JAKAFI Drug Patent Profile
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Which patents cover Jakafi, and what generic alternatives are available?
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 thirty-three patent family members in forty-six 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.
DrugPatentWatch® Generic Entry Outlook for Jakafi
Jakafi was eligible for patent challenges on November 16, 2015.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 12, 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.
Indicators of Generic Entry
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Questions you can ask:
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Summary for JAKAFI
International Patents: | 233 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 65 |
Clinical Trials: | 80 |
Patent Applications: | 394 |
Drug Prices: | Drug price information for JAKAFI |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JAKAFI |
What excipients (inactive ingredients) are in JAKAFI? | JAKAFI excipients list |
DailyMed Link: | JAKAFI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Sponsor | Phase |
---|---|
City of Hope Medical Center | Phase 2 |
Washington University School of Medicine | Phase 1 |
Karyopharm Therapeutics Inc | Phase 2 |
Pharmacology for JAKAFI
Drug Class | Janus Kinase Inhibitor Kinase Inhibitor |
Mechanism of Action | Janus Kinase Inhibitors |
Paragraph IV (Patent) Challenges for JAKAFI
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
JAKAFI | Tablets | ruxolitinib phosphate | 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg | 202192 | 1 | 2015-12-17 |
US Patents and Regulatory Information for JAKAFI
JAKAFI is protected by eight US patents and eight FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of JAKAFI is ⤷ Subscribe.
This potential generic entry date is based on patent 8,722,693.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 202192-005 | Nov 16, 2011 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-003 | Nov 16, 2011 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-002 | Nov 16, 2011 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-004 | Nov 16, 2011 | RX | Yes | No | 8,722,693*PED | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-004 | Nov 16, 2011 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for JAKAFI
When does loss-of-exclusivity occur for JAKAFI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 08266183
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 0814254
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 89663
Estimated Expiration: ⤷ Subscribe
China
Patent: 1932582
Estimated Expiration: ⤷ Subscribe
Patent: 3524509
Estimated Expiration: ⤷ Subscribe
Colombia
Patent: 51256
Estimated Expiration: ⤷ Subscribe
Costa Rica
Patent: 151
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0140541
Estimated Expiration: ⤷ Subscribe
Patent: 0160717
Estimated Expiration: ⤷ Subscribe
Patent: 0190385
Estimated Expiration: ⤷ Subscribe
Cuba
Patent: 933
Estimated Expiration: ⤷ Subscribe
Patent: 179
Estimated Expiration: ⤷ Subscribe
Patent: 090213
Estimated Expiration: ⤷ Subscribe
Patent: 120155
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 15145
Estimated Expiration: ⤷ Subscribe
Patent: 17693
Estimated Expiration: ⤷ Subscribe
Patent: 21338
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 73752
Estimated Expiration: ⤷ Subscribe
Patent: 40731
Estimated Expiration: ⤷ Subscribe
Patent: 70090
Estimated Expiration: ⤷ Subscribe
Dominican Republic
Patent: 009000280
Estimated Expiration: ⤷ Subscribe
Ecuador
Patent: 099802
Estimated Expiration: ⤷ Subscribe
Eurasian Patent Organization
Patent: 9784
Estimated Expiration: ⤷ Subscribe
Patent: 1070013
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 73752
Estimated Expiration: ⤷ Subscribe
Patent: 40731
Estimated Expiration: ⤷ Subscribe
Patent: 70090
Estimated Expiration: ⤷ Subscribe
Patent: 95369
Estimated Expiration: ⤷ Subscribe
Patent: 11883
Estimated Expiration: ⤷ Subscribe
Georgia, Republic of
Patent: 0125533
Estimated Expiration: ⤷ Subscribe
Guatemala
Patent: 0900314
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 43161
Estimated Expiration: ⤷ Subscribe
Patent: 98652
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 29236
Estimated Expiration: ⤷ Subscribe
Patent: 43732
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 2524
Estimated Expiration: ⤷ Subscribe
Patent: 4276
Estimated Expiration: ⤷ Subscribe
Patent: 0401
Estimated Expiration: ⤷ Subscribe
Patent: 7708
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 75653
Estimated Expiration: ⤷ Subscribe
Patent: 10529209
Estimated Expiration: ⤷ Subscribe
Lithuania
Patent: 70090
Estimated Expiration: ⤷ Subscribe
Malaysia
Patent: 4969
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 2814
