grepcent public filings, reorganized for comparison

CIBINQO — FDA application NDA213871

Application NDA213871 · type NDA · FDA status: approved · original approval 2022-01-14

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
001CIBINQOABROCITINIBTABLETORAL50MGPrescriptionnot listedYes
002CIBINQOABROCITINIBTABLETORAL100MGPrescriptionnot listedYes
003CIBINQOABROCITINIBTABLETORAL200MGPrescriptionnot 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 9545405001listed patent expiry date: 2034-02-19drug substance, drug product
Patent 9545405002listed patent expiry date: 2034-02-19drug substance, drug product
Patent 9545405003listed patent expiry date: 2034-02-19drug substance, drug product
Patent 9549929001listed patent expiry date: 2034-02-19U-3195
Patent 9549929002listed patent expiry date: 2034-02-19U-3195
Patent 9549929003listed patent expiry date: 2034-02-19U-3195
Patent 9035074001listed patent expiry date: 2036-01-14drug substance, drug product
Patent 9035074002listed patent expiry date: 2036-01-14drug substance, drug product
Patent 9035074003listed patent expiry date: 2036-01-14drug substance, drug product
Exclusivity NPP001listed exclusivity date: 2026-02-09FDA code as listed
Exclusivity NPP002listed exclusivity date: 2026-02-09FDA code as listed
Exclusivity NPP003listed exclusivity date: 2026-02-09FDA code as listed
Exclusivity NCE001listed exclusivity date: 2027-01-14FDA code as listed
Exclusivity NCE002listed exclusivity date: 2027-01-14FDA code as listed
Exclusivity NCE003listed exclusivity date: 2027-01-14FDA code as listed
NDA213871 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA213871 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA213871 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 marker0.001.002.002022-01-141.002026-02-091.002027-01-141.002034-02-191.002036-01-141.00

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.