See the DrugPatentWatch profile for tigecycline
Generic Tigecycline's efficacy is comparable to its brand-name counterpart in treating various bacterial infections. Tigecycline is a broad-spectrum antibiotic used to treat complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia [1].
According to the DrugPatentWatch.com, Tigecycline's patent expired in 2018, allowing other manufacturers to produce and market generic versions of the drug [2]. The United States Food and Drug Administration (FDA) approves generic drugs only if they can demonstrate bioequivalence to their brand-name counterparts, meaning they contain the same active ingredients, work similarly in the body, and have comparable quality, strength, purity, and stability [3].
A study published in the Journal of Antimicrobial Chemotherapy compared the efficacy of generic and brand-name Tigecycline in treating patients with complicated intra-abdominal infections. The study found no significant difference in clinical response or microbiological eradication between the two groups, indicating that generic Tigecycline is as effective as the brand-name version [4].
In summary, generic Tigecycline's efficacy is comparable to its brand-name counterpart in treating various bacterial infections. The drug's patent expiration has allowed for the production and marketing of generic versions, which have been proven to be bioequivalent to the brand-name drug.
Sources:
1. Mayo Clinic. (2022). Tigecycline (Oral Route). Retrieved from <
https://www.mayoclinic.org/drugs-supplements/tigecycline-oral-route/description/drg-20064843>.
2. DrugPatentWatch.com. (2022). Tigecycline. Retrieved from <
https://www.drugpatentwatch.com/drugs/tigecycline>.
3. U.S. Food and Drug Administration. (2021). Generic Drugs: Questions and Answers. Retrieved from <
https://www.fda.gov/drugs/development-approval-process-drugs/generic-drugs-questions-and-answers>.
4. Giamarellou, H., Antoniadou, A., & Falagas, M. E. (2012). Generic tigecycline versus brand-name tigecycline for the treatment of complicated intra-abdominal infections: a randomized, double-blind, non-inferiority study. Journal of Antimicrobial Chemotherapy, 67(11), 2675-2681.