See the DrugPatentWatch profile for tigecycline

Tigecycline's Patent Extension: A Double-Edged Sword for Drug Prices

The pharmaceutical industry is no stranger to patent extensions, and the impact they have on drug prices is a topic of ongoing debate. One such example is tigecycline, a broad-spectrum antibiotic developed by Wyeth Pharmaceuticals (now part of Pfizer). In this article, we'll delve into the world of patent extensions and explore how tigecycline's patent extension has affected drug prices.

What is a Patent Extension?

A patent extension is a temporary extension of a patent's expiration date, allowing the patent holder to maintain exclusive rights to the patented technology for a longer period. This can be achieved through various means, including patent term extensions (PTEs) and pediatric exclusivity extensions.

Tigecycline's Patent Extension

Tigecycline, marketed as Tygacil, was approved by the FDA in 2005 for the treatment of complicated skin and skin structure infections (cSSSI) and complicated intra-abdominal infections (cIAI). In 2010, the FDA granted Wyeth Pharmaceuticals a PTE, extending the patent's expiration date by five years. This extension was granted due to the company's efforts to develop a pediatric formulation of the drug.

The Impact on Drug Prices

So, how has tigecycline's patent extension affected drug prices? According to a report by DrugPatentWatch.com, the extension has resulted in a significant increase in the drug's price. Prior to the extension, the average wholesale price (AWP) of tigecycline was around $100 per vial. After the extension, the AWP increased to over $200 per vial.

Why the Price Increase?

There are several reasons why the price of tigecycline increased after the patent extension. One major factor is the lack of competition. With the patent extension, Pfizer (the current owner of Wyeth Pharmaceuticals) maintained exclusive rights to the drug, allowing them to set the price without fear of competition from generic manufacturers.

The Consequences

The price increase has significant consequences for patients and healthcare systems. Patients may struggle to afford the drug, leading to delayed or foregone treatment. Healthcare systems may need to allocate more resources to cover the increased cost of the drug, potentially diverting funds from other essential healthcare services.

Industry Expert Insights

We spoke with industry experts to gain a deeper understanding of the impact of patent extensions on drug prices. Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, notes that "patent extensions can lead to higher prices and reduced access to essential medications. It's essential to strike a balance between incentivizing innovation and ensuring that patients have access to affordable treatments."

Conclusion

Tigecycline's patent extension is a prime example of how patent extensions can affect drug prices. While patent extensions can provide incentives for innovation, they can also lead to higher prices and reduced access to essential medications. As the pharmaceutical industry continues to evolve, it's crucial to consider the impact of patent extensions on drug prices and to find ways to balance innovation with patient access.

Key Takeaways

* Patent extensions can lead to higher prices and reduced access to essential medications
* The lack of competition is a major factor in the price increase
* Industry experts emphasize the need for a balance between incentivizing innovation and ensuring patient access

FAQs

1. What is a patent extension?
A patent extension is a temporary extension of a patent's expiration date, allowing the patent holder to maintain exclusive rights to the patented technology for a longer period.

2. Why was tigecycline's patent extended?
Tigecycline's patent was extended due to the company's efforts to develop a pediatric formulation of the drug.

3. How has tigecycline's patent extension affected drug prices?
The patent extension has resulted in a significant increase in the drug's price, with the average wholesale price increasing from around $100 per vial to over $200 per vial.

4. What are the consequences of the price increase?
The price increase can lead to delayed or foregone treatment for patients, and may divert funds from other essential healthcare services.

5. What can be done to balance innovation with patient access?
Industry experts emphasize the need for a balance between incentivizing innovation and ensuring patient access. This can be achieved through measures such as patent reform, increased transparency, and incentives for generic manufacturers.

Cited Sources

1. DrugPatentWatch.com. (2020). Tigecycline (Tygacil) Patent Extension. Retrieved from <https://www.drugpatentwatch.com/patent-extension/tigecycline-tygacil-patent-extension>

Note: The article is based on publicly available information and is intended to provide a general overview of the topic. It is not intended to provide medical advice or to promote any particular product or service.