FDA Orange Book
Is there a generic for Inveltys?
Inveltys contains loteprednol etabonate. 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 Inveltys (loteprednol etabonate). The Orange Book shows its last listed patent expires May 3, 2033.
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Inveltys products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension/drops, ophthalmic | 1% | Marketed (Rx) | None | 0 | None |
NDA 210565, held by ALCON LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Inveltys patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9056057 | May 3, 2033 | Drug product | U-2491 | 210565 |
| 9532955 | May 3, 2033 | Method of use | U-2491 | 210565 |
| 10058511 | May 3, 2033 | Drug product | U-2492 | 210565 |
| 11219597 | May 3, 2033 | Method of use | U-3278 | 210565 |
| 11219597 | May 3, 2033 | Method of use | U-3279 | 210565 |
| 10864219 | May 3, 2033 | Method of use | U-3011 | 210565 |
| 9737491 | May 3, 2033 | Method of use | U-2492 | 210565 |
| 9827191 | May 3, 2033 | Drug product | U-2493 | 210565 |
| 12115246 | May 3, 2033 | Drug product | U-4025 | 210565 |
| 10688045 | May 3, 2033 | Drug product | None | 210565 |
| 11642317 | May 3, 2033 | Drug product | None | 210565 |
| 10646437 | May 3, 2033 | Drug product | None | 210565 |
| 9393213 | May 3, 2033 | Drug product | None | 210565 |
| 11872318 | May 3, 2033 | Drug product | None | 210565 |
Questions
Is there a generic for Inveltys?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Inveltys (loteprednol etabonate). The Orange Book shows its last listed patent expires May 3, 2033.
What is the generic name for Inveltys?
The active ingredient in Inveltys is loteprednol etabonate, per the FDA Orange Book.
When does the Inveltys patent expire?
The last patent listed for Inveltys in the Orange Book expires May 3, 2033. 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.