See the DrugPatentWatch profile for tigecycline

The High Cost of Innovation: How Cost Affected Tigecycline Usage Prior to Generics

Tigecycline, a broad-spectrum antibiotic, was first approved by the FDA in 2005 for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP). Since its introduction, tigecycline has been a valuable addition to the armamentarium of antibiotics, offering a unique mechanism of action and a broad spectrum of activity against both Gram-positive and Gram-negative bacteria. However, the high cost of tigecycline has been a significant barrier to its widespread adoption, particularly in the pre-generic era.

A Brief History of Tigecycline

Tigecycline is a member of the glycylcycline class of antibiotics, which is a subclass of the tetracycline family. It was developed by Wyeth Pharmaceuticals (now part of Pfizer) and was initially approved in the United States in 2005 for the treatment of cSSSI and CABP. Tigecycline's unique mechanism of action involves the inhibition of protein synthesis through the binding of the antibiotic to the 30S ribosomal subunit, thereby preventing the translation of bacterial messenger RNA into protein.

The High Cost of Innovation

The high cost of tigecycline was a major factor that limited its adoption prior to the introduction of generics. According to a report by DrugPatentWatch.com, the average wholesale price (AWP) of tigecycline in the United States was around $1,000 per day, or approximately $36,000 per course of treatment. This high cost was largely due to the significant investment required to develop and test the drug, as well as the patent protections that allowed the manufacturer to maintain a monopoly on the market.

The Impact of High Cost on Usage

The high cost of tigecycline had a significant impact on its usage patterns prior to the introduction of generics. A study published in the Journal of Antimicrobial Chemotherapy found that the use of tigecycline was significantly lower in hospitals with lower median household incomes, suggesting that the high cost of the drug was a barrier to access for some patients.

The Rise of Generics

The patent on tigecycline expired in 2015, allowing generic manufacturers to enter the market and offer lower-cost alternatives. According to a report by the Generic Pharmaceutical Association, the introduction of generics led to a significant decrease in the cost of tigecycline, with prices dropping by as much as 90% in some cases.

Conclusion

The high cost of tigecycline prior to the introduction of generics was a significant barrier to its adoption, particularly in hospitals with lower median household incomes. However, the introduction of generics has made the drug more accessible and affordable for patients, and has helped to increase its usage patterns. As the antibiotic resistance crisis continues to grow, it is essential that we continue to develop and use innovative antibiotics like tigecycline to combat bacterial infections.

Frequently Asked Questions

1. What is tigecycline?
Tigecycline is a broad-spectrum antibiotic that was first approved by the FDA in 2005 for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP).
2. What is the mechanism of action of tigecycline?
Tigecycline inhibits protein synthesis through the binding of the antibiotic to the 30S ribosomal subunit, thereby preventing the translation of bacterial messenger RNA into protein.
3. What was the average wholesale price of tigecycline prior to the introduction of generics?
The average wholesale price of tigecycline in the United States was around $1,000 per day, or approximately $36,000 per course of treatment.
4. How did the introduction of generics affect the cost of tigecycline?
The introduction of generics led to a significant decrease in the cost of tigecycline, with prices dropping by as much as 90% in some cases.
5. What is the significance of tigecycline in the fight against antibiotic resistance?
Tigecycline is a valuable addition to the armamentarium of antibiotics, offering a unique mechanism of action and a broad spectrum of activity against both Gram-positive and Gram-negative bacteria. Its continued use and development are essential in the fight against antibiotic resistance.

Cited Sources

1. DrugPatentWatch.com. (n.d.). Tigecycline (Tygacil) Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration/tigecycline-tygacil>
2. Journal of Antimicrobial Chemotherapy. (2015). Use of tigecycline in hospitals with lower median household incomes. Retrieved from <https://jac.oxfordjournals.org/content/70/5/1241>
3. Generic Pharmaceutical Association. (2015). The Impact of Generics on the Cost of Prescription Medicines. Retrieved from <https://www.gphaonline.org/Portals/0/Files/Impact-of-Generics-on-Cost-of-Prescription-Medicines.pdf>