grepcent public filings, reorganized for comparison

GIVLAARI — FDA application NDA212194

Application NDA212194 · type NDA · FDA status: approved · original approval 2019-11-20

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
001GIVLAARIGIVOSIRAN SODIUMSOLUTIONSUBCUTANEOUSEQ 189MG BASE/ML (EQ 189MG BASE/ML)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-2672
Patent 8828956001listed patent expiry date: 2028-12-04drug substance, drug product, U-2672
Patent 8106022001listed patent expiry date: 2029-12-12drug substance, drug product, U-2672
Patent 10125364001listed patent expiry date: 2033-03-15drug substance, drug product, U-2672
Patent 9631193001listed patent expiry date: 2033-03-15U-2672
Patent 9133461001listed patent expiry date: 2033-11-30drug substance, drug product, U-2672
Patent 10119143001listed patent expiry date: 2034-10-03drug substance, drug product, U-2672
Patent 11028392001listed patent expiry date: 2034-10-03drug substance, drug product, U-2672
Exclusivity ODE-273001listed exclusivity date: 2026-11-20FDA code as listed
NDA212194 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA212194 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA212194 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 marker0.001.002.002019-11-201.002026-11-201.002028-08-241.002028-12-041.002029-12-121.002033-03-151.002033-11-301.002034-10-031.00

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.