FDA Orange Book · active-ingredient family
Peramivir
Peramivir: 1 brand, 0 generics; first approved Dec 19, 2014; on patent until Feb 12, 2027.
On patent
Generic status & protection
Protected until Feb 12, 2027 (earliest listed patent expiry).
Earliest patent expiry Feb 12, 2027
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
2
Next patent expiry
Feb 12, 2027
in 7 mo
Originator applications
Brand (NDA) products
BIOCRYSTNDA 2064262014
BIOCRYSTNDA 2064262014
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 200MG/20ML (10MG/ML) | SOLUTION | INTRAVENOUS | Rx | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Orange Book patent file
Listed patents
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10391075 | Feb 12, 2027 | in 7 mo | U-2622 |
| 8778997 | May 07, 2027 | in 10 mo | U-2622 |
FDA approval span
Approval history
First approval
Dec 19, 2014
11 yr 9 mo ago
Most recent approval
Dec 19, 2014
11 yr 9 mo ago
All 1 application were approved in 2014.
Brand (NDA) 1100%
Generic (ANDA) 00%
Peramivir — 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.
