grepcent public filings, reorganized for comparison

DAURISMO — FDA application NDA210656

Application NDA210656 · type NDA · FDA status: approved · original approval 2018-11-21

Listed sponsor: PFIZER · PFE 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
001DAURISMOGLASDEGIB MALEATETABLETORALEQ 25MG BASEPrescriptionnot listedYes
002DAURISMOGLASDEGIB MALEATETABLETORALEQ 100MG BASEPrescriptionnot 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 8431597001listed patent expiry date: 2028-06-29drug product
Patent 8431597002listed patent expiry date: 2028-06-29drug product
Patent 8148401001listed patent expiry date: 2032-11-21drug substance, drug product
Patent 8148401002listed patent expiry date: 2032-11-21drug substance, drug product
Patent 10414748001listed patent expiry date: 2036-04-13drug substance, drug product
Patent 10414748002listed patent expiry date: 2036-04-13drug substance, drug product
Patent 11168066001listed patent expiry date: 2036-04-13U-3254
Patent 11168066002listed patent expiry date: 2036-04-13U-3254
Patent 11891372001listed patent expiry date: 2036-04-13U-3254
Patent 11891372002listed patent expiry date: 2036-04-13U-3254
NDA210656 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA210656 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA210656 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 marker0.001.002.002018-11-211.002028-06-291.002032-11-211.002036-04-131.00

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: Large-cap biopharma

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.