grepcent public filings, reorganized for comparison

SPINRAZA — FDA application NDA209531

Application NDA209531 · type NDA · FDA status: approved · original approval 2016-12-23

Listed sponsor: BIOGEN · BIIB 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
001SPINRAZANUSINERSEN SODIUMSOLUTIONINTRATHECALEQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)Prescriptionnot listedYes
002SPINRAZANUSINERSEN SODIUMSOLUTIONINTRATHECALEQ 28MG BASE/5ML (EQ 5.6MG BASE/ML)Prescriptionnot listedYes
003SPINRAZANUSINERSEN SODIUMSOLUTIONINTRATHECALEQ 50MG BASE/5ML (EQ 10MG 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 7838657001listed patent expiry date: 2027-07-11drug substance
Patent 7838657002listed patent expiry date: 2027-07-11drug substance, drug product
Patent 7838657003listed patent expiry date: 2027-07-11drug substance, drug product
Patent 9717750001listed patent expiry date: 2030-06-17U-1942
Patent 9717750001listed patent expiry date: 2030-06-17U-2094
Patent 9717750001listed patent expiry date: 2030-06-17U-2093
Patent 9717750001listed patent expiry date: 2030-06-17U-1943
Patent 9717750002listed patent expiry date: 2030-06-17U-1943
Patent 9717750002listed patent expiry date: 2030-06-17U-2093
Patent 9717750002listed patent expiry date: 2030-06-17U-2094
Patent 9717750002listed patent expiry date: 2030-06-17U-1942
Patent 9717750003listed patent expiry date: 2030-06-17U-1943
Patent 9717750003listed patent expiry date: 2030-06-17U-2093
Patent 9717750003listed patent expiry date: 2030-06-17U-2094
Patent 9717750003listed patent expiry date: 2030-06-17U-1942
Patent 8980853001listed patent expiry date: 2030-11-24U-1941
Patent 8980853002listed patent expiry date: 2030-11-24U-1941
Patent 8980853003listed patent expiry date: 2030-11-24U-1941
Patent 8361977001listed patent expiry date: 2030-12-23drug substance, drug product
Patent 8361977002listed patent expiry date: 2030-12-23drug substance, drug product
Patent 8361977003listed patent expiry date: 2030-12-23drug substance, drug product
Patent 9926559001listed patent expiry date: 2034-01-09U-1943
Patent 10436802001listed patent expiry date: 2035-09-11U-2094
Patent 10436802001listed patent expiry date: 2035-09-11U-1943
Patent 10436802001listed patent expiry date: 2035-09-11U-1941
Patent 10436802001listed patent expiry date: 2035-09-11U-2093
Patent 10436802001listed patent expiry date: 2035-09-11U-1944
Patent 10436802001listed patent expiry date: 2035-09-11U-1942
Patent 12013403001listed patent expiry date: 2036-03-04U-1941
Patent 12013403001listed patent expiry date: 2036-03-04U-1942
Patent 12013403001listed patent expiry date: 2036-03-04U-1943
Patent 12013403001listed patent expiry date: 2036-03-04U-1944
Patent 12013403001listed patent expiry date: 2036-03-04U-2093
Patent 12013403001listed patent expiry date: 2036-03-04U-2094
Exclusivity NS002listed exclusivity date: 2029-03-27FDA code as listed
Exclusivity NS003listed exclusivity date: 2029-03-27FDA code as listed
NDA209531 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA209531 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA209531 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 marker0.001.002.002016-12-231.002027-07-111.002029-03-271.002030-06-171.002030-11-241.002030-12-231.002034-01-091.002035-09-111.002036-03-041.00

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.