FDA Orange Book
Is there a generic for Omlonti?
Omlonti contains omidenepag isopropyl. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Omlonti (omidenepag isopropyl). The Orange Book shows its last listed patent expires July 16, 2039 and its last listed exclusivity ends September 22, 2027.
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Omlonti products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, ophthalmic | 0.002% | Marketed (Rx) | None | 0 | None |
NDA 215092, held by OCUVEX THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Omlonti patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8648097 | October 13, 2029 | Drug substance, Drug product | None | 215092 |
| 8685986 | October 13, 2029 | Drug product | None | 215092 |
| 12295946 | January 8, 2035 | Drug product | U-3454 | 215092 |
| 11197849 | January 8, 2035 | Drug product | U-3454 | 215092 |
| 10702511 | January 8, 2035 | Drug product | U-3454 | 215092 |
| 10179127 | January 8, 2035 | Drug product | U-3454 | 215092 |
| 9415038 | January 8, 2035 | Drug product | U-3454 | 215092 |
| RE48183 | January 8, 2035 | Drug product | U-3454 | 215092 |
| 11793798 | January 8, 2035 | Drug product | U-3454 | 215092 |
| 10765750 | January 8, 2035 | Drug product | None | 215092 |
| 10774072 | June 10, 2035 | Drug substance | None | 215092 |
| 12290511 | December 27, 2038 | Method of use | U-3454 | 215092 |
| 11666563 | July 16, 2039 | Method of use | U-3454 | 215092 |
Omlonti exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 22, 2027 | 215092 |
Omlonti NDC codes
Questions
Is there a generic for Omlonti?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Omlonti (omidenepag isopropyl). The Orange Book shows its last listed patent expires July 16, 2039 and its last listed exclusivity ends September 22, 2027.
What is the generic name for Omlonti?
The active ingredient in Omlonti is omidenepag isopropyl, per the FDA Orange Book.
When does the Omlonti patent expire?
The last patent listed for Omlonti in the Orange Book expires July 16, 2039. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.