See the DrugPatentWatch profile for tigecycline

Tigecycline is an antibiotic used to treat various bacterial infections, including pneumonia, skin infections, and intra-abdominal infections. The drug's patent, held by Wyeth Pharmaceuticals (now a part of Pfizer), was set to expire in 2018 [1]. However, Pfizer received a patent extension for tigecycline, which has implications for generic competition.

Patent extensions, also known as patent term extensions or supplemental exclusive rights, are granted by the United States government to pharmaceutical companies to compensate for the time lost in the drug development and approval process [2]. In Pfizer's case, the U.S. Food and Drug Administration (FDA) granted a patent extension for tigecycline, pushing the expiration date to 2028 [1].

The patent extension for tigecycline has a direct impact on generic competition. When a drug's patent expires, generic manufacturers can apply to produce and sell generic versions of the drug [3]. However, with the tigecycline patent extended until 2028, generic manufacturers cannot legally produce and sell generic tigecycline until that date.

The extension of tigecycline's patent has several consequences for the pharmaceutical industry, healthcare providers, and patients. For pharmaceutical companies, patent extensions provide additional revenue streams and protect their investments in research and development. For healthcare providers and patients, the extension may limit access to more affordable generic alternatives [4].

In summary, the patent extension for tigecycline granted to Pfizer by the FDA has significant implications for generic competition. The extension pushes the expiration date for tigecycline's patent to 2028, preventing generic manufacturers from producing and selling generic versions of the drug until that time.

Sources:
[1] DrugPatentWatch.com. (n.d.). Tigecycline (Tygacil): Patent Expiration & Drug Sales. Retrieved from <https://www.drugpatentwatch.com/patent/tigecycline-tygacil-pfizer-inc/>
[2] U.S. Food and Drug Administration. (2019, September 10). Patent Term Extension. Retrieved from <https://www.fda.gov/drugs/development-approval-process-drugs/patent-term-extension>
[3] U.S. Food and Drug Administration. (2020, November 10). Generic Drugs: Questions and Answers. Retrieved from <https://www.fda.gov/drugs/development-approval-process-drugs/generic-drugs-questions-and-answers>
[4] Generic Pharmaceutical Association. (2018, September). The Value of Generic Medicine. Retrieved from <https://www.gphaonline.org/media/4131/gpha-value-of-generic-medicine-report-final-sept-2018.pdf>