Orange Book product · Brand (NDA)
UPNEEQ
OXYMETAZOLINE HYDROCHLORIDE
At a glance
Jul 08, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 08, 2020
6 yr ago
Today
Patent 10912765 expires
Listed method-of-use patent (U-2849) expiration.
Aug 26, 2031
in 5 yr 3 mo
Patent 8357714 expires
Listed method-of-use patent (U-2849) expiration.
Aug 26, 2031
in 5 yr 3 mo
Patent 9867808 expires
Listed method-of-use patent (U-2849) expiration.
Aug 26, 2031
in 5 yr 3 mo
Patent 10799481 expires
Listed method-of-use patent (U-2849) expiration.
Dec 16, 2039
in 13 yr 8 mo
Patent 10814001 expires
Listed drug product patent expiration.
Dec 16, 2039
in 13 yr 8 mo
Patent 10898573 expires
Listed drug product patent expiration.
Dec 16, 2039
in 13 yr 8 mo
Patent 10940138 expires
Listed method-of-use patent (U-2849) expiration.
Dec 16, 2039
in 13 yr 8 mo
Patent 11103482 expires
Listed drug product patent expiration.
Dec 16, 2039
in 13 yr 8 mo
Patent 11311515 expires
Listed drug product patent expiration.
Dec 16, 2039
in 13 yr 8 mo
Patent 11324722 expires
Listed method-of-use patent (U-2849) expiration.
Dec 16, 2039
in 13 yr 8 mo
Patent 11541036 expires
Listed drug product patent expiration.
Dec 16, 2039
in 13 yr 8 mo
Patent 11701343 expires
Listed method-of-use patent (U-2849) expiration.
Dec 16, 2039
in 13 yr 8 mo
Patent 12605363 expires
Listed drug product patent expiration.
Dec 16, 2039
in 13 yr 8 mo
Pharmaceutical detail
Active ingredient
OXYMETAZOLINE HYDROCHLORIDE
Strength
0.1%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 212520
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 (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10912765 | Aug 26, 2031 | in 5 yr 3 mo | U-2849 |
| 8357714 | Aug 26, 2031 | in 5 yr 3 mo | U-2849 |
| 9867808 | Aug 26, 2031 | in 5 yr 3 mo | U-2849 |
| 10799481 | Dec 16, 2039 | in 13 yr 8 mo | U-2849 |
| 10814001 | Dec 16, 2039 | in 13 yr 8 mo | Product |
| 10898573 | Dec 16, 2039 | in 13 yr 8 mo | Product |
| 10940138 | Dec 16, 2039 | in 13 yr 8 mo | U-2849 |
| 11103482 | Dec 16, 2039 | in 13 yr 8 mo | Product |
| 11311515 | Dec 16, 2039 | in 13 yr 8 mo | Product |
| 11324722 | Dec 16, 2039 | in 13 yr 8 mo | U-2849 |
| 11541036 | Dec 16, 2039 | in 13 yr 8 mo | Product |
| 11701343 | Dec 16, 2039 | in 13 yr 8 mo | U-2849 |
| 12605363 | Dec 16, 2039 | in 13 yr 8 mo | Product |
