FDA Orange Book
Is there a generic for Tembexa?
Tembexa contains brincidofovir. 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 Tembexa (brincidofovir). The Orange Book shows its last listed patent expires October 10, 2034 and its last listed exclusivity ends June 4, 2028.
Run it in Rivvi
Map Tembexa 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.
Tembexa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 10MG/ML | Marketed (Rx) | None | 0 | None |
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
NDA 214460, 214461, held by EMERGENT BIODEFENSE OPERATIONS LANSING LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tembexa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9303051 | July 30, 2034 | Drug substance, Drug product | U-3165 | 214460 |
| 10112909 | October 10, 2034 | Method of use | U-3165 | 214461 |
| 10487061 | October 10, 2034 | Drug product | U-3165 | 214461 |
| 8962829 | October 10, 2034 | Drug substance, Drug product | None | 214461 |
| 9371344 | October 10, 2034 | Drug product | None | 214461 |
Tembexa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-354 | Orphan drug exclusivity | June 4, 2028 | 214460 |
Tembexa NDC codes
Questions
Is there a generic for Tembexa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tembexa (brincidofovir). The Orange Book shows its last listed patent expires October 10, 2034 and its last listed exclusivity ends June 4, 2028.
What is the generic name for Tembexa?
The active ingredient in Tembexa is brincidofovir, per the FDA Orange Book.
When does the Tembexa patent expire?
The last patent listed for Tembexa in the Orange Book expires October 10, 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.