grepcent public filings, reorganized for comparison

ONPATTRO — FDA application NDA210922

Application NDA210922 · type NDA · FDA status: approved · original approval 2018-08-10

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
001ONPATTROPATISIRAN SODIUMSOLUTIONINTRAVENOUSEQ 10MG BASE/5ML (EQ 2MG 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 8642076001listed patent expiry date: 2027-10-03drug product
Patent 11141378001listed patent expiry date: 2029-04-15drug product
Patent 8058069001listed patent expiry date: 2029-04-15drug product
Patent 8492359001listed patent expiry date: 2029-04-15drug product
Patent 8822668001listed patent expiry date: 2029-04-15drug product, U-2378
Patent 9364435001listed patent expiry date: 2029-04-15drug product, U-2378
Patent 10240152001listed patent expiry date: 2029-10-20drug substance, drug product, U-2378
Patent 8741866001listed patent expiry date: 2029-10-20U-2378
Patent 9234196001listed patent expiry date: 2029-10-20drug product, U-2378
Patent 8802644001listed patent expiry date: 2030-10-21drug product, U-2378
Patent 8158601001listed patent expiry date: 2030-11-10drug product, U-2378
Patent 8168775001listed patent expiry date: 2032-08-10drug substance, drug product, U-2378
Patent 11079379001listed patent expiry date: 2035-08-27drug substance, drug product, U-2378
Exclusivity M-270001listed exclusivity date: 2026-01-13FDA code as listed
NDA210922 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA210922 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA210922 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 marker0.001.002.002018-08-101.002026-01-131.002027-10-031.002029-04-151.002029-10-201.002030-10-211.002030-11-101.002032-08-101.002035-08-271.00

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.