grepcent public filings, reorganized for comparison

OPZELURA — FDA application NDA215309

Application NDA215309 · type NDA · FDA status: approved · original approval 2021-09-21

Listed sponsor: INCYTE CORP · INCY 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
001OPZELURARUXOLITINIB PHOSPHATECREAMTOPICALEQ 1.5% 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 10639310001listed patent expiry date: 2026-12-12U-3229
Patent 9079912001listed patent expiry date: 2026-12-12U-3404
Patent 9079912001listed patent expiry date: 2026-12-12U-3229
Patent 9974790001listed patent expiry date: 2026-12-12U-3404
Patent 9974790001listed patent expiry date: 2026-12-12U-3229
Patent 10639310001listed patent expiry date: 2027-06-12pediatric extension
Patent 9079912001listed patent expiry date: 2027-06-12pediatric extension
Patent 9974790001listed patent expiry date: 2027-06-12pediatric extension
Patent 7598257001listed patent expiry date: 2027-12-24drug substance, drug product
Patent 8415362001listed patent expiry date: 2027-12-24drug substance, drug product
Patent 10610530001listed patent expiry date: 2028-06-12U-3404
Patent 10610530001listed patent expiry date: 2028-06-12U-3229
Patent 8722693001listed patent expiry date: 2028-06-12drug substance, drug product
Patent 8822481001listed patent expiry date: 2028-06-12U-3404
Patent 8822481001listed patent expiry date: 2028-06-12U-3229
Patent 7598257001listed patent expiry date: 2028-06-24pediatric extension
Patent 8415362001listed patent expiry date: 2028-06-24pediatric extension
Patent 10610530001listed patent expiry date: 2028-12-12pediatric extension
Patent 8722693001listed patent expiry date: 2028-12-12pediatric extension
Patent 8822481001listed patent expiry date: 2028-12-12pediatric extension
Patent 10758543001listed patent expiry date: 2031-05-20drug product
Patent 10869870001listed patent expiry date: 2031-05-20U-3404
Patent 10869870001listed patent expiry date: 2031-05-20U-3229
Patent 11219624001listed patent expiry date: 2031-05-20drug product, U-3229
Patent 11571425001listed patent expiry date: 2031-05-20drug product
Patent 11590136001listed patent expiry date: 2031-05-20U-3229
Patent 11590136001listed patent expiry date: 2031-05-20U-3404
Patent 12226419001listed patent expiry date: 2031-05-20drug product
Patent 12544381001listed patent expiry date: 2031-05-20drug product
Patent 12564593001listed patent expiry date: 2031-05-20drug product
Patent 10758543001listed patent expiry date: 2031-11-20pediatric extension
Patent 10869870001listed patent expiry date: 2031-11-20pediatric extension
Patent 11219624001listed patent expiry date: 2031-11-20pediatric extension
Patent 11590138001listed patent expiry date: 2040-06-10U-3551
Patent 12233067001listed patent expiry date: 2040-07-28U-4151
Patent 11510923001listed patent expiry date: 2040-09-04U-3505
Patent 11590137001listed patent expiry date: 2040-09-04U-3505
Patent 12589096001listed patent expiry date: 2040-09-04U-3505
Patent 11602536001listed patent expiry date: 2041-05-05U-3550
Exclusivity I-896001listed exclusivity date: 2025-07-18FDA code as listed
Exclusivity PED001listed exclusivity date: 2026-01-18FDA code as listed
Exclusivity NPP001listed exclusivity date: 2028-09-18FDA code as listed
NDA215309 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA215309 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA215309 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 marker0.001.002.00

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.