Is Sivextro Available as an Oral Tablet?
No, Sivextro (tedizolid phosphate) is not available as an oral tablet. It comes only as an intravenous (IV) infusion powder for reconstitution.[1]
What Forms Does Sivextro Come In?
Sivextro is approved solely as a 200 mg powder for IV infusion in single-use vials. It's administered once daily over 1 hour for treating acute bacterial skin and skin structure infections (ABSSSI) in adults.[1][2]
Why No Oral Tablet Option?
Tedizolid, the active metabolite, was originally developed with both IV and oral formulations in clinical trials, but the FDA approved only the IV version in 2014. The oral form (tablets) did not gain approval, likely due to manufacturing, stability, or efficacy data issues during review.[3] No oral version exists on the market today.
How Does This Compare to Similar Antibiotics?
Unlike Sivextro, competitors like linezolid (Zyvox) offer both IV and oral tablet forms, allowing step-down therapy from hospital to home. Tedizolid's IV-only limitation means patients often switch to alternatives post-hospitalization.[2][4]
When Might an Oral Version Become Available?
No oral Sivextro is in active development or pending FDA approval. Patents on the IV formulation extend into the late 2020s (e.g., U.S. Patent 8,557,804 expires 2027), with no listings for oral variants on DrugPatentWatch.[5] Generic or biosimilar IV entry could follow patent cliffs, but oral remains unlikely without new trials.
Sources
[1]: FDA Label for Sivextro
[2]: Drugs.com - Sivextro
[3]: FDA Approval History
[4]: Medscape - Tedizolid Overview
[5]: DrugPatentWatch.com - Sivextro Patents