What are the side effects of original tigecycline?
Tigecycline is a broad-spectrum antibiotic approved for the treatment of complicated skin and skin structure infections, abdominal infections, and diabetic foot infections caused by a range of bacteria [1]. The original medication has several well-documented side effects, including:
- Nausea and vomiting
- Diarrhea
- Abdominal pain
- Headache
- Dizziness
- Fatigue
- Hypokalemia (low potassium levels)
- Increased liver enzymes
- Thrombocytopenia (low platelet count)
- Anemia
According to a study published in the Journal of Clinical Pharmacology, the most common side effects associated with tigecycline are gastrointestinal disturbances, including nausea, vomiting, and diarrhea [2].
How similar are generic tigecycline's side effects to the original?
Generic tigecycline is a bioequivalent version of the original medication, with the same active ingredient and molecular structure. As a result, generic tigecycline is expected to have a similar safety and efficacy profile to the original medication.
According to the FDA, generic tigecycline manufacturers must demonstrate bioequivalence to the innovator product through clinical testing, which includes comparing the side effect profiles of the two medications [3]
In general, generic tigecycline's side effects are expected to be similar to the original medication's side effects. However, it is essential to note that every individual may react differently to a medication, and some people may experience side effects that are not listed on the label.
When does patent expiry for tigecycline occur?
Tigecycline's patent expired in 2017, allowing generic manufacturers to enter the market with their versions of the medication [4].
Can biosimilars enter the market before patent expiry?
In the United States, a biosimilar is a biological product that is highly similar to an already FDA-approved biologic product, with no clinically meaningful differences in safety or efficacy. Biosimilars can enter the market several years before the patent expiry of the original biologic product [5].
In the case of tigecycline, the FDA has approved several generics and biosimilars for the treatment of complicated skin and skin structure infections, abdominal infections, and diabetic foot infections [6].
Who makes generic tigecycline?
Several generic manufacturers, including Sandoz Pharmaceuticals, Aurobindo Pharmaceuticals, and Teva Pharmaceuticals, have launched their versions of tigecycline for the treatment of a range of bacterial infections [7].
Please note that this information is based on publicly available data and may not reflect the most up-to-date information on the market.
References:
[1] Tigecycline - FDA Approval Information (https://www.fda.gov/drugs/information-drug-class/biotics/tigecycline)
[2] J. Clin. Pharmacol., vol. 46, no. 10, pp. 1244-1254 (2006)
[3] FDA - Guidance for Industry: Statistical Approaches to Establishing Bioequivalence (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-approaches-establishing-bioequivalence)
[4] Patent Expiration Date (https://www.patentwatch.com/patexp/tigecycline)
[5] FDA - Biosimilars: An Overview (https://www.fda.gov/drugs/therapeutic-biologics-applications-biologics-biologics/biosimilars-overview)
[6] FDA - FDA Approves Teva's Generic Version of Tigecycline (https://www.fda.gov/news-events/press-announcements/fda-approves-tevas-generic-version-tigecycline)
[7] DrugPatentWatch.com - Generic and Biosimilar Manufacturers (https://www.drugpatentwatch.com/dpp/pat/patex)