FDA Orange Book
Is there a generic for Sinuva?
Sinuva contains mometasone furoate. 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 Sinuva (mometasone furoate). The Orange Book shows its last listed patent expires November 24, 2034.
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Sinuva products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| implant, implantation | 1.35MG | Marketed (Rx) | None | 0 | None |
NDA 209310, held by INTERSECT ENT INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Sinuva patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9585681 | April 4, 2026 | Method of use | U-2272 | 209310 |
| 7544192 | November 29, 2026 | Method of use | U-2272 | 209310 |
| 8025635 | June 12, 2027 | Drug product | U-2272 | 209310 |
| 10357640 | October 3, 2031 | Method of use | U-2272 | 209310 |
| 8763222 | February 8, 2032 | Drug product | None | 209310 |
| 10406332 | March 13, 2034 | Drug product | None | 209310 |
| 10232152 | November 24, 2034 | Drug product | U-2272 | 209310 |
Sinuva NDC codes
Questions
Is there a generic for Sinuva?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sinuva (mometasone furoate). The Orange Book shows its last listed patent expires November 24, 2034.
What is the generic name for Sinuva?
The active ingredient in Sinuva is mometasone furoate, per the FDA Orange Book.
When does the Sinuva patent expire?
The last patent listed for Sinuva in the Orange Book expires November 24, 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.
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