FDA Orange Book · active-ingredient family
Ensitrelvir
Ensitrelvir: 1 brand, 0 generics; first approved May 29, 2026.
Brand only
Generic status & protection
No listed patents or exclusivity — brand product(s) only.
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
1
Originator applications
Brand (NDA) products
SHIONOGINDA 2204422026
SHIONOGINDA 2204422026
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 125MG | TABLET | ORAL | Rx | — |
Orange Book patent file
Listed patents
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.
FDA approval span
Approval history
First approval
May 29, 2026
2 mo ago
Most recent approval
May 29, 2026
2 mo ago
All 1 application were approved in 2026.
Brand (NDA) 1100%
Generic (ANDA) 00%
Ensitrelvir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
