Orange Book product · Brand (NDA)
VTAMA
TAPINAROF
At a glance
May 23, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 23, 2022
4 yr 2 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 23, 2027
in 11 mo
Exclusivity ends · I-956
New indication exclusivity (3 years)
Dec 12, 2027
in 1 yr 6 mo
Patent 10426743 expires
Listed method-of-use patent (U-4048) expiration.
May 19, 2036
in 10 yr 1 mo
Patent 10426743 expires
Listed method-of-use patent (U-2625) expiration.
May 19, 2036
in 10 yr 1 mo
Patent 11458108 expires
Listed drug product patent expiration.
May 19, 2036
in 10 yr 1 mo
Patent 11612573 expires
Listed method-of-use patent (U-4048) expiration.
May 19, 2036
in 10 yr 1 mo
Patent 11612573 expires
Listed method-of-use patent (U-2625) expiration.
May 19, 2036
in 10 yr 1 mo
Patent 11617724 expires
Listed drug product patent expiration.
May 19, 2036
in 10 yr 1 mo
Patent 11622945 expires
Listed drug product patent expiration.
May 19, 2036
in 10 yr 1 mo
Patent 10195160 expires
Listed drug product patent expiration.
May 23, 2036
in 10 yr 1 mo
Patent 10647649 expires
Listed drug substance patent expiration.
Nov 13, 2038
in 12 yr 7 mo
Patent 11597692 expires
Listed drug substance patent expiration.
Nov 13, 2038
in 12 yr 7 mo
Patent 11497718 expires
Listed method-of-use patent (U-4048) expiration.
Nov 13, 2039
in 13 yr 7 mo
Patent 11590088 expires
Listed method-of-use patent (U-2625) expiration.
Nov 13, 2039
in 13 yr 7 mo
Patent 11938099 expires
Listed method-of-use patent (U-4048) expiration.
Nov 13, 2039
in 13 yr 7 mo
Patent 12569453 expires
Listed method-of-use patent (U-4048) expiration.
Dec 18, 2039
in 13 yr 8 mo
Pharmaceutical detail
Active ingredient
TAPINAROF
Strength
1%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 215272
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)
May 23, 2027
in 11 mo
- I-956New indication exclusivity (3 years)
Dec 12, 2027
in 1 yr 6 mo
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10426743 | May 19, 2036 | in 10 yr 1 mo | U-4048 |
| 10426743 | May 19, 2036 | in 10 yr 1 mo | U-2625 |
| 11458108 | May 19, 2036 | in 10 yr 1 mo | Product |
| 11612573 | May 19, 2036 | in 10 yr 1 mo | U-4048 |
| 11612573 | May 19, 2036 | in 10 yr 1 mo | U-2625 |
| 11617724 | May 19, 2036 | in 10 yr 1 mo | Product |
| 11622945 | May 19, 2036 | in 10 yr 1 mo | Product |
| 10195160 | May 23, 2036 | in 10 yr 1 mo | Product |
| 10647649 | Nov 13, 2038 | in 12 yr 7 mo | Substance |
| 11597692 | Nov 13, 2038 | in 12 yr 7 mo | SubstanceProduct |
| 11497718 | Nov 13, 2039 | in 13 yr 7 mo | U-4048 |
| 11590088 | Nov 13, 2039 | in 13 yr 7 mo | U-2625 |
| 11938099 | Nov 13, 2039 | in 13 yr 7 mo | U-4048 |
| 12569453 | Dec 18, 2039 | in 13 yr 8 mo | U-4048 |
