FDA Orange Book
Generic for Rhofade
Rhofade 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
Yes. The generic name for Rhofade is oxymetazoline. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Rhofade and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Rhofade products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 1% | Marketed (Rx) | AB | 1 | AB |
NDA 208552, held by MAYNE PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic oxymetazoline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 213584 | AB (A-rated, therapeutically equivalent) | October 4, 2021 | 1% |
Rhofade patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7812049 | May 2, 2028 | Method of use | U-1959 | 208552 |
| 8883838 | December 1, 2031 | Drug product | None | 208552 |
| 9974773 | June 11, 2035 | Method of use | U-2306 | 208552 |
| 10751325 | June 11, 2035 | Method of use | U-2921 | 208552 |
| 12350255 | June 11, 2035 | Method of use | U-3494 | 208552 |
| 10335391 | June 11, 2035 | Method of use | U-2567 | 208552 |
| 11517560 | June 11, 2035 | Method of use | U-3494 | 208552 |
Rhofade NDC codes
Questions
Is there a generic for Rhofade?
Yes. The generic name for Rhofade is oxymetazoline. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Rhofade?
The active ingredient in Rhofade is oxymetazoline, per the FDA Orange Book.
When does the Rhofade patent expire?
The last patent listed for Rhofade in the Orange Book expires June 11, 2035. 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.