Orange Book product · Brand (NDA)
KYGEVVI
DOXECITINE; DOXRIBTIMINE
At a glance
Nov 03, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 03, 2025
8 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 03, 2030
in 4 yr 5 mo
Patent 10471087 expires
Listed method-of-use patent (U-4358) expiration.
Aug 07, 2036
in 10 yr 3 mo
Patent 11649259 expires
Listed drug product patent expiration.
Aug 19, 2040
in 14 yr 5 mo
Pharmaceutical detail
Active ingredient
DOXECITINE; DOXRIBTIMINE
Strength
2GM/PACKET;2GM/PACKET
Dosage form
FOR SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 219792
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.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Nov 03, 2030
in 4 yr 5 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10471087 | Aug 07, 2036 | in 10 yr 3 mo | U-4358 |
| 11649259 | Aug 19, 2040 | in 14 yr 5 mo | ProductU-4358 |
