Details for New Drug Application (NDA): 216718
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NDA 216718 describes SKYCLARYS, which is a drug marketed by Reata Pharms and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug. Additional details are available on the SKYCLARYS profile page.
The generic ingredient in SKYCLARYS is omaveloxolone. Two suppliers are listed for this compound. Additional details are available on the omaveloxolone profile page.
The generic ingredient in SKYCLARYS is omaveloxolone. Two suppliers are listed for this compound. Additional details are available on the omaveloxolone profile page.
Summary for 216718
| Tradename: | SKYCLARYS |
| Applicant: | Reata Pharms |
| 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) |
| SKYCLARYS | omaveloxolone | CAPSULE;ORAL | 216718 | NDA | Reata Pharmaceuticals, Inc. | 73179-250 | 73179-250-90 | 90 CAPSULE in 1 BOTTLE (73179-250-90) |
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: | 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 | ||||||||
| Patent: | 11,091,430 | Patent Expiration: | Apr 20, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER | ||||||||
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