Orange Book product · Brand (NDA)
TPOXX
TECOVIRIMAT
At a glance
May 18, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 18, 2022
4 yr 2 mo ago
Today
Patent 8039504 expires
Listed drug product patent expiration.
Jul 23, 2027
in 1 yr 1 mo
Patent 10576165 expires
Listed drug product patent expiration.
Aug 02, 2031
in 5 yr 2 mo
Patent 9233097 expires
Listed drug product patent expiration.
Aug 02, 2031
in 5 yr 2 mo
Patent 9907859 expires
Listed method-of-use patent (U-3377) expiration.
Aug 02, 2031
in 5 yr 2 mo
Patent 7737168 expires
Listed method-of-use patent (U-3377) expiration.
Sep 04, 2031
in 5 yr 3 mo
Pharmaceutical detail
Active ingredient
TECOVIRIMAT
Strength
200MG/20ML (10MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 214518
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 (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8039504 | Jul 23, 2027 | in 1 yr 1 mo | Product |
| 10576165 | Aug 02, 2031 | in 5 yr 2 mo | Product |
| 9233097 | Aug 02, 2031 | in 5 yr 2 mo | Product |
| 9907859 | Aug 02, 2031 | in 5 yr 2 mo | U-3377 |
| 7737168 | Sep 04, 2031 | in 5 yr 3 mo | U-3377 |
