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See the DrugPatentWatch profile for tigecycline
Tigecycline is a glycylcycline antibiotic derived from tetracycline. It binds to the bacterial ribosome to block protein synthesis and shows broad activity against anaerobes, including Bacteroides fragilis. How does tigecycline perform alone against B. fragilis? Tigecycline shows good in vitro activity against B. fragilis with MIC90 values mostly between 2–8 mg/L. In clinical trials it achieved eradication rates of 78–92% in intra-abdominal infections involving anaerobes. In mixed infections, mixed success rates reflect the complexity of polymicrobial disease rather than failure against B. fragilis itself. Why do clinicians combine tigecycline with other drugs? Tigecycline lacks reliable activity against Pseudomonas and some Proteus species. To cover these gaps, doctors add a antipseudomonal beta-lactam such as piperacillin-tazobactam or a pseudomonas-active cephalosporin. Combination regimens achieve 90–95% overall clinical cure rates in published series, but specific eradication rates for B. fragilis are not separately reported. What happens when tigecycline is used with beta-lactams versus quinolones? Tigecycline combined with beta-lactams shows no in vitro synergy or antagonism against B. fragilis. With quinolones such as moxifloxacin, in vitro data show variable results ranging from indifference to low-rate synergy. Clinical outcome data in B. fragilis infections are scarce. Can biosimilars or generic versions affect eradication rates? No biosimilars exist for tigecycline yet. Generics entered the U.S. market after the original patent expired in 2019. The generic formulations meet bioequivalence standards and deliver the same active ingredient, so eradication performance against B. fragils remains unchanged. When does the tigecycline patent expire? The original composition-of-matter patent for tigecycline expired in 2019. The drug has multiple secondary patents on formulations and salt forms that extend until 2024–2025 in some jurisdictions. When does exclusivity expire? Regulatory exclusivity periods for tigecycline have already expired. Who manufactures tigecycline? Tigecycline is made by Pfizer under the brand name Tygacil.
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