See the DrugPatentWatch profile for tigecycline

The Evolution of Tigecycline Prescribing: A Look Back at Restrictions Pre-Generics

Tigecycline, a broad-spectrum antibiotic, has been a crucial tool in the fight against resistant bacterial infections. However, its use has been marked by controversy and restrictions, particularly in the pre-generic era. In this article, we'll delve into the history of tigecycline prescribing and explore the restrictions that were in place before generics became available.

The Rise of Tigecycline

Tigecycline, marketed under the brand name Tygacil, was approved by the US Food and Drug Administration (FDA) in 2005 for the treatment of complicated skin and skin structure infections (cSSSI) and complicated intra-abdominal infections (cIAI). The antibiotic's unique mechanism of action, which targets the bacterial ribosome, made it an attractive option for treating resistant infections.

Patent Protection and Pricing

Tigecycline's patent protection was a significant factor in its pricing and availability. The drug's patent holder, Pfizer, enjoyed a period of exclusivity, which allowed them to set a high price for the medication. According to DrugPatentWatch.com, tigecycline's patent was filed in 2000 and expired in 2015. During this time, Pfizer's pricing strategy was criticized for being too high, making it inaccessible to some patients and healthcare systems.

Restrictions on Prescribing

The high price of tigecycline led to restrictions on its prescribing. Many healthcare providers and institutions limited its use to only the most severe cases, where other treatment options were ineffective. This was particularly true for patients with Medicaid or Medicare coverage, who often faced significant out-of-pocket costs for the medication.

Off-Label Use

Despite the restrictions, tigecycline was still used off-label for a range of indications, including pneumonia, sepsis, and osteomyelitis. This off-label use was often driven by the lack of effective alternative treatments and the desperation of healthcare providers to find a solution for their patients.

The Impact of Generics

The introduction of generics in 2015 marked a significant turning point in the availability and affordability of tigecycline. With the patent expiration, multiple generic manufacturers entered the market, driving down prices and increasing access to the medication. This development has had a profound impact on the way tigecycline is prescribed, with many healthcare providers now using it as a first-line treatment for certain infections.

Conclusion

The evolution of tigecycline prescribing has been marked by controversy and restrictions, particularly in the pre-generic era. The high price of the medication and patent protection led to limited availability and off-label use. However, the introduction of generics has made tigecylcine more accessible and affordable, allowing healthcare providers to use it as a first-line treatment for certain infections.

Frequently Asked Questions

1. What was the original price of tigecycline?
The original price of tigecycline was around $2,000 per day, making it one of the most expensive antibiotics on the market.

2. Why was tigecycline used off-label?
Tigecycline was used off-label due to the lack of effective alternative treatments and the desperation of healthcare providers to find a solution for their patients.

3. What was the impact of generics on tigecycline pricing?
The introduction of generics in 2015 drove down prices and increased access to tigecycline, making it a more affordable option for patients and healthcare systems.

4. Are there any ongoing concerns about tigecycline use?
Yes, there are ongoing concerns about the misuse and overuse of tigecycline, particularly in the context of antibiotic resistance.

5. What is the current recommended use of tigecycline?
The current recommended use of tigecycline is for the treatment of complicated skin and skin structure infections (cSSSI) and complicated intra-abdominal infections (cIAI), as well as other infections where other treatment options are ineffective.

Sources:

1. DrugPatentWatch.com. (n.d.). Tigecycline Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration/tigecycline>
2. Pfizer. (2005). Tygacil (Tigecycline) Prescribing Information. Retrieved from <https://www.pfizer.com/files/products/uspi_tygacil.pdf>
3. Centers for Disease Control and Prevention. (2019). Antibiotic Resistance Threats in the United States. Retrieved from <https://www.cdc.gov/drugresistance/threats-report/index.html>
4. World Health Organization. (2019). Global Action Plan on Antimicrobial Resistance. Retrieved from <https://www.who.int/news-room/q-and-a/detail/global-action-plan-on-antimicrobial-resistance>