Details for New Drug Application (NDA): 212839
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NDA 212839 describes XCOPRI, which is a drug marketed by Sk Life and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the XCOPRI profile page.
The generic ingredient in XCOPRI is cenobamate. One supplier is listed for this compound. Additional details are available on the cenobamate profile page.
The generic ingredient in XCOPRI is cenobamate. One supplier is listed for this compound. Additional details are available on the cenobamate profile page.
Summary for 212839
| Tradename: | XCOPRI |
| Applicant: | Sk Life |
| Ingredient: | cenobamate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212839
Generic Entry Date for 212839*:
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.
Suppliers and Packaging for NDA: 212839
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XCOPRI | cenobamate | TABLET;ORAL | 212839 | NDA | SK Life Science, Inc. | 71699-025 | 71699-025-30 | 30 TABLET, FILM COATED in 1 BOTTLE (71699-025-30) |
| XCOPRI | cenobamate | TABLET;ORAL | 212839 | NDA | SK Life Science, Inc. | 71699-050 | 71699-050-30 | 30 TABLET, FILM COATED in 1 BOTTLE (71699-050-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Mar 10, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 10, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 16, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | CO-ADMINISTRATION OF CENOBAMATE WITH PHENOBARBITAL AND/OR PHENYTOIN FOR THE TREATMENT OF PARTIAL ONSET SEIZURES | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 30, 2032 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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