FDA Orange Book
Is there a generic for Tavneos?
Tavneos contains avacopan. 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 Tavneos (avacopan). The Orange Book shows its last listed patent expires November 27, 2039 and its last listed exclusivity ends October 7, 2028.
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Tavneos products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Marketed (Rx) | None | 0 | None |
NDA 214487, held by CHEMOCENTRYX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tavneos patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8445515 | February 3, 2031 | Drug substance, Drug product | None | 214487 |
| 8906938 | January 6, 2034 | Drug substance, Drug product | None | 214487 |
| 11603356 | November 27, 2039 | Drug substance, Drug product | U-3558 | 214487 |
| 11951214 | November 27, 2039 | Drug product | None | 214487 |
Tavneos exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | October 7, 2026 | 214487 |
| ODE-377 | Orphan drug exclusivity | October 7, 2028 | 214487 |
Tavneos NDC codes
Questions
Is there a generic for Tavneos?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tavneos (avacopan). The Orange Book shows its last listed patent expires November 27, 2039 and its last listed exclusivity ends October 7, 2028.
What is the generic name for Tavneos?
The active ingredient in Tavneos is avacopan, per the FDA Orange Book.
When does the Tavneos patent expire?
The last patent listed for Tavneos in the Orange Book expires November 27, 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.