Details for New Drug Application (NDA): 220442
NDA 220442 describes XOCOVA, which is a drug marketed by Shionogi and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the XOCOVA profile page.
The generic ingredient in XOCOVA is ensitrelvir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ensitrelvir profile page.
The generic ingredient in XOCOVA is ensitrelvir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ensitrelvir profile page.
Summary for 220442
| Tradename: | XOCOVA |
| Applicant: | Shionogi |
| Ingredient: | ensitrelvir |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220442
Generic Entry Date for 220442*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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: 220442
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XOCOVA | ensitrelvir | TABLET;ORAL | 220442 | NDA | Shionogi Inc. | 59630-711 | 59630-711-07 | 1 BLISTER PACK in 1 CARTON (59630-711-07) / 7 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
| Approval Date: | May 29, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 29, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 11,814,368 | Patent Expiration: | May 1, 2042 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | POST-EXPOSURE PROPHYLAXIS OF CORONAVIRUS DISEASE 2019 (COVID 19) IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER | ||||||||
| Patent: | 12,559,474 | Patent Expiration: | May 1, 2042 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | POST-EXPOSURE PROPHYLAXIS OF CORONAVIRUS DISEASE 2019 (COVID 19) IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER | ||||||||
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