FDA Orange Book
Is there a generic for Sernivo?
Sernivo contains betamethasone dipropionate. 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 Sernivo (betamethasone dipropionate). The Orange Book shows its last listed patent expires November 19, 2045.
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Sernivo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, topical | EQ 0.05% BASE/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 208079, held by PRIMUS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Sernivo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9775851 | August 31, 2030 | Drug product | U-1858 | 208079 |
| 9364485 | August 31, 2030 | Drug product | U-1858 | 208079 |
| 9655907 | August 31, 2030 | Drug product | U-1858 | 208079 |
| 10179137 | August 31, 2030 | Drug product | U-1858 | 208079 |
| 9433630 | August 31, 2030 | Drug product | U-1858 | 208079 |
| 9877974 | August 31, 2030 | Drug product | U-1858 | 208079 |
| 9439911 | August 31, 2030 | Drug product | U-1858 | 208079 |
| 12661489 | November 19, 2045 | Method of use | U-4596 | 208079 |
Sernivo NDC codes
Questions
Is there a generic for Sernivo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sernivo (betamethasone dipropionate). The Orange Book shows its last listed patent expires November 19, 2045.
What is the generic name for Sernivo?
The active ingredient in Sernivo is betamethasone dipropionate, per the FDA Orange Book.
When does the Sernivo patent expire?
The last patent listed for Sernivo in the Orange Book expires November 19, 2045. 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.
More on Sernivo and Betamethasone Dipropionate
- What is Betamethasone Dipropionate used for?FDA label uses
- Is Betamethasone Dipropionate a controlled substance?Federal schedule
- Generic for DiproleneFDA Orange Book
- Generic for Diprolene AfFDA Orange Book
- Generic for AlphatrexFDA Orange Book
- Generic for DiprosoneFDA Orange Book
- Corticosteroids listFDA drug class
- NDC 68040-714Sernivo NDC record