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 September 22, 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
Summary for JAKAFI
International Patents: | 233 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 62 |
Clinical Trials: | 75 |
Patent Applications: | 583 |
Formulation / Manufacturing: | see details |
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 Generic Entry Opportunity Date for JAKAFI
Generic Entry Date for JAKAFI*:
Constraining patent/regulatory exclusivity:
TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER 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 |
---|---|
Medical College of Wisconsin | Phase 2 |
Ohio State University Comprehensive Cancer Center | Phase 2 |
Telios Pharma, Inc. | Phase 1/Phase 2 |
Pharmacology for JAKAFI
Drug Class | Janus Kinase Inhibitor Kinase Inhibitor |
Mechanism of Action | Janus Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for JAKAFI
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 twenty-one US patents and four FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of JAKAFI is See Plans and Pricing.
This potential generic entry date is based on TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting JAKAFI
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF
Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF RUXOLITINIB (JAKAFI) FOR INHIBITING JANUS ASSOCIATED KINASES (JAKS) JAK1 AND/OR JAK2.
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF POLYCYTHEMIA VERA
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
FDA Regulatory Exclusivity protecting JAKAFI
TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (GVHD) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (GVHD) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
Exclusivity Expiration: See Plans and Pricing
ADDITION OF THE INDICATION OF TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
Exclusivity Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-005 | Nov 16, 2011 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-002 | Nov 16, 2011 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
>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: See Plans and Pricing
Brazil
Patent: 0814254
Estimated Expiration: See Plans and Pricing
Canada
Patent: 89663
Estimated Expiration: See Plans and Pricing
China
Patent: 1932582
Estimated Expiration: See Plans and Pricing
Patent: 3524509
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 51256
Estimated Expiration: See Plans and Pricing
Costa Rica
Patent: 151
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0140541
Estimated Expiration: See Plans and Pricing
Patent: 0160717
Estimated Expiration: See Plans and Pricing
Patent: 0190385
Estimated Expiration: See Plans and Pricing
Cuba
Patent: 933
Estimated Expiration: See Plans and Pricing
Patent: 179
Estimated Expiration: See Plans and Pricing
Patent: 090213
Estimated Expiration: See Plans and Pricing
Patent: 120155
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 15145
Estimated Expiration: See Plans and Pricing
Patent: 17693
Estimated Expiration: See Plans and Pricing
Patent: 21338
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 73752
Estimated Expiration: See Plans and Pricing
Patent: 40731
Estimated Expiration: See Plans and Pricing
Patent: 70090
Estimated Expiration: See Plans and Pricing
Dominican Republic
Patent: 009000280
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 099802
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 9784
Estimated Expiration: See Plans and Pricing
Patent: 1070013
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 73752
Estimated Expiration: See Plans and Pricing
Patent: 40731
Estimated Expiration: See Plans and Pricing
Patent: 70090
Estimated Expiration: See Plans and Pricing
Patent: 95369
Estimated Expiration: See Plans and Pricing
Patent: 11883
Estimated Expiration: See Plans and Pricing
Finland
Patent: 73752
Estimated Expiration: See Plans and Pricing
Georgia, Republic of
Patent: 0125533
Estimated Expiration: See Plans and Pricing
Guatemala
Patent: 0900314
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 43161
Estimated Expiration: See Plans and Pricing
Patent: 98652
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 29236
Estimated Expiration: See Plans and Pricing
Patent: 43732
Estimated Expiration: See Plans and Pricing
Israel
Patent: 2524
Estimated Expiration: See Plans and Pricing
Patent: 2410
Estimated Expiration: See Plans and Pricing
Patent: 4276
Estimated Expiration: See Plans and Pricing
Patent: 0401
Estimated Expiration: See Plans and Pricing
Patent: 7708
Estimated Expiration: See Plans and Pricing
Japan
Patent: 75653
Estimated Expiration: See Plans and Pricing
Patent: 10529209
Estimated Expiration: See Plans and Pricing
Lithuania
Patent: 70090
Estimated Expiration: See Plans and Pricing
Malaysia
Patent: 4969
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 2814
Estimated Expiration: See Plans and Pricing
Patent: 09013402
Estimated Expiration: See Plans and Pricing
Montenegro
Patent: 960
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 517
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 1803
Estimated Expiration: See Plans and Pricing
Nicaragua
Patent: 0900216
Estimated Expiration: See Plans and Pricing
Norway
Patent: 19025
Estimated Expiration: See Plans and Pricing
Poland
Patent: 73752
Estimated Expiration: See Plans and Pricing
Patent: 40731
Estimated Expiration: See Plans and Pricing
Patent: 70090
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 73752
Estimated Expiration: See Plans and Pricing
Patent: 70090
Estimated Expiration: See Plans and Pricing
San Marino
Patent: 201000002
Estimated Expiration: See Plans and Pricing
Patent: 01000002
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 245
Estimated Expiration: See Plans and Pricing
Patent: 878
Estimated Expiration: See Plans and Pricing
Patent: 449
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 2198
Estimated Expiration: See Plans and Pricing
Patent: 201509887U
Estimated Expiration: See Plans and Pricing
Patent: 201912675V
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 73752
Estimated Expiration: See Plans and Pricing
Patent: 40731
Estimated Expiration: See Plans and Pricing
Patent: 70090
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0908826
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1549876
Estimated Expiration: See Plans and Pricing
Patent: 100049010
Estimated Expiration: See Plans and Pricing
Patent: 150036210
Estimated Expiration: See Plans and Pricing
Spain
Patent: 67665
Estimated Expiration: See Plans and Pricing
Patent: 75797
Estimated Expiration: See Plans and Pricing
Patent: 14092
Estimated Expiration: See Plans and Pricing
Patent: 03444
Estimated Expiration: See Plans and Pricing
Tunisia
Patent: 09000514
Estimated Expiration: See Plans and Pricing
Turkey
Patent: 1903488
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 467
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
Hong Kong | 1124840 | HETEROARYL SUBSTITUTED PYRROLO[2,3-B]PYRIDINES AND PYRROLO[2,3- B]PYRIMIDINES AS JANUS KINASE INHIBITORS | See Plans and Pricing |
Eurasian Patent Organization | 201070013 | СОЛИ ИНГИБИТОРА ЯНУС-КИНАЗЫ (R)-3-(4-(7H-ПИРРОЛО[2,3-d]ПИРИМИДИН-4-ИЛ)-1H-ПИРАЗОЛ-1-ИЛ)-3-ЦИКЛОПЕНТИЛПРОПАННИТРИЛА | See Plans and Pricing |
Slovenia | 2426129 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JAKAFI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1966202 | 8/2013 | Austria | See Plans and Pricing | PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823 |
2455382 | 17C1013 | France | See Plans and Pricing | PRODUCT NAME: RUXOLITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/773/001-016 20150313 |
1966202 | 92137 | Luxembourg | See Plans and Pricing | PRODUCT NAME: RUXOLITINIB,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |