Orange Book product · Brand (NDA)
XOCOVA
ENSITRELVIR
Brand (NDA)NDA 220442RX SHIONOGI
At a glance
May 29, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 29, 2026
21 d ago
Today
Pharmaceutical detail
Active ingredient
ENSITRELVIR
Strength
125MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 220442
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
