Ruxolitinib phosphate - Generic Drug Details
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What are the generic sources for ruxolitinib phosphate and what is the scope of freedom to operate?
Ruxolitinib phosphate
is the generic ingredient in two branded drugs marketed by Incyte Corp and is included in two NDAs. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Ruxolitinib phosphate has three hundred and twenty-two patent family members in forty-eight countries.
There are two drug master file entries for ruxolitinib phosphate. One supplier is listed for this compound.
Summary for ruxolitinib phosphate
International Patents: | 322 |
US Patents: | 20 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 65 |
Clinical Trials: | 26 |
Patent Applications: | 916 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ruxolitinib phosphate |
DailyMed Link: | ruxolitinib phosphate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ruxolitinib phosphate
Generic Entry Dates for ruxolitinib phosphate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
Generic Entry Dates for ruxolitinib phosphate*:
Constraining patent/regulatory exclusivity:
Dosage:
CREAM;TOPICAL |
*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 ruxolitinib phosphate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Zhengzhou University | Phase 4 |
Philipps University Marburg Medical Center | Phase 2 |
Memorial Sloan Kettering Cancer Center | Phase 2 |
Pharmacology for ruxolitinib phosphate
Drug Class | Janus Kinase Inhibitor Kinase Inhibitor |
Mechanism of Action | Janus Kinase Inhibitors |
Paragraph IV (Patent) Challenges for RUXOLITINIB PHOSPHATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
OPZELURA | Cream | ruxolitinib phosphate | 1.5% | 215309 | 1 | 2023-07-31 |
JAKAFI | Tablets | ruxolitinib phosphate | 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg | 202192 | 1 | 2015-12-17 |
US Patents and Regulatory Information for ruxolitinib phosphate
International Patents for ruxolitinib phosphate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 264276 | מלחים של מדכא ג'אנוס קינאס (r)- 3- (4-(h7-פירולו[d - 2,3]פירימידין-4-איל)-1h-פיראזול-1l-איל)-3-ציקלופנטילפרופאנאניטריל (Salts of the janus kinase inhibitor (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-) | ⤷ Try a Trial |
Israel | 290637 | טיפול מקומי בויטיליגו על ידי מעכב jak (Topical treatment of vitiligo by a jak inhibitor) | ⤷ Try a Trial |
South Korea | 101921466 | ⤷ Try a Trial | |
Ecuador | SP088540 | PIRROL[2,3-b]PIRIDINAS Y PIRROL[2,3-b]PIRIMIDINAS HETEROARILO SUSTITUIDAS COMO INHIBIDORES DE QUINASAS JANUS | ⤷ Try a Trial |
Cuba | 23933 | SALES DEL INHIBIDOR DE JANUS CINASA (R)-3-(4-(7H-PIRROLO[2,3-D]PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CICLOPENTILPROPANITRILO | ⤷ Try a Trial |
Singapore | 10201506912R | HETEROARYL SUBSTITUTED PYRROLO[2,3-B]PYRIDINES AND PYRROLO[2,3-B]PYRIMIDINES AS JANUS KINASE INHIBITORS | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ruxolitinib phosphate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1966202 | 122013000015 | Germany | ⤷ Try a Trial | PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823 |
1966202 | SPC/GB13/005 | United Kingdom | ⤷ Try a Trial | 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 |
1966202 | CR 2013 00005 | Denmark | ⤷ Try a Trial | PRODUCT NAME: RUXOLITINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB PHOSFAT; REG. NO/DATE: EU/1/12/773/001-003 20120823 |
1966202 | C01966202/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: INCYTE CORPORATION, US |
1966202 | C20130003 00072 | Estonia | ⤷ Try a Trial | PRODUCT NAME: RUKSOLITINIIB;REG NO/DATE: K(2012)6018 LOPLIK 23.08.2012 |
2455382 | PA2017012 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RUKSOLITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/773/001-006 20150311 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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