grepcent public filings, reorganized for comparison

JAKAFI XR — FDA application NDA217180

Application NDA217180 · type NDA · FDA status: approved · original approval 2026-05-01

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
001JAKAFI XRRUXOLITINIB PHOSPHATETABLET, EXTENDED RELEASEORALEQ 11MG BASEPrescriptionnot listedYes
002JAKAFI XRRUXOLITINIB PHOSPHATETABLET, EXTENDED RELEASEORALEQ 22MG BASEPrescriptionnot listedYes
003JAKAFI XRRUXOLITINIB PHOSPHATETABLET, EXTENDED RELEASEORALEQ 33MG BASEPrescriptionnot listedYes
004JAKAFI XRRUXOLITINIB PHOSPHATETABLET, EXTENDED RELEASEORALEQ 44MG BASEPrescriptionnot listedYes
005JAKAFI XRRUXOLITINIB PHOSPHATETABLET, EXTENDED RELEASEORALEQ 55MG 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 11744832001listed patent expiry date: 2026-12-12U-3226
Patent 11744832001listed patent expiry date: 2026-12-12U-3230
Patent 11744832002listed patent expiry date: 2026-12-12U-3226
Patent 11744832002listed patent expiry date: 2026-12-12U-3230
Patent 11744832003listed patent expiry date: 2026-12-12U-3226
Patent 11744832003listed patent expiry date: 2026-12-12U-3230
Patent 11744832004listed patent expiry date: 2026-12-12U-3226
Patent 11744832004listed patent expiry date: 2026-12-12U-3230
Patent 11744832005listed patent expiry date: 2026-12-12U-3226
Patent 11744832005listed patent expiry date: 2026-12-12U-3230
Patent 8530485001listed patent expiry date: 2026-12-12drug product
Patent 8530485002listed patent expiry date: 2026-12-12drug product
Patent 8530485003listed patent expiry date: 2026-12-12drug product
Patent 8530485004listed patent expiry date: 2026-12-12drug product
Patent 8530485005listed patent expiry date: 2026-12-12drug product
Patent 9079912001listed patent expiry date: 2026-12-12U-3227
Patent 9079912001listed patent expiry date: 2026-12-12U-3228
Patent 9079912001listed patent expiry date: 2026-12-12U-3230
Patent 9079912001listed patent expiry date: 2026-12-12U-3226
Patent 9079912002listed patent expiry date: 2026-12-12U-3227
Patent 9079912002listed patent expiry date: 2026-12-12U-3228
Patent 9079912002listed patent expiry date: 2026-12-12U-3230
Patent 9079912002listed patent expiry date: 2026-12-12U-3226
Patent 9079912003listed patent expiry date: 2026-12-12U-3227
Patent 9079912003listed patent expiry date: 2026-12-12U-3228
Patent 9079912003listed patent expiry date: 2026-12-12U-3230
Patent 9079912003listed patent expiry date: 2026-12-12U-3226
Patent 9079912004listed patent expiry date: 2026-12-12U-3227
Patent 9079912004listed patent expiry date: 2026-12-12U-3228
Patent 9079912004listed patent expiry date: 2026-12-12U-3230
Patent 9079912004listed patent expiry date: 2026-12-12U-3226
Patent 9079912005listed patent expiry date: 2026-12-12U-3227
Patent 9079912005listed patent expiry date: 2026-12-12U-3228
Patent 9079912005listed patent expiry date: 2026-12-12U-3230
Patent 9079912005listed patent expiry date: 2026-12-12U-3226
Patent 9206187001listed patent expiry date: 2026-12-12U-3227
Patent 9206187001listed patent expiry date: 2026-12-12U-3228
Patent 9206187002listed patent expiry date: 2026-12-12U-3227
Patent 9206187002listed patent expiry date: 2026-12-12U-3228
Patent 9206187003listed patent expiry date: 2026-12-12U-3227
Patent 9206187003listed patent expiry date: 2026-12-12U-3228
Patent 9206187004listed patent expiry date: 2026-12-12U-3227
Patent 9206187004listed patent expiry date: 2026-12-12U-3228
Patent 9206187005listed patent expiry date: 2026-12-12U-3227
Patent 9206187005listed patent expiry date: 2026-12-12U-3228
Patent 9814722001listed patent expiry date: 2026-12-12U-3226
Patent 9814722001listed patent expiry date: 2026-12-12U-3230
Patent 9814722002listed patent expiry date: 2026-12-12U-3226
Patent 9814722002listed patent expiry date: 2026-12-12U-3230
Patent 9814722003listed patent expiry date: 2026-12-12U-3226
Patent 9814722003listed patent expiry date: 2026-12-12U-3230
Patent 9814722004listed patent expiry date: 2026-12-12U-3226
Patent 9814722004listed patent expiry date: 2026-12-12U-3230
