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Last Updated: December 15, 2019

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JAKAFI Drug Profile

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When do Jakafi patents expire, and when can generic versions of Jakafi launch?

Jakafi is a drug marketed by Incyte Corp and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirteen patent family members in forty-three countries.

The generic ingredient in JAKAFI is ruxolitinib phosphate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ruxolitinib phosphate profile page.

US ANDA Litigation and Generic Entry Outlook for Jakafi

Jakafi was eligible for patent challenges on November 16th, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 12th, 2028. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Drug patent expirations by year for JAKAFI
Drug Prices for JAKAFI

See drug prices for JAKAFI

Generic Entry Opportunity Date for JAKAFI
Generic Entry Date for JAKAFI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for JAKAFI

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NYU Langone HealthPhase 2
OHSU Knight Cancer InstitutePhase 1
AbbViePhase 1

See all JAKAFI clinical trials

Recent Litigation for JAKAFI

Identify potential future generic entrants

PTAB Litigation
PetitionerDate
Concert Pharmaceuticals, Inc.2017-06-27

See all JAKAFI litigation

Pharmacology for JAKAFI
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for JAKAFI
(3R)-3-Cyclopentyl-3-(4-(7H-pyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)propanenitrile phosphate (1:1)
(3R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphate
(betaR)-beta-Cyclopentyl-4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazole-1-propanenitrile phosphate
(R)-3-(4-(7H-Pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate
(R)-3-(4-(7H-Pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate;Beta-cyclopentyl-4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-(Betar)-1H-pyrazole-1-propanenitrile, phosphate
(R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrilephosphate
1092939-17-7
1H-Pyrazole-1-propanenitrile, beta-cyclopentyl-4-(7H-pyrrolo(2,3-d)pyrimidin-4-yl)-,(betaR)-, phosphate (1:1)
436LRU32H5
AK161128
AKOS024464417
AX8243856
BCP9000783
BIFK0028
CHEBI:66917
CHEMBL1795071
CS-0326
D09960
EX-A2660
FT-0674486
HY-50858
INC-424
INCB 018424
INCB 018424 phosphate
INCB-018424 Salt
INCB-18424
INCB-424
INCB018424 SALT
J-501793
Jakafi (TN)
Jakavi
Jakavi (TN)
JFMWPOCYMYGEDM-XFULWGLBSA-N
KS-000006SN
MolPort-028-912-691
OR302722
RL00400
Ruxolitinib (phosphate)
Ruxolitinib phosphate
Ruxolitinib phosphate (JAN/USAN)
Ruxolitinib phosphate [USAN]
Ruxolitinib phosphate salt
Ruxolitinib phosphate(INCB018424)
Ruxolitinib, Phosphate Salt
SB20028
SC-73865
SCHEMBL1369365
UNII-436LRU32H5
W-5760
Paragraph IV (Patent) Challenges for JAKAFI
Tradename Dosage Ingredient NDA Submissiondate
JAKAFI TABLET;ORAL ruxolitinib phosphate 202192 2015-12-17

US Patents and Regulatory Information for JAKAFI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-003 Nov 16, 2011 RX Yes No   Start Trial   Start Trial   Start Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-003 Nov 16, 2011 RX Yes No   Start Trial   Start Trial   Start Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-004 Nov 16, 2011 RX Yes No   Start Trial   Start Trial   Start Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-005 Nov 16, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for JAKAFI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1966202 C01966202/01 Switzerland   Start Trial FORMER OWNER: INCYTE CORPORATION, US
2455382 PA2017012 Lithuania   Start Trial PRODUCT NAME: RUKSOLITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/773/001-006 20150311
2455382 17C1013 France   Start Trial PRODUCT NAME: RUXOLITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/773/001-016 20150313
1966202 CR 2013 00005 Denmark   Start Trial PRODUCT NAME: RUXOLITINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB PHOSFAT; REG. NO/DATE: EU/1/12/773/001-003 20120823
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
AstraZeneca
McKesson
Moodys
Colorcon

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