DrugPatentWatch Database Preview
JAKAFI Drug Profile
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 six patent family members in forty-two 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.
Summary for JAKAFI
| International Patents: | 206 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 51 |
| Clinical Trials: | 40 |
| Patent Applications: | 33 |
| 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 |
|---|---|
| NYU Langone Health | Phase 2 |
| OHSU Knight Cancer Institute | Phase 1 |
| AbbVie | Phase 1 |
Recent Litigation for JAKAFI
Identify potential future generic entrants
PTAB Litigation
| Petitioner | Date |
|---|---|
| Concert Pharmaceuticals, Inc. | 2017-06-27 |
Pharmacology for JAKAFI
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein 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 |
International Patents for JAKAFI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 2455382 | Start Trial |
| Lithuania | 3070090 | Start Trial |
| Denmark | 1966202 | Start Trial |
| Costa Rica | 10065 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for JAKAFI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1966202 | 2013C/014 | Belgium | Start Trial | PRODUCT NAME: RUXOLITINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/773/001 20120828 |
| 1966202 | 8/2013 | Austria | Start Trial | PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823 |
| 1966202 | C20130003 00072 | Estonia | Start Trial | PRODUCT NAME: RUKSOLITINIIB;REG NO/DATE: K(2012)6018 LOPLIK 23.08.2012 |
| 2455382 | 122017000020 | Germany | Start Trial | PRODUCT NAME: RUXOLITINIB, ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20150311 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
