FDA Orange Book
Is there a generic for Sivextro?
Sivextro contains tedizolid. 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 Sivextro (tedizolid). The Orange Book shows its last listed patent expires December 31, 2030 and its last listed exclusivity ends April 4, 2028.
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Sivextro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 200MG/VIAL | Marketed (Rx) | None | 0 | None |
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
NDA 205436, 205435, held by CUBIST PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Sivextro patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8420676 | February 23, 2028 | Drug substance, Drug product | U-282 | 205436 |
| 7816379 | June 20, 2028 | Drug substance, Drug product | U-2507 | 205436 |
| 9624250 | February 3, 2030 | Drug substance, Drug product | U-2507 | 205436 |
| 9988406 | February 3, 2030 | Drug product | None | 205436 |
| 10442829 | February 3, 2030 | Drug substance | None | 205436 |
| 10065947 | February 3, 2030 | Drug product | None | 205436 |
| 8426389 | December 31, 2030 | Drug substance, Drug product | U-282 | 205436 |
Sivextro exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | April 4, 2028 | 205436 |
Sivextro NDC codes
Questions
Is there a generic for Sivextro?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sivextro (tedizolid). The Orange Book shows its last listed patent expires December 31, 2030 and its last listed exclusivity ends April 4, 2028.
What is the generic name for Sivextro?
The active ingredient in Sivextro is tedizolid, per the FDA Orange Book.
When does the Sivextro patent expire?
The last patent listed for Sivextro in the Orange Book expires December 31, 2030. 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.