Patent 9814722005listed patent expiry date: 2026-12-12U-3226
Patent 9814722005listed patent expiry date: 2026-12-12U-3230
Patent 7598257001listed patent expiry date: 2027-12-24drug substance, drug product, U-3227
Patent 7598257001listed patent expiry date: 2027-12-24drug substance, drug product, U-3228
Patent 7598257002listed patent expiry date: 2027-12-24drug substance, drug product, U-3227
Patent 7598257002listed patent expiry date: 2027-12-24drug substance, drug product, U-3228
Patent 7598257003listed patent expiry date: 2027-12-24drug substance, drug product, U-3227
Patent 7598257003listed patent expiry date: 2027-12-24drug substance, drug product, U-3228
Patent 7598257004listed patent expiry date: 2027-12-24drug substance, drug product, U-3227
Patent 7598257004listed patent expiry date: 2027-12-24drug substance, drug product, U-3228
Patent 7598257005listed patent expiry date: 2027-12-24drug substance, drug product, U-3227
Patent 7598257005listed patent expiry date: 2027-12-24drug substance, drug product, U-3228
Patent 8415362001listed patent expiry date: 2027-12-24drug substance, drug product
Patent 8415362002listed patent expiry date: 2027-12-24drug substance, drug product
Patent 8415362003listed patent expiry date: 2027-12-24drug substance, drug product
Patent 8415362004listed patent expiry date: 2027-12-24drug substance, drug product
Patent 8415362005listed patent expiry date: 2027-12-24drug substance, drug product
Patent 10016429001listed patent expiry date: 2028-06-12U-3226
Patent 10016429001listed patent expiry date: 2028-06-12U-3230
Patent 10016429002listed patent expiry date: 2028-06-12U-3226
Patent 10016429002listed patent expiry date: 2028-06-12U-3230
Patent 10016429003listed patent expiry date: 2028-06-12U-3226
Patent 10016429003listed patent expiry date: 2028-06-12U-3230
Patent 10016429004listed patent expiry date: 2028-06-12U-3226
Patent 10016429004listed patent expiry date: 2028-06-12U-3230
Patent 10016429005listed patent expiry date: 2028-06-12U-3226
Patent 10016429005listed patent expiry date: 2028-06-12U-3230
Patent 11213528001listed patent expiry date: 2028-06-12drug product
Patent 11213528002listed patent expiry date: 2028-06-12drug product
Patent 11213528003listed patent expiry date: 2028-06-12drug product
Patent 11213528004listed patent expiry date: 2028-06-12drug product
Patent 11213528005listed patent expiry date: 2028-06-12drug product
Patent 8722693001listed patent expiry date: 2028-06-12drug substance, drug product
Patent 8722693002listed patent expiry date: 2028-06-12drug substance, drug product
Patent 8722693003listed patent expiry date: 2028-06-12drug substance, drug product
Patent 8722693004listed patent expiry date: 2028-06-12drug substance, drug product
Patent 8722693005listed patent expiry date: 2028-06-12drug substance, drug product
Patent 8822481001listed patent expiry date: 2028-06-12U-3227
Patent 8822481001listed patent expiry date: 2028-06-12U-3228
Patent 8822481001listed patent expiry date: 2028-06-12U-3230
Patent 8822481001listed patent expiry date: 2028-06-12U-3226
Patent 8822481002listed patent expiry date: 2028-06-12U-3227
Patent 8822481002listed patent expiry date: 2028-06-12U-3228
Patent 8822481002listed patent expiry date: 2028-06-12U-3230
Patent 8822481002listed patent expiry date: 2028-06-12U-3226
Patent 8822481003listed patent expiry date: 2028-06-12U-3227
Patent 8822481003listed patent expiry date: 2028-06-12U-3228
Patent 8822481003listed patent expiry date: 2028-06-12U-3230
Patent 8822481003listed patent expiry date: 2028-06-12U-3226
Patent 8822481004listed patent expiry date: 2028-06-12U-3227
Patent 8822481004listed patent expiry date: 2028-06-12U-3228
Patent 8822481004listed patent expiry date: 2028-06-12U-3230
Patent 8822481004listed patent expiry date: 2028-06-12U-3226
Patent 8822481005listed patent expiry date: 2028-06-12U-3227
Patent 8822481005listed patent expiry date: 2028-06-12U-3228
Patent 8822481005listed patent expiry date: 2028-06-12U-3230
Patent 8822481005listed patent expiry date: 2028-06-12U-3226