Estimated Expiration: ⤷ Subscribe
Patent: 09013402
Estimated Expiration: ⤷ Subscribe
Montenegro
Patent: 960
Estimated Expiration: ⤷ Subscribe
Morocco
Patent: 517
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 1803
Estimated Expiration: ⤷ Subscribe
Nicaragua
Patent: 0900216
Estimated Expiration: ⤷ Subscribe
Norway
Patent: 19025
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 73752
Estimated Expiration: ⤷ Subscribe
Patent: 40731
Estimated Expiration: ⤷ Subscribe
Patent: 70090
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 73752
Estimated Expiration: ⤷ Subscribe
Patent: 70090
Estimated Expiration: ⤷ Subscribe
San Marino
Patent: 201000002
Patent: Sali dell'inibitore di chinasi janus (r)-3-(4-(7h-pirrolo[2,3-d]pirimidin-4-il)-1h-pirazoli-1-il)-3-ciclopentilpropanonitrile
Estimated Expiration: ⤷ Subscribe
Patent: 01000002
Patent: Sali dell'inibitore di chinasi janus (R)-3-(4-(7H-pirrolo[2,3-D]pirimidin-4-IL)-1H-pirazoli-1-IL)-3-ciclopentilpropanonitrile
Estimated Expiration: ⤷ Subscribe
Serbia
Patent: 245
Patent: SOLI INHIBITORA JANUS KINAZE (R)-3-(4-(7H-PIROLO(2,3-D) PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CIKLOPENTILPROPAN-NITRILA (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO(2,3-D)PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷ Subscribe
Patent: 878
Patent: KRISTALNE SOLI INHIBITORA JANUS KINAZE (R)-3-(4-(7H-PIROLO[2,3-D]PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CIKLOPENTILPROPIONITRIL (CRYSTALLINE SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷ Subscribe
Patent: 449
Patent: UPOTREBA SOLI INHIBITORA JANUS KINAZE (R)-3-(4-(7H-PIROLO[2,3-D]PIRIMIDIN-4-IL)-1H- PIRAZOL-1-IL)-3-CIKLOPENTILPROPIONITRILA (USE OF SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H- PYRAZOL-1-YL)-3- CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷ Subscribe
Singapore
Patent: 2198
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷ Subscribe
Patent: 201509887U
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷ Subscribe
Patent: 201912675V
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 73752
Estimated Expiration: ⤷ Subscribe
Patent: 40731
Estimated Expiration: ⤷ Subscribe
Patent: 70090
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 0908826
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTHYLPROPANEITRILE
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1549876
Estimated Expiration: ⤷ Subscribe
Patent: 100049010
Estimated Expiration: ⤷ Subscribe
Patent: 150036210
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 67665
Estimated Expiration: ⤷ Subscribe
Patent: 75797
Estimated Expiration: ⤷ Subscribe
Patent: 14092
Estimated Expiration: ⤷ Subscribe
Patent: 03444
Estimated Expiration: ⤷ Subscribe
Tunisia
Patent: 09000514
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R) -3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷ Subscribe
Turkey
Patent: 1903488
Estimated Expiration: ⤷ Subscribe
Ukraine
Patent: 467
Patent: СОЛІ ІНГІБІТОРА ЯНУС-КІНАЗИ (R)-3-(4-(7H-ПІРОЛО[2,3-d]ПІРИМІДИН-4-ІЛ)-1H-ПІРАЗОЛ-1-ІЛ)-3-ЦИКЛОПЕНТИЛПРОПАННІТРИЛУ[СОЛИ ИНГИБИТОРА ЯНУС-КИНАЗЫ (R)-3-(4-(7H-ПИРРОЛО[2,3-d]ПИРИМИДИН-4-ИЛ)-1H-ПИРАЗОЛ-1-ИЛ)-3-ЦИКЛОПЕНТИЛПРОПАННИТРИЛА (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-d]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷ Subscribe
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering JAKAFI around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Singapore | 10201509887U | SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE | ⤷ Subscribe |
Tunisia | 2009000514 | SALTS OF THE JANUS KINASE INHIBITOR (R) -3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE | ⤷ Subscribe |
Spain | 2543903 | ⤷ Subscribe | |
Eurasian Patent Organization | 200870048 | ГЕТЕРОАРИЛ-ЗЕМЕЩЕННЫЕ ПИРРОЛО[2,3-b]ПИРИДИНЫ И ПИРРОЛО[2,3-b]ПИРИМИДИНЫ В КАЧЕСТВЕ ИНГИБИТОРОВ ЯНУС-КИНАЗЫ | ⤷ Subscribe |
South Africa | 200805165 | HETEROARLY SUBSTITUTED PYRROL [2,3-B] PYRIDINES AND PYRROLO [2,3-B] PYRIMIDINES AS JANUS KINASE INHIBITORS | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JAKAFI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1966202 | 92137 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: RUXOLITINIB,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
1966202 | C01966202/01 | Switzerland | ⤷ Subscribe | FORMER OWNER: INCYTE CORPORATION, US |
2455382 | CA 2017 00018 | Denmark | ⤷ Subscribe | PRODUCT NAME: RUXOLITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB FOSFAT; REG. NO/DATE: C(2015)1740/EU/1/12/773/001-016 20150313 |
1966202 | 448 | Finland | ⤷ Subscribe | |
1966202 | PA2013002 | Lithuania | ⤷ Subscribe | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
JAKAFI Market Analysis and Financial Projection Experimental
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