FDA Orange Book
Is there a generic for Upneeq?
Upneeq contains oxymetazoline. 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 Upneeq (oxymetazoline). The Orange Book shows its last listed patent expires December 16, 2039.
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Upneeq products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.1% | Marketed (Rx) | None | 0 | None |
NDA 212520, held by RVL PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Upneeq patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8357714 | August 26, 2031 | Method of use | U-2849 | 212520 |
| 9867808 | August 26, 2031 | Method of use | U-2849 | 212520 |
| 10912765 | August 26, 2031 | Method of use | U-2849 | 212520 |
| 11324722 | December 16, 2039 | Method of use | U-2849 | 212520 |
| 10940138 | December 16, 2039 | Method of use | U-2849 | 212520 |
| 10799481 | December 16, 2039 | Method of use | U-2849 | 212520 |
| 11701343 | December 16, 2039 | Method of use | U-2849 | 212520 |
| 12648930 | December 16, 2039 | Method of use | U-2849 | 212520 |
| 10898573 | December 16, 2039 | Drug product | None | 212520 |
| 12605363 | December 16, 2039 | Drug product | None | 212520 |
| 10814001 | December 16, 2039 | Drug product | None | 212520 |
| 11311515 | December 16, 2039 | Drug product | None | 212520 |
| 11541036 | December 16, 2039 | Drug product | None | 212520 |
| 11103482 | December 16, 2039 | Drug product | None | 212520 |
Upneeq NDC codes
Questions
Is there a generic for Upneeq?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Upneeq (oxymetazoline). The Orange Book shows its last listed patent expires December 16, 2039.
What is the generic name for Upneeq?
The active ingredient in Upneeq is oxymetazoline, per the FDA Orange Book.
When does the Upneeq patent expire?
The last patent listed for Upneeq in the Orange Book expires December 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.