grepcent public filings, reorganized for comparison

OXLUMO — FDA application NDA214103

Application NDA214103 · type NDA · FDA status: approved · original approval 2020-11-23

Listed sponsor: ALNYLAM PHARMS INC · ALNY 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
001OXLUMOLUMASIRAN SODIUMSOLUTIONSUBCUTANEOUSEQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)Prescriptionnot listedYes

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 10131907001listed patent expiry date: 2028-08-24drug substance, drug product, U-2995
Patent 8828956001listed patent expiry date: 2028-12-04drug substance, drug product, U-2995
Patent 8106022001listed patent expiry date: 2029-12-12drug substance, drug product, U-2995
Patent 10435692001listed patent expiry date: 2034-12-26U-2995
Patent 10465195001listed patent expiry date: 2034-12-26drug substance, drug product, U-2995
Patent 10487330001listed patent expiry date: 2034-12-26drug substance, drug product, U-2995
Patent 11060093001listed patent expiry date: 2034-12-26drug substance, drug product, U-2995
Patent 9828606001listed patent expiry date: 2034-12-26drug substance, drug product
Patent 10612024001listed patent expiry date: 2035-08-14drug substance, drug product, U-2995
Patent 10612027001listed patent expiry date: 2035-08-14drug substance, drug product, U-2995
Patent 11401517001listed patent expiry date: 2035-08-14drug substance, drug product, U-2995
Patent 10478500001listed patent expiry date: 2035-10-09drug substance, drug product, U-2995
Patent 11446380001listed patent expiry date: 2035-10-09drug substance, drug product
Patent 11261447001listed patent expiry date: 2038-11-20drug substance, drug product, U-2995
Exclusivity ODE-339001listed exclusivity date: 2027-11-23FDA code as listed
Exclusivity ODE-415001listed exclusivity date: 2029-10-06FDA code as listed
NDA214103 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA214103 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA214103 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 marker0.001.002.002020-11-231.002027-11-231.002028-08-241.002028-12-041.002029-10-061.002029-12-121.002034-12-261.002035-08-141.002035-10-091.002038-11-201.00

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: No published peer-cluster link for this sponsor.

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.