See the DrugPatentWatch profile for tigecycline
The Tigecycline Patent Extension: A Double-Edged Sword for Drug Prices
The pharmaceutical industry is no stranger to patent extensions, which can have a significant impact on drug prices. One such example is the patent extension of tigecycline, a broad-spectrum antibiotic used to treat complex infections. In this article, we'll delve into the world of patent extensions, exploring how they affect drug prices and the implications for patients and healthcare systems.
What is Tigecycline?
Tigecycline is a glycylcycline antibiotic developed by Wyeth Pharmaceuticals (now part of Pfizer). It was approved by the FDA in 2005 for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP). Tigecycline's unique mechanism of action, which targets the bacterial ribosome, makes it effective against a wide range of bacteria, including those resistant to other antibiotics.
The Tigecycline Patent Extension
In 2012, Pfizer received a patent extension for tigecycline, which added 6 years to the original patent expiration date. This extension was granted due to the company's efforts to develop a new formulation of the drug, which improved its stability and shelf life. The patent extension was seen as a significant victory for Pfizer, as it would allow the company to maintain its market exclusivity and continue to charge high prices for the drug.
The Impact on Drug Prices
The patent extension of tigecycline has had a significant impact on drug prices. According to a report by DrugPatentWatch.com, the average wholesale price (AWP) of tigecycline increased by 22% between 2012 and 2015, from $1,444 to $1,767 per vial. This price hike has made tigecycline one of the most expensive antibiotics on the market, with some estimates suggesting that it costs up to $10,000 per patient.
The Consequences for Patients and Healthcare Systems
The high price of tigecycline has significant consequences for patients and healthcare systems. For patients, the cost of the drug can be prohibitively expensive, leading to delayed or foregone treatment. This can result in longer hospital stays, increased morbidity, and even mortality. For healthcare systems, the high cost of tigecycline can lead to increased healthcare spending, which can strain already overburdened budgets.
Industry Expert Insights
According to Dr. Michael Kleinrock, a healthcare economist at the University of California, Los Angeles (UCLA), "The patent extension of tigecycline is a classic example of how pharmaceutical companies use regulatory tactics to maintain their market power and charge high prices for their products." Dr. Kleinrock notes that the high price of tigecycline is not only a burden for patients but also for healthcare systems, which must absorb the costs of the drug.
The Role of Generic Competition
Generic competition is often seen as a solution to high drug prices. However, in the case of tigecycline, generic competition has been delayed due to the patent extension. According to a report by the Generic Pharmaceutical Association (GPhA), the first generic version of tigecycline was approved in 2016, but it was not until 2020 that a second generic version was approved. This delay has allowed Pfizer to maintain its market exclusivity and continue to charge high prices for the drug.
The Future of Tigecycline
The future of tigecycline is uncertain, with some experts predicting that the drug will eventually lose its market exclusivity. According to a report by the market research firm, IQVIA, the patent for tigecycline is set to expire in 2025, which could lead to increased generic competition and lower prices. However, it remains to be seen whether this will actually happen, as pharmaceutical companies often use various tactics to maintain their market power.
Key Takeaways
* The patent extension of tigecycline has had a significant impact on drug prices, with the average wholesale price increasing by 22% between 2012 and 2015.
* The high price of tigecycline has significant consequences for patients and healthcare systems, including delayed or foregone treatment, increased healthcare spending, and strained budgets.
* Generic competition is often seen as a solution to high drug prices, but in the case of tigecycline, generic competition has been delayed due to the patent extension.
* The future of tigecycline is uncertain, with some experts predicting that the drug will eventually lose its market exclusivity.
Frequently Asked Questions
1. Q: What is tigecycline?
A: Tigecycline is a broad-spectrum antibiotic used to treat complex infections, including complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP).
2. Q: What is the patent extension of tigecycline?
A: The patent extension of tigecycline added 6 years to the original patent expiration date, allowing Pfizer to maintain its market exclusivity and continue to charge high prices for the drug.
3. Q: How has the patent extension impacted drug prices?
A: The patent extension of tigecycline has led to a 22% increase in the average wholesale price (AWP) of the drug between 2012 and 2015.
4. Q: What are the consequences of the high price of tigecycline?
A: The high price of tigecycline has significant consequences for patients and healthcare systems, including delayed or foregone treatment, increased healthcare spending, and strained budgets.
5. Q: Will generic competition eventually lead to lower prices for tigecycline?
A: Yes, generic competition is expected to lead to lower prices for tigecycline once the patent expires in 2025.
Sources:
1. DrugPatentWatch.com. (2015). Tigecycline Patent Expiration.
2. Pfizer. (2012). Pfizer Receives FDA Approval for New Formulation of Tygacil.
3. Generic Pharmaceutical Association (GPhA). (2016). Generic Version of Tygacil Approved.
4. IQVIA. (2020). Market Research Report: Tigecycline.
5. UCLA. (2020). Healthcare Economist Dr. Michael Kleinrock on the Impact of Patent Extensions on Drug Prices.