Orange Book product · Brand (NDA)
VIVJOA
OTESECONAZOLE
At a glance
Apr 26, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 26, 2022
4 yr 3 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Apr 26, 2027
in 10 mo
Patent 8236962 expires
Listed drug substance patent expiration.
Apr 22, 2031
in 4 yr 11 mo
Patent 8754227 expires
Listed method-of-use patent (U-3366) expiration.
Apr 22, 2031
in 4 yr 11 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Apr 26, 2032
in 5 yr 11 mo
Patent 11247981 expires
Listed method-of-use patent (U-3366) expiration.
May 09, 2033
in 7 yr
Patent 10414751 expires
Listed drug substance patent expiration.
Mar 17, 2036
in 9 yr 11 mo
Patent 9840492 expires
Listed drug substance patent expiration.
Mar 17, 2036
in 9 yr 11 mo
Pharmaceutical detail
Active ingredient
OTESECONAZOLE
Strength
150MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 215888
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 (2)
- NCENew chemical entity exclusivity (5 years)
Apr 26, 2027
in 10 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
Apr 26, 2032
in 5 yr 11 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8236962 | Apr 22, 2031 | in 4 yr 11 mo | SubstanceProduct |
| 8754227 | Apr 22, 2031 | in 4 yr 11 mo | U-3366 |
| 11247981 | May 09, 2033 | in 7 yr | U-3366 |
| 10414751 | Mar 17, 2036 | in 9 yr 11 mo | SubstanceProduct |
| 9840492 | Mar 17, 2036 | in 9 yr 11 mo | SubstanceProduct |
