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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 twenty-eight patent family members in forty-five 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 June 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
Summary for JAKAFI
| International Patents: | 228 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 57 |
| Clinical Trials: | 72 |
| Patent Applications: | 494 |
| 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:
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 |
|---|---|
| MaaT Pharma | Phase 3 |
| National Marrow Donor Program | Phase 3 |
| Blood and Marrow Transplant Clinical Trials Network | Phase 3 |
Pharmacology for JAKAFI
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for JAKAFI
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
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 ⤷ Try it Free.
This potential generic entry date is based on patent ⤷ Try it Free.
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
FDA Regulatory Exclusivity protecting JAKAFI
TREATMENT OF PATIENTS WITH POLYCYTHEMIA VERA WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
Exclusivity Expiration: ⤷ Try it Free
TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (GVHD) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
Exclusivity Expiration: ⤷ Try it Free
TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (GVHD) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
Exclusivity Expiration: ⤷ Try it Free
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: ⤷ Try it Free
| 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 | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-005 | Nov 16, 2011 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-002 | Nov 16, 2011 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-002 | Nov 16, 2011 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-005 | Nov 16, 2011 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-002 | Nov 16, 2011 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Singapore | 10201912675V | ⤷ Try it Free |
| South Korea | 20150036210 | ⤷ Try it Free |
| Denmark | 2740731 | ⤷ Try it Free |
| Slovenia | 2455382 | ⤷ Try it Free |
| Eurasian Patent Organization | 201070013 | ⤷ Try it Free |
| Taiwan | 201704235 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for JAKAFI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1966202 | SPC/GB13/005 | United Kingdom | ⤷ Try it Free | PRODUCT NAME: RUXOLITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/12/773/001 20120828; UK EU/1/12/773/002 20120828; UK EU/1/12/773/003 20120828 |
| 2455382 | 132017000044713 | Italy | ⤷ Try it Free | PRODUCT NAME: RUXOLITINIB, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(JAKAVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/773/001-016, 20150313 |
| 1966202 | C01966202/01 | Switzerland | ⤷ Try it Free | FORMER OWNER: INCYTE CORPORATION, US |
| 1966202 | C20130003 00072 | Estonia | ⤷ Try it Free | PRODUCT NAME: RUKSOLITINIIB;REG NO/DATE: K(2012)6018 LOPLIK 23.08.2012 |
| 1966202 | PA2013002 | Lithuania | ⤷ Try it Free | |
| 1966202 | 92137 | Luxembourg | ⤷ Try it Free | PRODUCT NAME: RUXOLITINIB,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
