FDA Orange Book
Is there a generic for Sirturo?
Sirturo contains bedaquiline. 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 Sirturo (bedaquiline). The Orange Book shows its last listed patent expires March 19, 2029 and its last listed exclusivity ends July 28, 2028.
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Sirturo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
NDA 204384, held by JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Sirturo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7498343 | December 1, 2026 | Drug substance, Drug product | U-1321 | 204384 |
| 8546428 | March 19, 2029 | Drug substance, Drug product | U-1321 | 204384 |
Sirturo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE* | See the Orange Book exclusivity code list | August 9, 2026 | 204384 |
| ODE-251 | Orphan drug exclusivity | August 9, 2026 | 204384 |
| ODE-307 | Orphan drug exclusivity | May 27, 2027 | 204384 |
| M-306 | Miscellaneous | June 21, 2027 | 204384 |
| NPP | New patient population | July 28, 2028 | 204384 |
Sirturo NDC codes
Questions
Is there a generic for Sirturo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sirturo (bedaquiline). The Orange Book shows its last listed patent expires March 19, 2029 and its last listed exclusivity ends July 28, 2028.
What is the generic name for Sirturo?
The active ingredient in Sirturo is bedaquiline, per the FDA Orange Book.
When does the Sirturo patent expire?
The last patent listed for Sirturo in the Orange Book expires March 19, 2029. 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.