Details for New Drug Application (NDA): 217180
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NDA 217180 describes JAKAFI XR, which is a drug marketed by Incyte Corp and is included in one NDA. It is available from one supplier. There are seventeen patents protecting this drug. Additional details are available on the JAKAFI XR profile page.
The generic ingredient in JAKAFI XR 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.
The generic ingredient in JAKAFI XR 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 217180
| Tradename: | JAKAFI XR |
| Applicant: | Incyte Corp |
| Ingredient: | ruxolitinib phosphate |
| Patents: | 17 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217180
Generic Entry Date for 217180*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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 NDA: 217180
| Mechanism of Action | Janus Kinase Inhibitors |
Suppliers and Packaging for NDA: 217180
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JAKAFI XR | ruxolitinib phosphate | TABLET, EXTENDED RELEASE;ORAL | 217180 | NDA | Incyte Corporation | 50881-011 | 50881-011-08 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-011-08) |
| JAKAFI XR | ruxolitinib phosphate | TABLET, EXTENDED RELEASE;ORAL | 217180 | NDA | Incyte Corporation | 50881-022 | 50881-022-08 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-022-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 11MG BASE | ||||
| Approval Date: | May 1, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 22, 2028 | ||||||||
| Regulatory Exclusivity Use: | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) | ||||||||
| Regulatory Exclusivity Expiration: | Mar 22, 2029 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | 10,016,429*PED | Patent Expiration: | Dec 12, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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