Orange Book product · Brand (NDA)
TPOXX
TECOVIRIMAT
At a glance
Jul 13, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 13, 2018
8 yr 1 mo ago
Today
Patent 8039504 expires
Listed drug product patent expiration.
Jul 23, 2027
in 1 yr 1 mo
Patent 12433868 expires
Listed drug product patent expiration.
Mar 23, 2031
in 4 yr 10 mo
Patent 9339466 expires
Listed drug substance patent expiration.
Mar 23, 2031
in 4 yr 10 mo
Patent 7737168 expires
Listed method-of-use patent (U-2346) expiration.
Sep 04, 2031
in 5 yr 3 mo
Patent 11890270 expires
Listed method-of-use patent (U-2346) expiration.
Aug 08, 2032
in 6 yr 3 mo
Pharmaceutical detail
Active ingredient
TECOVIRIMAT
Strength
200MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 208627
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 |
| 12433868 | Mar 23, 2031 | in 4 yr 10 mo | Product |
| 9339466 | Mar 23, 2031 | in 4 yr 10 mo | SubstanceProduct |
| 7737168 | Sep 04, 2031 | in 5 yr 3 mo | U-2346 |
| 11890270 | Aug 08, 2032 | in 6 yr 3 mo | U-2346 |
