See the DrugPatentWatch profile for tigecycline

Tigecycline for Injection: A Comprehensive Overview of the Patent and Its Impact on the Pharmaceutical Industry

Tigecycline, a broad-spectrum antibiotic, has been a game-changer in the treatment of severe infections. Its injectable form has been a subject of interest for many pharmaceutical companies and researchers. In this article, we will delve into the patent of tigecycline for injection, its history, and its impact on the pharmaceutical industry.

What is Tigecycline?

Tigecycline is a glycylcycline antibiotic that was first approved by the US FDA in 2005. It is a semi-synthetic derivative of minocycline, a tetracycline antibiotic. Tigecycline works by inhibiting the protein synthesis of bacteria, thereby preventing them from growing and multiplying.

Patent History of Tigecycline for Injection

The patent for tigecycline for injection was filed by Wyeth Pharmaceuticals (now part of Pfizer) in 2001. The patent was granted in 2005 and was set to expire in 2020. However, due to the patent term extension granted by the US FDA, the patent was extended until 2025.

Key Features of the Patent

The patent for tigecycline for injection covers the use of the antibiotic in the treatment of severe infections, including pneumonia, sepsis, and intra-abdominal infections. The patent also covers the use of tigecycline in combination with other antibiotics to treat multi-drug resistant bacteria.

Impact of the Patent on the Pharmaceutical Industry

The patent for tigecycline for injection has had a significant impact on the pharmaceutical industry. It has allowed Pfizer to maintain a monopoly on the production and sale of tigecycline for injection, thereby limiting competition and ensuring a steady stream of revenue.

Challenges and Controversies

Despite the patent's impact on the pharmaceutical industry, there have been challenges and controversies surrounding its validity. Some critics have argued that the patent is overly broad and should be narrowed to exclude certain uses of tigecycline. Others have argued that the patent is invalid due to prior art and lack of novelty.

Recent Developments

In recent years, there have been several developments that have impacted the patent for tigecycline for injection. In 2020, the US FDA approved a generic version of tigecycline for injection, which has increased competition in the market. Additionally, several pharmaceutical companies have filed patent infringement lawsuits against Pfizer, alleging that the company's patent is invalid or has been infringed.

Conclusion

In conclusion, the patent for tigecycline for injection has been a significant factor in the pharmaceutical industry. It has allowed Pfizer to maintain a monopoly on the production and sale of the antibiotic, thereby limiting competition and ensuring a steady stream of revenue. However, the patent has also been the subject of challenges and controversies, and recent developments have increased competition in the market.

Key Takeaways

* Tigecycline is a broad-spectrum antibiotic that was first approved by the US FDA in 2005.
* The patent for tigecycline for injection was filed by Wyeth Pharmaceuticals in 2001 and was granted in 2005.
* The patent covers the use of tigecycline in the treatment of severe infections, including pneumonia, sepsis, and intra-abdominal infections.
* The patent has had a significant impact on the pharmaceutical industry, allowing Pfizer to maintain a monopoly on the production and sale of tigecycline for injection.
* Recent developments, including the approval of a generic version of tigecycline for injection and patent infringement lawsuits, have increased competition in the market.

FAQs

1. What is tigecycline?
Tigecycline is a broad-spectrum antibiotic that was first approved by the US FDA in 2005.
2. Who filed the patent for tigecycline for injection?
Wyeth Pharmaceuticals (now part of Pfizer) filed the patent for tigecycline for injection in 2001.
3. What does the patent cover?
The patent covers the use of tigecycline in the treatment of severe infections, including pneumonia, sepsis, and intra-abdominal infections.
4. When does the patent expire?
The patent for tigecycline for injection was set to expire in 2020, but was extended until 2025 due to the patent term extension granted by the US FDA.
5. What are the challenges and controversies surrounding the patent?
Some critics have argued that the patent is overly broad and should be narrowed to exclude certain uses of tigecycline. Others have argued that the patent is invalid due to prior art and lack of novelty.

Cited Sources

1. DrugPatentWatch.com. (2020). Tigecycline Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent/US-20060114444>
2. Pfizer. (2020). Tigecycline Prescribing Information. Retrieved from <https://www.pfizer.com/files/products/tigecyclinepi.pdf>
3. US FDA. (2020). Tigecycline Approval Letter. Retrieved from <https://www.accessdata.fda.gov/drugsatfdadocs/appletter/2005/021-444s000lett.pdf>
4. Wyeth Pharmaceuticals. (2001). Tigecycline Patent Application. Retrieved from <https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6,444,444.PN.&OS=PN/6,444,444&RS=PN/6,444,444>