DrugPatentWatch Database Preview
JAKAFI Drug Profile
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 seven patents protecting this drug and one Paragraph IV challenge.
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
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 41 |
| Clinical Trials: | 33 |
| Patent Applications: | 27 |
| 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.
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 |
| (3R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid |
| (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 |
| 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 |
| FT-0674486 |
| HY-50858 |
| INC-424 |
| INCB 018424 |
| INCB-018424 Salt |
| INCB-18424 |
| INCB-424 |
| INCB018424 SALT |
| J-501793 |
| Jakafi (TN) |
| Jakavi |
| Jakavi (TN) |
| JFMWPOCYMYGEDM-XFULWGLBSA-N |
| KS-000006SN |
| MFCD18452860 |
| MolPort-028-912-691 |
| RL00400 |
| Ruxolitinib (phosphate) |
| Ruxolitinib phosphate |
| Ruxolitinib phosphate (JAN/USAN) |
| Ruxolitinib phosphate [USAN] |
| Ruxolitinib phosphate salt |
| Ruxolitinib phosphate(INCB018424) |
| Ruxolitinib, Phosphate Salt |
| SC-73865 |
| SCHEMBL1369365 |
| UNII-436LRU32H5 |
| W-5760 |
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 | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | ||
| Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-005 | Nov 16, 2011 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | ||
| Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-005 | Nov 16, 2011 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-004 | Nov 16, 2011 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for JAKAFI
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg | ➤ Subscribe | ➤ Try a Free Trial |
International Patents for JAKAFI
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Spain | 2373688 | ➤ Try a Free Trial |
| Morocco | 31517 | ➤ Try a Free Trial |
| Lithuania | PA2017012 | ➤ Try a Free Trial |
| South Korea | 101391900 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for JAKAFI
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2013 | Austria | ➤ Try a Free Trial | PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823 |
| 0130003 00072 | Estonia | ➤ Try a Free Trial | PRODUCT NAME: RUKSOLITINIIB;REG NO/DATE: K(2012)6018 LOPLIK 23.08.2012 |
| 2017000020 | Germany | ➤ Try a Free Trial | PRODUCT NAME: RUXOLITINIB, ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20150311 |
| 2017 00018 | Denmark | ➤ Try a Free Trial | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
