Details for New Drug Application (NDA): 202192
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NDA 202192 describes JAKAFI, which is a drug marketed by Incyte Corp and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JAKAFI profile page.
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.
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 202192
| Tradename: | JAKAFI |
| Applicant: | Incyte Corp |
| Ingredient: | ruxolitinib phosphate |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202192
Generic Entry Date for 202192*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 202192
| Mechanism of Action | Janus Kinase Inhibitors |
Suppliers and Packaging for NDA: 202192
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192 | NDA | Incyte Corporation | 50881-005 | 50881-005-60 | 60 TABLET in 1 BOTTLE, PLASTIC (50881-005-60) |
| JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192 | NDA | Incyte Corporation | 50881-010 | 50881-010-01 | 28 TABLET in 1 BOTTLE, PLASTIC (50881-010-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Nov 16, 2011 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 22, 2024 | ||||||||
| Regulatory Exclusivity Use: | ADDITION OF THE INDICATION OF TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER | ||||||||
| Regulatory Exclusivity Expiration: | Jun 19, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 22, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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