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-four 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: | 324 |
| 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 | 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 | OPZELURA | ruxolitinib phosphate | CREAM;TOPICAL | 215309-001 | Sep 21, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| 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 | 202192-005 | Nov 16, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| 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 | |||
| >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 | 54181 | HETEROARIL SUPSTITUISANI 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 |
| Eurasian Patent Organization | 202091617 | ГЕТЕРОАРИЛ-ЗАМЕЩЕННЫЕ ПИРРОЛО[2,3-B]ПИРИДИНЫ И ПИРРОЛО[2,3-B]ПИРИМИДИНЫ В КАЧЕСТВЕ ИНГИБИТОРОВ ЯНУС-КИНАЗЫ | ⤷ Try a Trial |
| Spain | 2561507 | ⤷ Try a Trial | |
| Georgia, Republic of | P20125533 | SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYL PROPANENITRILE | ⤷ Try a Trial |
| Serbia | 58113 | DERIVATI PIROLO[2,3-D]PIRIMIDINA KAO INHIBITORI JANUS KINAZE (PYRROLO[2,3-D]PYRIMIDINE DERIVATIVES AS JANUS KINASE 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 | 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 |
| 2455382 | 122017000020 | Germany | ⤷ Try a Trial | PRODUCT NAME: RUXOLITINIB, ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20150311 |
| 1966202 | C01966202/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: INCYTE CORPORATION, US |
| 1966202 | 1390005-5 | Sweden | ⤷ Try a Trial | PRODUCT NAME: RUXOLITINIB, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/12/773/001; 2012-08-23; PERIOD OF VALIDITY (FROM - UNTIL): 2026-12-13 - 2027-08-27 |
| 1966202 | C20130003 00072 | Estonia | ⤷ Try a Trial | PRODUCT NAME: RUKSOLITINIIB;REG NO/DATE: K(2012)6018 LOPLIK 23.08.2012 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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