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JAKAFI Drug 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-three 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. 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 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: | 223 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Bulk Api Vendors: | 55 |
Clinical Trials: | 52 |
Patent Applications: | 41 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for JAKAFI |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JAKAFI |
DailyMed Link: | JAKAFI at DailyMed |


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 |
---|---|
Rigel Pharmaceuticals | Phase 2 |
Incyte Corporation | Phase 3 |
Kartos Therapeutics, Inc. | Phase 1/Phase 2 |
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 | Y | Y | 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 | Y | Y | Start Trial | ||
Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-004 | Nov 16, 2011 | RX | Yes | No | 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 |
International Patents for JAKAFI
Country | Patent Number | Estimated Expiration |
---|---|---|
Australia | 2006326548 | Start Trial |
European Patent Office | 2348023 | Start Trial |
European Patent Office | 3466953 | Start Trial |
New Zealand | 581803 | Start Trial |
Portugal | 3070090 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for JAKAFI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1966202 | PA2013002,C1966202 | Lithuania | Start Trial | PRODUCT NAME: RUXOLITINIBUM; REGISTRATION NO/DATE: EU/1/12/773/001-EU/1/12/773/003, 0120823 |
2455382 | 300870 | Netherlands | Start Trial | PRODUCT NAME: RUXOLITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/773/001-016 20150313 |
1966202 | 13C0007 | France | Start Trial | PRODUCT NAME: RUXOLITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120828 |
2455382 | CR 2017 00018 | Denmark | Start Trial | PRODUCT NAME: RUXOLITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB FOSFAT; REG. NO/DATE: EU/1/12/773/001-016/C(2015)1740 20150313 |
1966202 | CA 2013 00005 | Denmark | Start Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |