed exclusivity date: 2026-05-28FDA code as listed
Exclusivity ODE-245006listed exclusivity date: 2026-05-28FDA code as listed
NDA021880 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA021880 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA021880 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002005-12-271.002026-05-281.002027-04-271.002028-03-081.00

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

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.