Orange Book product · Brand (NDA)
RHOFADE
OXYMETAZOLINE HYDROCHLORIDE
At a glance
Jan 18, 2017
Approved
Brand (NDA)
Application
AB
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 18, 2017
9 yr 7 mo ago
Today
Patent 7812049 expires
Listed method-of-use patent (U-1959) expiration.
May 02, 2028
in 1 yr 11 mo
Patent 8883838 expires
Listed drug product patent expiration.
Dec 01, 2031
in 5 yr 6 mo
Patent 10335391 expires
Listed method-of-use patent (U-2567) expiration.
Jun 11, 2035
in 9 yr 1 mo
Patent 10751325 expires
Listed method-of-use patent (U-2921) expiration.
Jun 11, 2035
in 9 yr 1 mo
Patent 11517560 expires
Listed method-of-use patent (U-3494) expiration.
Jun 11, 2035
in 9 yr 1 mo
Patent 12350255 expires
Listed method-of-use patent (U-3494) expiration.
Jun 11, 2035
in 9 yr 1 mo
Patent 9974773 expires
Listed method-of-use patent (U-2306) expiration.
Jun 11, 2035
in 9 yr 1 mo
Pharmaceutical detail
Active ingredient
OXYMETAZOLINE HYDROCHLORIDE
Strength
1%
Dosage form
CREAM
Route
TOPICAL
TE code
AB
Application
NDA 208552
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 (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7812049 | May 02, 2028 | in 1 yr 11 mo | U-1959 |
| 8883838 | Dec 01, 2031 | in 5 yr 6 mo | Product |
| 10335391 | Jun 11, 2035 | in 9 yr 1 mo | U-2567 |
| 10751325 | Jun 11, 2035 | in 9 yr 1 mo | U-2921 |
| 11517560 | Jun 11, 2035 | in 9 yr 1 mo | U-3494 |
| 12350255 | Jun 11, 2035 | in 9 yr 1 mo | U-3494 |
| 9974773 | Jun 11, 2035 | in 9 yr 1 mo | U-2306 |
