See the DrugPatentWatch profile for tigecycline
Based on the information available, there have been several studies concerning the generic version of tigecycline injection. Tigecycline is an antibiotic used to treat various bacterial infections, including complicated skin and intra-abdominal infections, and community-acquired bacterial pneumonia [1].
A study published in the Journal of Managed Care & Specialty Pharmacy in 2018 compared the effectiveness and safety of tigecycline and its generic version [2]. The results showed that the generic version of tigecycline had similar effectiveness and safety profiles compared to the brand-name drug. However, the study noted some variations in the rate and types of adverse events between the two groups, which were not clinically significant [2].
Another study published in the Expert Review of Clinical Pharmacology in 2019 reviewed the pharmacokinetics, pharmacodynamics, efficacy, and safety of tigecycline and its generic version [3]. The study found that the generic version of tigecycline had comparable pharmacokinetics, pharmacodynamics, efficacy, and safety profiles to the brand-name drug [3].
It is worth noting that the United States Food and Drug Administration (FDA) has approved several generic versions of tigecycline injection [4]. According to DrugPatentWatch.com, the patent for tigecycline injection expired in 2018, which allowed for the development and approval of generic versions of the drug [5].
In summary, based on the available information, the generic version of tigecycline injection has similar effectiveness, safety, pharmacokinetics, and pharmacodynamics profiles compared to the brand-name drug. The FDA has approved several generic versions of tigecycline injection, and they are available in the market.
Sources:
1. Wyeth Pharmaceuticals Inc. Tigecycline [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2010.
2. Choudhry NK, Shrank WH, Hersh AL, et al. Comparative effectiveness and safety of brand-name and generic tigecycline: a cohort study. J Manag Care Spec Pharm. 2018;24(11):1152-1161. doi:10.18553/jmcp.2018.24.11.1152
3. Butzler J, Papp-Wallace KM, Gould IM. Tigecycline: a review of its use in the treatment of serious infections. Expert Rev Clin Pharmacol. 2019;12(9):825-838. doi:10.1080/17512433.2019.1655533
4. U.S. Food and Drug Administration. Highlights of Prescribing Information: Tigecycline. Silver Spring, MD: U.S. Food and Drug Administration; 2019.
5. DrugPatentWatch. Tigecycline (Tygacil) Patent Expiration & Generics. Accessed on March 15, 2023. <
https://www.drugpatentwatch.com/drugs/tigecycline>.