Patent 8829013001listed patent expiry date: 2028-06-12U-3227
Patent 8829013001listed patent expiry date: 2028-06-12U-3228
Patent 8829013002listed patent expiry date: 2028-06-12U-3227
Patent 8829013002listed patent expiry date: 2028-06-12U-3228
Patent 8829013003listed patent expiry date: 2028-06-12U-3227
Patent 8829013003listed patent expiry date: 2028-06-12U-3228
Patent 8829013004listed patent expiry date: 2028-06-12U-3227
Patent 8829013004listed patent expiry date: 2028-06-12U-3228
Patent 8829013005listed patent expiry date: 2028-06-12U-3227
Patent 8829013005listed patent expiry date: 2028-06-12U-3228
Patent 7598257001listed patent expiry date: 2028-06-24pediatric extension
Patent 7598257002listed patent expiry date: 2028-06-24pediatric extension
Patent 7598257003listed patent expiry date: 2028-06-24pediatric extension
Patent 7598257004listed patent expiry date: 2028-06-24pediatric extension
Patent 7598257005listed patent expiry date: 2028-06-24pediatric extension
Patent 8415362001listed patent expiry date: 2028-06-24pediatric extension
Patent 8415362002listed patent expiry date: 2028-06-24pediatric extension
Patent 8415362003listed patent expiry date: 2028-06-24pediatric extension
Patent 8415362004listed patent expiry date: 2028-06-24pediatric extension
Patent 8415362005listed patent expiry date: 2028-06-24pediatric extension
Patent 10016429001listed patent expiry date: 2028-12-12pediatric extension
Patent 10016429002listed patent expiry date: 2028-12-12pediatric extension
Patent 10016429003listed patent expiry date: 2028-12-12pediatric extension
Patent 10016429004listed patent expiry date: 2028-12-12pediatric extension
Patent 10016429005listed patent expiry date: 2028-12-12pediatric extension
Patent 11213528001listed patent expiry date: 2028-12-12pediatric extension
Patent 11213528002listed patent expiry date: 2028-12-12pediatric extension
Patent 11213528003listed patent expiry date: 2028-12-12pediatric extension
Patent 11213528004listed patent expiry date: 2028-12-12pediatric extension
Patent 11213528005listed patent expiry date: 2028-12-12pediatric extension
Patent 8722693001listed patent expiry date: 2028-12-12pediatric extension
Patent 8722693002listed patent expiry date: 2028-12-12pediatric extension
Patent 8722693003listed patent expiry date: 2028-12-12pediatric extension
Patent 8722693004listed patent expiry date: 2028-12-12pediatric extension
Patent 8722693005listed patent expiry date: 2028-12-12pediatric extension
Patent 8822481001listed patent expiry date: 2028-12-12pediatric extension
Patent 8822481002listed patent expiry date: 2028-12-12pediatric extension
Patent 8822481003listed patent expiry date: 2028-12-12pediatric extension
Patent 8822481004listed patent expiry date: 2028-12-12pediatric extension
Patent 8822481005listed patent expiry date: 2028-12-12pediatric extension
Patent 8829013001listed patent expiry date: 2028-12-12pediatric extension
Patent 8829013002listed patent expiry date: 2028-12-12pediatric extension
Patent 8829013003listed patent expiry date: 2028-12-12pediatric extension
Patent 8829013004listed patent expiry date: 2028-12-12pediatric extension
Patent 8829013005listed patent expiry date: 2028-12-12pediatric extension
Patent 10874616001listed patent expiry date: 2033-11-14drug product
Patent 10874616002listed patent expiry date: 2033-11-14drug product
Patent 10874616003listed patent expiry date: 2033-11-14drug product
Patent 10874616004listed patent expiry date: 2033-11-14drug product
Patent 10874616005listed patent expiry date: 2033-11-14drug product
Patent 11576864001listed patent expiry date: 2033-11-14U-3227
Patent 11576864001listed patent expiry date: 2033-11-14U-3228
Patent 11576864001listed patent expiry date: 2033-11-14U-3230
Patent 11576864001listed patent expiry date: 2033-11-14U-3226
Patent 11576864002listed patent expiry date: 2033-11-14U-3227
Patent 11576864002listed patent expiry date: 2033-11-14U-3228
Patent 11576864002listed patent expiry date: 2033-11-14U-3230
Patent 11576864002listed patent expiry date: 2033-11-14U-3226
