Details for New Drug Application (NDA): 215309
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NDA 215309 describes OPZELURA, 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 OPZELURA profile page.
The generic ingredient in OPZELURA 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 OPZELURA 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 215309
| Tradename: | OPZELURA |
| Applicant: | Incyte Corp |
| Ingredient: | ruxolitinib phosphate |
| Patents: | 17 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215309
Generic Entry Date for 215309*:
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.
Pharmacology for NDA: 215309
| Mechanism of Action | Janus Kinase Inhibitors |
Suppliers and Packaging for NDA: 215309
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OPZELURA | ruxolitinib phosphate | CREAM;TOPICAL | 215309 | NDA | Incyte Corporation | 50881-007 | 50881-007-04 | 1 TUBE in 1 CARTON (50881-007-04) / 5 g in 1 TUBE |
| OPZELURA | ruxolitinib phosphate | CREAM;TOPICAL | 215309 | NDA | Incyte Corporation | 50881-007 | 50881-007-05 | 1 TUBE in 1 CARTON (50881-007-05) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | EQ 1.5% BASE | ||||
| Approval Date: | Sep 21, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 18, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
| Regulatory Exclusivity Expiration: | Sep 21, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Jan 18, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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