grepcent public filings, reorganized for comparison

AMVUTTRA — FDA application NDA215515

Application NDA215515 · type NDA · FDA status: approved · original approval 2022-06-13

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
001AMVUTTRAVUTRISIRAN SODIUMSOLUTIONSUBCUTANEOUSEQ 25MG BASE/0.5ML (EQ 25MG 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-3396
Patent 10806791001listed patent expiry date: 2028-12-04drug substance
Patent 8828956001listed patent expiry date: 2028-12-04drug substance, drug product, U-3396
Patent 9370581001listed patent expiry date: 2028-12-04drug substance, drug product, U-3396
Patent 8106022001listed patent expiry date: 2029-12-12drug substance, drug product, U-3396
Patent 10570391001listed patent expiry date: 2032-11-16drug substance, drug product, U-3396
Patent 9399775001listed patent expiry date: 2032-11-16drug substance, drug product, U-3396
Patent 10612024001listed patent expiry date: 2035-08-14drug substance, drug product, U-3396
Patent 11401517001listed patent expiry date: 2035-08-14drug substance, drug product, U-3396
Patent 10208307001listed patent expiry date: 2036-07-28drug substance, drug product, U-3396
Patent 10683501001listed patent expiry date: 2036-07-28drug substance, drug product, U-3396
Patent 11286486001listed patent expiry date: 2036-07-28drug substance, drug product, U-3396
Patent 12049628001listed patent expiry date: 2036-07-28drug substance, drug product, U-3396
Exclusivity NCE001listed exclusivity date: 2027-06-13FDA code as listed
Exclusivity I-964001listed exclusivity date: 2028-03-20FDA code as listed
Exclusivity ODE-212001listed exclusivity date: 2029-06-13FDA code as listed
Exclusivity ODE-527001listed exclusivity date: 2032-03-20FDA code as listed
NDA215515 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA215515 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA215515 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 marker0.001.002.002022-06-131.002027-06-131.002028-03-201.002028-08-241.002028-12-041.002029-06-131.002029-12-121.002032-03-201.002032-11-161.002035-08-141.002036-07-281.00

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.