ruxolitinib Oral Tablet

Brand(s)
Jakafi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Incyte Corporation (2014-12-12)
Oldest Current Product
2011-11-16
License(s)
NDA
RxNORM
ORAL TABLET\RUXOLITINIB
FDAOB
ORAL\TABLET\RUXOLITINIB PHOSPHATE
SPL Active
ORAL\TABLET\RUXOLITINIB
SPL Moiety
ORAL\TABLET\RUXOLITINIB

product(s) by strength(s)

ruxolitinib 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1508810010JakafiNDAIncyte Corporation2011-11-16RUXOLITINIBORALTABLETNDA202192f1c82580-87ae-11e0-bc84-0002a5d5c51b

ruxolitinib 15 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1508810015JakafiNDAIncyte Corporation2011-11-16RUXOLITINIBORALTABLETNDA202192f1c82580-87ae-11e0-bc84-0002a5d5c51b

ruxolitinib 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1508810020JakafiNDAIncyte Corporation2011-11-16RUXOLITINIBORALTABLETNDA202192f1c82580-87ae-11e0-bc84-0002a5d5c51b

ruxolitinib 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1508810025JakafiNDAIncyte Corporation2011-11-16RUXOLITINIBORALTABLETNDA202192f1c82580-87ae-11e0-bc84-0002a5d5c51b

ruxolitinib 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1508810005JakafiNDAIncyte Corporation2011-11-16RUXOLITINIBORALTABLETNDA202192f1c82580-87ae-11e0-bc84-0002a5d5c51b

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202192JAKAFIINCYTE CORP2011-11-16p8415362, SUBSTANCE
p9079912, USE OF RUXOLITINIB (JAKAFI) FOR INHIBITING JANUS ASSOCIATED KINASES (JAKS) JAK1 AND/OR JAK2./ USE OF RUXOLITINIB (JAKAFI) FOR BLOCKING SIGNAL TRANSDUCTION OF JANUS ASSOCIATED KINASES (JAKS) JAK1 AND/OR JAK2
p8722693, SUBSTANCE
p8829013, FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS/ FOR THE TREATMENT OF POLYCYTHEMIA VERA
p8822481, USE OF RUXOLITINIB (JAKAFI) FOR INHIBITING JANUS ASSOCIATED KINASES (JAKS) JAK1 AND/OR JAK2.
p7598257, FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS/ FOR THE TREATMENT OF POLYCYTHEMIA VERA, SUBSTANCE
FOR TREATMENT OF PATIENTS WITH POLYCYTHEMIA VERA WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA [2017-12-04]
NEW CHEMICAL ENTITY [2016-11-16]
ORPHAN DRUG EXCLUSIVITY [2021-12-04]
ORPHAN DRUG EXCLUSIVITY [2018-11-16]
NDA202192_001, NDA202192_002, NDA202192_003, NDA202192_004, NDA202192_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202192_001RXRUXOLITINIB PHOSPHATE (EQ 5MG BASE)ORALTABLETFalse2011-11-16JAKAFI
2NDA202192_002RXRUXOLITINIB PHOSPHATE (EQ 10MG BASE)ORALTABLETFalse2011-11-16JAKAFI
3NDA202192_003RXRUXOLITINIB PHOSPHATE (EQ 15MG BASE)ORALTABLETFalse2011-11-16JAKAFI
4NDA202192_004RXRUXOLITINIB PHOSPHATE (EQ 20MG BASE)ORALTABLETFalse2011-11-16JAKAFI
5NDA202192_005RXRUXOLITINIB PHOSPHATE (EQ 25MG BASE)ORALTABLETTrue2011-11-16JAKAFI

patent(s)

#idexpiration dateapplication(s)
1p7598257 (view patent)2027-12-24NDA202192
2p8415362 (view patent)2027-12-24NDA202192
3p8722693 (view patent)2028-06-12NDA202192
4p8822481 (view patent)2028-06-12NDA202192
5p8829013 (view patent)2028-06-12NDA202192
6p9079912 (view patent)2026-12-12NDA202192

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1f1c82580-87ae-11e0-bc84-0002a5d5c51b (view SPL)These highlights do not include all the information needed to use JAKAFI safely and effectively. See full prescribing information for JAKAFI. JAKAFI (ruxolitinib) tablets, for oral use Initial U.S. Approval: 2011prescriptionHuman PrescriptionIncyte CorporationANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-12-1213508810005, 508810010, 508810015, 508810020, 508810025

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII