Details for New Drug Application (NDA): 216718
✉ Email this page to a colleague
NDA 216718 describes SKYCLARYS, which is a drug marketed by Biogen Us and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the SKYCLARYS profile page.
The generic ingredient in SKYCLARYS is omaveloxolone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the omaveloxolone profile page.
The generic ingredient in SKYCLARYS is omaveloxolone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the omaveloxolone profile page.
Summary for 216718
| Tradename: | SKYCLARYS |
| Applicant: | Biogen Us |
| Ingredient: | omaveloxolone |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216718
Generic Entry Date for 216718*:
Constraining patent/regulatory exclusivity:
TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER Dosage:
CAPSULE;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: 216718
| Mechanism of Action | Cytochrome P450 2C8 Inducers Cytochrome P450 3A4 Inducers |
Suppliers and Packaging for NDA: 216718
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SKYCLARYS | omaveloxolone | CAPSULE;ORAL | 216718 | NDA | Biogen | 64406-250 | 64406-250-90 | 90 CAPSULE in 1 BOTTLE (64406-250-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Feb 28, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 20, 2027 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION | ||||||||
| Regulatory Exclusivity Expiration: | Feb 28, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Feb 28, 2030 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER | ||||||||
Complete Access Available with Subscription
