FDA Orange Book
Generic for Omidria
Omidria contains phenylephrine and ketorolac. 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
Yes. The generic name for Omidria is phenylephrine and ketorolac. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Omidria products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, irrigation | EQ 0.3% BASE;EQ 1% BASE | Marketed (Rx) | AT | 1 | AT |
NDA 205388, held by RAYNER SURGICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic phenylephrine and ketorolac
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN LTD | 210183 | AT (A-rated, therapeutically equivalent) | July 1, 2019 | EQ 0.3% BASE;EQ 1% BASE |
Omidria patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9486406 | October 23, 2033 | Drug product | None | 205388 |
| 9066856 | October 23, 2033 | Drug product | None | 205388 |
| 9855246 | October 23, 2033 | Drug product | None | 205388 |
| 9066856*PED | April 23, 2034 | Method of use | None | 205388 |
| 9486406*PED | April 23, 2034 | Method of use | None | 205388 |
Omidria NDC codes
Questions
Is there a generic for Omidria?
Yes. The generic name for Omidria is phenylephrine and ketorolac. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Omidria?
The active ingredient in Omidria is phenylephrine and ketorolac, per the FDA Orange Book.
When does the Omidria patent expire?
The last patent listed for Omidria in the Orange Book expires April 23, 2034. 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.