Orange Book product · Brand (NDA)
MIEBO
PERFLUOROHEXYLOCTANE
At a glance
May 18, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 18, 2023
3 yr 2 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 18, 2028
in 1 yr 11 mo
Patent 10058615 expires
Listed method-of-use patent (U-1900) expiration.
Sep 12, 2033
in 7 yr 4 mo
Patent 10369117 expires
Listed method-of-use patent (U-1900) expiration.
Sep 12, 2033
in 7 yr 4 mo
Patent 10449164 expires
Listed method-of-use patent (U-1900) expiration.
Sep 12, 2033
in 7 yr 4 mo
Patent 10576154 expires
Listed method-of-use patent (U-1900) expiration.
Oct 01, 2035
in 9 yr 5 mo
Patent 11357738 expires
Listed drug product patent expiration.
Sep 29, 2036
in 10 yr 5 mo
Patent 10507132 expires
Listed method-of-use patent (U-1900) expiration.
Jun 21, 2037
in 11 yr 2 mo
Pharmaceutical detail
Active ingredient
PERFLUOROHEXYLOCTANE
Strength
1.338GM/ML
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 216675
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)
- NCENew chemical entity exclusivity (5 years)
May 18, 2028
in 1 yr 11 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10058615 | Sep 12, 2033 | in 7 yr 4 mo | U-1900 |
| 10369117 | Sep 12, 2033 | in 7 yr 4 mo | U-1900 |
| 10449164 | Sep 12, 2033 | in 7 yr 4 mo | U-1900 |
| 10576154 | Oct 01, 2035 | in 9 yr 5 mo | U-1900 |
| 11357738 | Sep 29, 2036 | in 10 yr 5 mo | Product |
| 10507132 | Jun 21, 2037 | in 11 yr 2 mo | U-1900 |
