Home Applications 217180 Application 217180
Type NDA
Sponsor INCYTE CORP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 JAKAFI XR RUXOLITINIB PHOSPHATE TABLET, EXTENDED RELEASE;ORAL EQ 11MG BASE Yes No 002 JAKAFI XR RUXOLITINIB PHOSPHATE TABLET, EXTENDED RELEASE;ORAL EQ 22MG BASE Yes No 003 JAKAFI XR RUXOLITINIB PHOSPHATE TABLET, EXTENDED RELEASE;ORAL EQ 33MG BASE Yes No 004 JAKAFI XR RUXOLITINIB PHOSPHATE TABLET, EXTENDED RELEASE;ORAL EQ 44MG BASE Yes No 005 JAKAFI XR RUXOLITINIB PHOSPHATE TABLET, EXTENDED RELEASE;ORAL EQ 55MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217180-001 JAKAFI XR RUXOLITINIB PHOSPHATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2026-05-01 N217180-002 JAKAFI XR RUXOLITINIB PHOSPHATE EQ 22MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2026-05-01 N217180-003 JAKAFI XR RUXOLITINIB PHOSPHATE EQ 33MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2026-05-01 N217180-004 JAKAFI XR RUXOLITINIB PHOSPHATE EQ 44MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2026-05-01 N217180-005 JAKAFI XR RUXOLITINIB PHOSPHATE EQ 55MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2026-05-01
Orange Book patents# Current patent rows page 1 of 4 · 265 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217180-001 11744832 2026-12-12 U-3226 2026-05-28 N217180-001 11744832 2026-12-12 U-3230 2026-05-28 N217180-001 8530485 2026-12-12 Drug product 2026-05-28 N217180-001 9079912 2026-12-12 U-3226 2026-05-28 N217180-001 9079912 2026-12-12 U-3227 2026-05-28 N217180-001 9079912 2026-12-12 U-3228 2026-05-28 N217180-001 9079912 2026-12-12 U-3230 2026-05-28 N217180-001 9206187 2026-12-12 U-3227 2026-05-28 N217180-001 9206187 2026-12-12 U-3228 2026-05-28 N217180-001 9814722 2026-12-12 U-3226 2026-05-28 N217180-001 9814722 2026-12-12 U-3230 2026-05-28 N217180-001 7598257 2027-12-24 U-3227 Drug substance, Drug product 2026-05-28 N217180-001 7598257 2027-12-24 U-3228 Drug substance, Drug product 2026-05-28 N217180-001 8415362 2027-12-24 Drug substance, Drug product 2026-05-28 N217180-001 10016429 2028-06-12 U-3226 2026-05-28 N217180-001 10016429 2028-06-12 U-3230 2026-05-28 N217180-001 11213528 2028-06-12 Drug product 2026-05-28 N217180-001 8722693 2028-06-12 Drug substance, Drug product 2026-05-28 N217180-001 8822481 2028-06-12 U-3226 2026-05-28 N217180-001 8822481 2028-06-12 U-3227 2026-05-28 N217180-001 8822481 2028-06-12 U-3228 2026-05-28 N217180-001 8822481 2028-06-12 U-3230 2026-05-28 N217180-001 8829013 2028-06-12 U-3227 2026-05-28 N217180-001 8829013 2028-06-12 U-3228 2026-05-28 N217180-001 7598257*PED 2028-06-24 Pediatric extension N217180-001 8415362*PED 2028-06-24 Pediatric extension N217180-001 10016429*PED 2028-12-12 Pediatric extension N217180-001 11213528*PED 2028-12-12 Pediatric extension N217180-001 8722693*PED 2028-12-12 Pediatric extension N217180-001 8822481*PED 2028-12-12 Pediatric extension N217180-001 8829013*PED 2028-12-12 Pediatric extension N217180-001 10874616 2033-11-14 Drug product 2026-05-28 N217180-001 11576864 2033-11-14 U-3226 2026-05-28 N217180-001 11576864 2033-11-14 U-3227 2026-05-28 N217180-001 11576864 2033-11-14 U-3228 2026-05-28 N217180-001 11576864 2033-11-14 U-3230 2026-05-28 N217180-001 11576865 2033-11-14 U-3226 Drug product 2026-05-28 N217180-001 11576865 2033-11-14 U-3227 Drug product 2026-05-28 N217180-001 11576865 2033-11-14 U-3228 Drug product 2026-05-28 N217180-001 11576865 2033-11-14 U-3230 Drug product 2026-05-28 N217180-001 11896717 2033-11-14 U-3226 Drug product 2026-05-28 N217180-001 11896717 2033-11-14 U-3227 Drug product 2026-05-28 N217180-001 11896717 2033-11-14 U-3228 Drug product 2026-05-28 N217180-001 11896717 2033-11-14 U-3230 Drug product 2026-05-28 N217180-001 11337927 2034-01-17 U-3226 2026-05-28 N217180-001 11337927 2034-01-17 U-3227 2026-05-28 N217180-001 11337927 2034-01-17 U-3228 2026-05-28 N217180-001 11337927 2034-01-17 U-3230 2026-05-28 N217180-001 10874616*PED 2034-05-14 Pediatric extension N217180-001 11576864*PED 2034-05-14 Pediatric extension N217180-001 11576865*PED 2034-05-14 Pediatric extension N217180-001 11896717*PED 2034-05-14 Pediatric extension N217180-001 11337927*PED 2034-07-17 Pediatric extension N217180-002 11744832 2026-12-12 U-3226 2026-05-28 N217180-002 11744832 2026-12-12 U-3230 2026-05-28 N217180-002 8530485 2026-12-12 Drug product 2026-05-28 N217180-002 9079912 2026-12-12 U-3226 2026-05-28 N217180-002 9079912 2026-12-12 U-3227 2026-05-28 N217180-002 9079912 2026-12-12 U-3228 2026-05-28 N217180-002 9079912 2026-12-12 U-3230 2026-05-28 N217180-002 9206187 2026-12-12 U-3227 2026-05-28 N217180-002 9206187 2026-12-12 U-3228 2026-05-28 N217180-002 9814722 2026-12-12 U-3226 2026-05-28 N217180-002 9814722 2026-12-12 U-3230 2026-05-28 N217180-002 7598257 2027-12-24 U-3227 Drug substance, Drug product 2026-05-28 N217180-002 7598257 2027-12-24 U-3228 Drug substance, Drug product 2026-05-28 N217180-002 8415362 2027-12-24 Drug substance, Drug product 2026-05-28 N217180-002 10016429 2028-06-12 U-3226 2026-05-28 N217180-002 10016429 2028-06-12 U-3230 2026-05-28 N217180-002 11213528 2028-06-12 Drug product 2026-05-28 N217180-002 8722693 2028-06-12 Drug substance, Drug product 2026-05-28 N217180-002 8822481 2028-06-12 U-3226 2026-05-28 N217180-002 8822481 2028-06-12 U-3227 2026-05-28 N217180-002 8822481 2028-06-12 U-3228 2026-05-28 N217180-002 8822481 2028-06-12 U-3230 2026-05-28 N217180-002 8829013 2028-06-12 U-3227 2026-05-28 N217180-002 