Patent 11576864003listed patent expiry date: 2033-11-14U-3227
Patent 11576864003listed patent expiry date: 2033-11-14U-3228
Patent 11576864003listed patent expiry date: 2033-11-14U-3230
Patent 11576864003listed patent expiry date: 2033-11-14U-3226
Patent 11576864004listed patent expiry date: 2033-11-14U-3227
Patent 11576864004listed patent expiry date: 2033-11-14U-3228
Patent 11576864004listed patent expiry date: 2033-11-14U-3230
Patent 11576864004listed patent expiry date: 2033-11-14U-3226
Patent 11576864005listed patent expiry date: 2033-11-14U-3227
Patent 11576864005listed patent expiry date: 2033-11-14U-3228
Patent 11576864005listed patent expiry date: 2033-11-14U-3230
Patent 11576864005listed patent expiry date: 2033-11-14U-3226
Patent 11576865001listed patent expiry date: 2033-11-14drug product, U-3227
Patent 11576865001listed patent expiry date: 2033-11-14drug product, U-3228
Patent 11576865001listed patent expiry date: 2033-11-14drug product, U-3230
Patent 11576865001listed patent expiry date: 2033-11-14drug product, U-3226
Patent 11576865002listed patent expiry date: 2033-11-14drug product, U-3227
Patent 11576865002listed patent expiry date: 2033-11-14drug product, U-3228
Patent 11576865002listed patent expiry date: 2033-11-14drug product, U-3230
Patent 11576865002listed patent expiry date: 2033-11-14drug product, U-3226
Patent 11576865003listed patent expiry date: 2033-11-14drug product, U-3227
Patent 11576865003listed patent expiry date: 2033-11-14drug product, U-3228
Patent 11576865003listed patent expiry date: 2033-11-14drug product, U-3230
Patent 11576865003listed patent expiry date: 2033-11-14drug product, U-3226
Patent 11576865004listed patent expiry date: 2033-11-14drug product, U-3227
Patent 11576865004listed patent expiry date: 2033-11-14drug product, U-3228
Patent 11576865004listed patent expiry date: 2033-11-14drug product, U-3230
Patent 11576865004listed patent expiry date: 2033-11-14drug product, U-3226
Patent 11576865005listed patent expiry date: 2033-11-14drug product, U-3227
Patent 11576865005listed patent expiry date: 2033-11-14drug product, U-3228
Patent 11576865005listed patent expiry date: 2033-11-14drug product, U-3230
Patent 11576865005listed patent expiry date: 2033-11-14drug product, U-3226
Patent 11896717001listed patent expiry date: 2033-11-14drug product, U-3227
Patent 11896717001listed patent expiry date: 2033-11-14drug product, U-3228
Patent 11896717001listed patent expiry date: 2033-11-14drug product, U-3230
Patent 11896717001listed patent expiry date: 2033-11-14drug product, U-3226
Patent 11896717002listed patent expiry date: 2033-11-14drug product, U-3227
Patent 11896717002listed patent expiry date: 2033-11-14drug product, U-3228
Patent 11896717002listed patent expiry date: 2033-11-14drug product, U-3230
Patent 11896717002listed patent expiry date: 2033-11-14drug product, U-3226
Patent 11896717003listed patent expiry date: 2033-11-14drug product, U-3227
Patent 11896717003listed patent expiry date: 2033-11-14drug product, U-3228
Patent 11896717003listed patent expiry date: 2033-11-14drug product, U-3230
Patent 11896717003listed patent expiry date: 2033-11-14drug product, U-3226
Patent 11896717004listed patent expiry date: 2033-11-14drug product, U-3227
Patent 11896717004listed patent expiry date: 2033-11-14drug product, U-3228
Patent 11896717004listed patent expiry date: 2033-11-14drug product, U-3230
Patent 11896717004listed patent expiry date: 2033-11-14drug product, U-3226
Patent 11896717005listed patent expiry date: 2033-11-14drug product, U-3227
Patent 11896717005listed patent expiry date: 2033-11-14drug product, U-3228
Patent 11896717005listed patent expiry date: 2033-11-14drug product, U-3230
Patent 11896717005listed patent expiry date: 2033-11-14drug product, U-3226
Patent 11337927001listed patent expiry date: 2034-01-17U-3227
Patent 11337927001listed patent expiry date: 2034-01-17U-3228
Patent 11337927001listed patent expiry date: 2034-01-17U-3230
Patent 11337927001listed patent expiry date: 2034-01-17U-3226
