Ruxolitinib phosphate - Generic Drug Details
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What are the generic sources for ruxolitinib phosphate and what is the scope of patent protection?
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Incyte Corp | OPZELURA | ruxolitinib phosphate | CREAM;TOPICAL | 215309-001 | Sep 21, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-002 | Nov 16, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-003 | Nov 16, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 ruxolitinib phosphate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Serbia | 55634 | HETEROARIL SUBSTITUISANI PIROLO[2,3-B]PIRIDINI I PIROLO[2,3-B]PIRIMIDINI KAO INHIBITORI JANUS KINAZE (HETEROARYL SUBSTITUTED PYRROLO[2,3-B]PYRIDINES AND PYRROLO[2,3-B]PYRIMIDINES AS JANUS KINASE INHIBITORS) | ⤷ Try a Trial |
Japan | 2017149739 | JAK阻害剤の局所製剤 (TOPICAL FORMULATION FOR JAK INHIBITOR) | ⤷ Try a Trial |
South Korea | 20180101617 | JAK 저해제에 대한 국소 제형 (TOPICAL FORMULATION FOR A JAK INHIBITOR) | ⤷ 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 | 2013/004 | Ireland | ⤷ Try a Trial | PRODUCT NAME: RUXOLITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THREOF; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823 |
1966202 | C 2013 005 | Romania | ⤷ Try a Trial | PRODUCT NAME: RUXOLITINIB SAU O SARE FARMACEUTIC ACCEPTABILA AACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/773/001, RO EU/1/12/773/002, RO EU/1/12/773/003; DATE OF NATIONAL AUTHORISATION: 20120823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/773/001, EMEA EU/1/12/773/002, EMEA EU/1/12/773/003; DATE OF FIRST AUTHORISATION IN EEA: 20120823 |
1966202 | C300574 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: RUXOLITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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