grepcent public filings, reorganized for comparison

TECFIDERA — FDA application NDA204063

Application NDA204063 · type NDA · FDA status: approved · original approval 2013-03-27

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
001TECFIDERADIMETHYL FUMARATECAPSULE, DELAYED RELEASEORAL120MGPrescriptionABYes
002TECFIDERADIMETHYL FUMARATECAPSULE, DELAYED RELEASEORAL240MGPrescriptionABYes

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 8399514001listed patent expiry date: 2028-02-07U-1384
Patent 8399514002listed patent expiry date: 2028-02-07U-1384
Patent 10391160001listed patent expiry date: 2035-03-13U-3148
Patent 10391160002listed patent expiry date: 2035-03-13U-3148
Patent 10555993001listed patent expiry date: 2035-03-13U-3148
Patent 10555993002listed patent expiry date: 2035-03-13U-3148
Patent 10994003001listed patent expiry date: 2035-03-13U-3148
Patent 10994003002listed patent expiry date: 2035-03-13U-3148
Patent 10959972001listed patent expiry date: 2035-11-16U-1384
Patent 10959972002listed patent expiry date: 2035-11-16U-1384
Patent 11007166001listed patent expiry date: 2035-11-16U-1384
Patent 11007166002listed patent expiry date: 2035-11-16U-1384
Patent 11007167001listed patent expiry date: 2035-11-16U-1384
Patent 11007167002listed patent expiry date: 2035-11-16U-1384
Patent 11129806001listed patent expiry date: 2035-11-16U-1384
Patent 11129806002listed patent expiry date: 2035-11-16U-1384
Patent 11246850001listed patent expiry date: 2035-11-16U-1384
Patent 11246850002listed patent expiry date: 2035-11-16U-1384
NDA204063 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA204063 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA204063 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 marker0.001.002.002013-03-271.002028-02-071.002035-03-131.002035-11-161.00

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.