Patent 11337927002listed patent expiry date: 2034-01-17U-3227
Patent 11337927002listed patent expiry date: 2034-01-17U-3228
Patent 11337927002listed patent expiry date: 2034-01-17U-3230
Patent 11337927002listed patent expiry date: 2034-01-17U-3226
Patent 11337927003listed patent expiry date: 2034-01-17U-3227
Patent 11337927003listed patent expiry date: 2034-01-17U-3228
Patent 11337927003listed patent expiry date: 2034-01-17U-3230
Patent 11337927003listed patent expiry date: 2034-01-17U-3226
Patent 11337927004listed patent expiry date: 2034-01-17U-3227
Patent 11337927004listed patent expiry date: 2034-01-17U-3228
Patent 11337927004listed patent expiry date: 2034-01-17U-3230
Patent 11337927004listed patent expiry date: 2034-01-17U-3226
Patent 11337927005listed patent expiry date: 2034-01-17U-3227
Patent 11337927005listed patent expiry date: 2034-01-17U-3228
Patent 11337927005listed patent expiry date: 2034-01-17U-3230
Patent 11337927005listed patent expiry date: 2034-01-17U-3226
Patent 10874616001listed patent expiry date: 2034-05-14pediatric extension
Patent 10874616002listed patent expiry date: 2034-05-14pediatric extension
Patent 10874616003listed patent expiry date: 2034-05-14pediatric extension
Patent 10874616004listed patent expiry date: 2034-05-14pediatric extension
Patent 10874616005listed patent expiry date: 2034-05-14pediatric extension
Patent 11576864001listed patent expiry date: 2034-05-14pediatric extension
Patent 11576864002listed patent expiry date: 2034-05-14pediatric extension
Patent 11576864003listed patent expiry date: 2034-05-14pediatric extension
Patent 11576864004listed patent expiry date: 2034-05-14pediatric extension
Patent 11576864005listed patent expiry date: 2034-05-14pediatric extension
Patent 11576865001listed patent expiry date: 2034-05-14pediatric extension
Patent 11576865002listed patent expiry date: 2034-05-14pediatric extension
Patent 11576865003listed patent expiry date: 2034-05-14pediatric extension
Patent 11576865004listed patent expiry date: 2034-05-14pediatric extension
Patent 11576865005listed patent expiry date: 2034-05-14pediatric extension
Patent 11896717001listed patent expiry date: 2034-05-14pediatric extension
Patent 11896717002listed patent expiry date: 2034-05-14pediatric extension
Patent 11896717003listed patent expiry date: 2034-05-14pediatric extension
Patent 11896717004listed patent expiry date: 2034-05-14pediatric extension
Patent 11896717005listed patent expiry date: 2034-05-14pediatric extension
Patent 11337927001listed patent expiry date: 2034-07-17pediatric extension
Patent 11337927002listed patent expiry date: 2034-07-17pediatric extension
Patent 11337927003listed patent expiry date: 2034-07-17pediatric extension
Patent 11337927004listed patent expiry date: 2034-07-17pediatric extension
Patent 11337927005listed patent expiry date: 2034-07-17pediatric extension
Exclusivity ODE*001listed exclusivity date: 2028-09-22FDA code as listed
Exclusivity ODE*002listed exclusivity date: 2028-09-22FDA code as listed
Exclusivity ODE*003listed exclusivity date: 2028-09-22FDA code as listed
Exclusivity ODE*004listed exclusivity date: 2028-09-22FDA code as listed
Exclusivity ODE*005listed exclusivity date: 2028-09-22FDA code as listed
Exclusivity PED001listed exclusivity date: 2029-03-22FDA code as listed
Exclusivity PED002listed exclusivity date: 2029-03-22FDA code as listed
Exclusivity PED003listed exclusivity date: 2029-03-22FDA code as listed
Exclusivity PED004listed exclusivity date: 2029-03-22FDA code as listed
Exclusivity PED005listed exclusivity date: 2029-03-22FDA code as listed
NDA217180 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA217180 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA217180 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 marker0.001.002.002026-05-011.002026-12-121.002027-12-241.002028-06-121.002028-06-241.002028-09-221.002028-12-121.002029-03-221.002033-11-141.002034-01-171.002034-05-141.002034-07-171.00

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.