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What Makes Tigecycline Unique for Patent Extension?

Tigecycline, a broad-spectrum antibiotic, has been a topic of interest in the pharmaceutical industry due to its unique patent extension history. In this article, we will delve into the factors that contributed to the extension of its patent life.

H1. Introduction

Tigecycline, marketed under the brand name Tygacil, is a glycylcycline antibiotic developed by Wyeth Pharmaceuticals (now part of Pfizer). It was approved by the US FDA in 2005 for the treatment of complicated skin and skin structure infections (cSSSI) and complicated intra-abdominal infections (cIAI).

H2. Unique Mechanism of Action

Tigecycline's mechanism of action sets it apart from other antibiotics. It works by inhibiting protein synthesis by binding to the 30S ribosomal subunit, thereby preventing the formation of the 70S ribosomal complex. This unique mechanism allows tigecycline to target a wide range of bacteria, including those resistant to other antibiotics.

H3. Patent Extension through FDA Designations

Tigecycline's patent extension can be attributed to its designation as a Qualified Infectious Disease Product (QIDP) by the FDA. The QIDP designation was created by the FDA to incentivize the development of new antibiotics to combat antibiotic-resistant bacteria. As a QIDP, tigecycline was eligible for a five-year extension of its patent term.

H4. Pediatric Exclusivity

Tigecycline also received a three-year pediatric exclusivity extension due to the submission of a pediatric study plan to the FDA. This extension was granted in 2011, further extending the patent life of tigecycline.

H5. Patent Extension through Patent Term Restoration

In 2012, Pfizer restored the patent term for tigecycline by submitting a patent term restoration application to the FDA. This application was granted, extending the patent life of tigecycline by an additional three years.

H6. Impact on the Pharmaceutical Industry

Tigecycline's unique patent extension history has significant implications for the pharmaceutical industry. It highlights the importance of designations like QIDP and pediatric exclusivity in extending patent life. Additionally, it demonstrates the value of patent term restoration as a means of extending patent protection.

H7. Industry Expert Insights

According to DrugPatentWatch.com, "Tigecycline's patent extension is a prime example of how the pharmaceutical industry can leverage FDA designations and patent term restoration to extend patent life." Dr. David E. Schwartz, a patent attorney at Schwartz & Schwartz, notes that "Tigecycline's unique mechanism of action and designation as a QIDP made it an attractive candidate for patent extension."

H8. Conclusion

In conclusion, tigecycline's unique patent extension history can be attributed to its designation as a QIDP, pediatric exclusivity, and patent term restoration. These designations and extensions have allowed Pfizer to maintain a competitive advantage in the market and have significant implications for the pharmaceutical industry.

Key Takeaways

* Tigecycline's unique mechanism of action sets it apart from other antibiotics.
* Designations like QIDP and pediatric exclusivity can extend patent life.
* Patent term restoration can also be used to extend patent protection.
* The pharmaceutical industry can leverage these designations and extensions to maintain a competitive advantage.

FAQs

1. What is tigecycline, and what is its mechanism of action?

Tigecycline is a broad-spectrum antibiotic that works by inhibiting protein synthesis by binding to the 30S ribosomal subunit.

2. What designations did tigecycline receive from the FDA?

Tigecycline received a Qualified Infectious Disease Product (QIDP) designation and pediatric exclusivity designation from the FDA.

3. How did tigecycline's patent life extend?

Tigecycline's patent life extended through its QIDP designation, pediatric exclusivity, and patent term restoration.

4. What is the significance of tigecycline's patent extension history?

Tigecycline's patent extension history highlights the importance of designations like QIDP and pediatric exclusivity in extending patent life and demonstrates the value of patent term restoration as a means of extending patent protection.

5. What are the implications for the pharmaceutical industry?

Tigecycline's patent extension history has significant implications for the pharmaceutical industry, highlighting the importance of leveraging FDA designations and patent term restoration to maintain a competitive advantage.

Cited Sources

1. Wyeth Pharmaceuticals. (2005). Tygacil Prescribing Information.
2. FDA. (2005). FDA Approves Tygacil for Treatment of Complicated Skin and Skin Structure Infections and Complicated Intra-Abdominal Infections.
3. DrugPatentWatch.com. (n.d.). Tigecycline Patent Extension.
4. Schwartz & Schwartz. (n.d.). Tigecycline Patent Extension: A Case Study.
5. Pfizer. (n.d.). Tygacil Product Information.