DrugPatentWatch Database Preview
JAKAFI Drug Profile
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When do Jakafi patents expire, and when can generic versions of Jakafi launch?
This drug has one hundred and eighty-one patent family members in forty-one 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: | 181 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 43 |
| Clinical Trials: | 29 |
| Patent Applications: | 27 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JAKAFI |
| DailyMed Link: | JAKAFI at DailyMed |
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 | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-005 | Nov 16, 2011 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-005 | Nov 16, 2011 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-004 | Nov 16, 2011 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Paragraph IV (Patent) Challenges for JAKAFI
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg | ➤ Subscribe | 2015-12-17 |
Non-Orange Book US Patents for JAKAFI
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,946,245 | Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors | ➤ Sign Up |
| 9,814,722 | Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors | ➤ Sign Up |
| 8,530,485 | Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors | ➤ Sign Up |
| 9,206,187 | Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for JAKAFI
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3070090 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2007070514 | ➤ Sign Up |
| Ecuador | SP088540 | ➤ Sign Up |
| Eurasian Patent Organization | 019504 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for JAKAFI
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2017012 | Lithuania | ➤ Sign Up | PRODUCT NAME: RUKSOLITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/773/001-006 20150311 |
| 0870 | Netherlands | ➤ Sign Up | PRODUCT NAME: RUXOLITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/773/001-016 20150313 |
| 2017 00018 | Denmark | ➤ Sign Up | 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 |
| 8 | Finland | ➤ Sign Up | |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
