FDA Orange Book · active-ingredient family
Omidenepag isopropyl
Omidenepag isopropyl is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:OMLONTI · NDA 215092
1
Brand (NDA)
0
Generics (ANDA)
13
Listed patents
1
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OMLONTIRLD | OCUVEX THERAP | NDA 215092 | — | Sep 22, 2022 |
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Sep 22, 2027
in 1 yr 3 mo
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8648097 | Oct 13, 2029 | in 3 yr 4 mo | SubstanceProduct |
| 8685986 | Oct 13, 2029 | in 3 yr 4 mo | Product |
| 12295946 | Jan 08, 2035 | in 8 yr 8 mo | ProductU-3454 |
| 11197849 | Jan 08, 2035 | in 8 yr 8 mo | ProductU-3454 |
| 10702511 | Jan 08, 2035 | in 8 yr 8 mo | ProductU-3454 |
| 10179127 | Jan 08, 2035 | in 8 yr 8 mo | ProductU-3454 |
| 9415038 | Jan 08, 2035 | in 8 yr 8 mo | ProductU-3454 |
| RE48183 | Jan 08, 2035 | in 8 yr 8 mo | ProductU-3454 |
| 11793798 | Jan 08, 2035 | in 8 yr 8 mo | ProductU-3454 |
| 10765750 | Jan 08, 2035 | in 8 yr 8 mo | Product |
| 10774072 | Jun 10, 2035 | in 9 yr 1 mo | Substance |
| 12290511 | Dec 27, 2038 | in 12 yr 8 mo | U-3454 |
| 11666563 | Jul 16, 2039 | in 13 yr 3 mo | U-3454 |
Omidenepag isopropyl — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