8829013 2028-06-12 U-3228 2026-05-28 N217180-002 7598257*PED 2028-06-24 Pediatric extension N217180-002 8415362*PED 2028-06-24 Pediatric extension N217180-002 10016429*PED 2028-12-12 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 10 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 JAKAFI XR EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2026-05-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-002 JAKAFI XR EQ 22MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2026-05-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-003 JAKAFI XR EQ 33MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2026-05-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-004 JAKAFI XR EQ 44MG BASE TABLET, EXTENDED RELEASE / ORAL RLD 2026-05-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-005 JAKAFI XR EQ 55MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2026-05-01 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 7 · 265 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 11744832 2026-12-12 U-3226 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 11744832 2026-12-12 U-3230 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 8530485 2026-12-12 Drug product 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 9079912 2026-12-12 U-3227 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 9079912 2026-12-12 U-3228 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 9079912 2026-12-12 U-3230 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 9079912 2026-12-12 U-3226 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 9206187 2026-12-12 U-3227 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 9206187 2026-12-12 U-3228 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 9814722 2026-12-12 U-3226 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 9814722 2026-12-12 U-3230 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 7598257 2027-12-24 U-3227 Drug substance, Drug product 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 7598257 2027-12-24 U-3228 Drug substance, Drug product 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 8415362 2027-12-24 Drug substance, Drug product 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 10016429 2028-06-12 U-3226 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 10016429 2028-06-12 U-3230 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 11213528 2028-06-12 Drug product 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 8722693 2028-06-12 Drug substance, Drug product 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 8822481 2028-06-12 U-3227 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 8822481 2028-06-12 U-3228 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 8822481 2028-06-12 U-3230 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 8822481 2028-06-12 U-3226 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 8829013 2028-06-12 U-3227 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 8829013 2028-06-12 U-3228 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 7598257*PED 2028-06-24 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 8415362*PED 2028-06-24 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 10016429*PED 2028-12-12 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 11213528*PED 2028-12-12 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 8722693*PED 2028-12-12 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 8822481*PED 2028-12-12 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 8829013*PED 2028-12-12 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 10874616 2033-11-14 Drug product 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 11576864 2033-11-14 U-3227 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 11576864 2033-11-14 U-3228 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 11576864 2033-11-14 U-3230 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 11576864 2033-11-14 U-3226 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 11576865 2033-11-14 U-3227 Drug product 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 11576865 2033-11-14 U-3228 Drug product 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 11576865 2033-11-14 U-3230 Drug product 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 11576865 2033-11-14 U-3226 Drug product 2026-05-28 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 ODE* 2028-09-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-001 PED 2029-03-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-002 ODE* 2028-09-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-002 PED 2029-03-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-003 ODE* 2028-09-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-003 PED 2029-03-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-004 ODE* 2028-09-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-004 PED 2029-03-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-005 ODE* 2028-09-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217180-005 PED 2029-03-22 a50c72e98297…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join JAKAFI RUXOLITINIB Incyte Corporation f1c82580-87ae-11e0-bc84-0002a5d5c51b 2026-07-20 Warnings, Adverse reactions Exact identifier application applno (NDA): 217180 application number: NDA217180
Documents# Document, Submission type, Date table Document Submission type Date 85837 ORIG 2026-05-05 85824 ORIG 2026-05-04