Orange Book product · Brand (NDA)
RYZUMVI
PHENTOLAMINE MESYLATE
At a glance
Sep 25, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 2023
2 yr 9 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Sep 25, 2026
in 3 mo
Patent 10278918 expires
Listed drug product patent expiration.
Jan 31, 2034
in 7 yr 9 mo
Patent 10772829 expires
Listed drug product patent expiration.
Jan 31, 2034
in 7 yr 9 mo
Patent 11090261 expires
Listed drug product patent expiration.
Jan 31, 2034
in 7 yr 9 mo
Patent 11844858 expires
Listed drug product patent expiration.
Jan 31, 2034
in 7 yr 9 mo
Patent 12350366 expires
Listed drug product patent expiration.
Jan 31, 2034
in 7 yr 9 mo
Patent 9795560 expires
Listed drug product patent expiration.
Jan 31, 2034
in 7 yr 9 mo
Patent 11400077 expires
Listed method-of-use patent (U-3804) expiration.
Oct 25, 2039
in 13 yr 7 mo
Patent 12201615 expires
Listed method-of-use patent (U-3804) expiration.
Oct 25, 2039
in 13 yr 7 mo
Patent 12201616 expires
Listed method-of-use patent (U-3804) expiration.
Oct 25, 2039
in 13 yr 7 mo
Patent 12576066 expires
Listed method-of-use patent (U-3804) expiration.
Oct 25, 2039
in 13 yr 7 mo
Patent 12576067 expires
Listed method-of-use patent (U-3804) expiration.
Oct 25, 2039
in 13 yr 7 mo
Pharmaceutical detail
Active ingredient
PHENTOLAMINE MESYLATE
Strength
EQ 0.75% BASE
Dosage form
SOLUTION
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 217064
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)
- NPNew product exclusivity (3 years)
Sep 25, 2026
in 3 mo
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10278918 | Jan 31, 2034 | in 7 yr 9 mo | Product |
| 10772829 | Jan 31, 2034 | in 7 yr 9 mo | Product |
| 11090261 | Jan 31, 2034 | in 7 yr 9 mo | Product |
| 11844858 | Jan 31, 2034 | in 7 yr 9 mo | Product |
| 12350366 | Jan 31, 2034 | in 7 yr 9 mo | Product |
| 9795560 | Jan 31, 2034 | in 7 yr 9 mo | Product |
| 11400077 | Oct 25, 2039 | in 13 yr 7 mo | U-3804 |
| 12201615 | Oct 25, 2039 | in 13 yr 7 mo | U-3804 |
| 12201616 | Oct 25, 2039 | in 13 yr 7 mo | U-3804 |
| 12576066 | Oct 25, 2039 | in 13 yr 7 mo | U-3804 |
| 12576067 | Oct 25, 2039 | in 13 yr 7 mo | U-3804 |
