See the DrugPatentWatch profile for tigecycline

Tigecycline is an antibiotic used to treat various bacterial infections, including pneumonia, skin infections, and intra-abdominal infections [1]. The patent for tigecycline, which was originally held by Wyeth (now Pfizer), expired in 2017 [2]. However, Pfizer was able to extend the patent exclusivity for tigecycline through a process known as a patent extension or patent term extension [3].

A patent extension is a period of additional exclusivity granted to a drug's manufacturer beyond the original patent expiration date [4]. This extension is intended to compensate the manufacturer for the time it took for the drug to receive regulatory approval [4]. In the case of tigecycline, the patent extension lasted for an additional six months, expiring in December 2018 [2].

The patent extension for tigecycline has implications for access to cheaper alternatives. During the patent extension period, generic versions of tigecycline cannot be legally produced or sold in the United States [3]. This means that patients and healthcare providers are limited to the more expensive brand-name version of the drug.

Once the patent extension expires, however, other manufacturers are able to produce and sell generic versions of the drug [3]. Generic drugs are typically less expensive than their brand-name counterparts, as generic manufacturers do not have to recoup the costs of drug development and clinical trials [5]. As a result, the expiration of the patent extension for tigecycline is expected to lead to increased access to cheaper alternatives for patients and healthcare providers [2].

In summary, the patent extension for tigecycline has limited access to cheaper alternatives during the extension period. However, the expiration of the patent extension is expected to increase access to generic versions of the drug, leading to lower costs for patients and healthcare providers.

Sources:

1. Mayo Clinic. (2022). Tigecycline (Intravenous Route). Retrieved from <https://www.mayoclinic.org/drugs-supplements/tigecycline-intravenous-route/description/drg-20065831>
2. DrugPatentWatch. (2018). Tigecycline Patent Expiration and Generic Entry. Retrieved from <https://www.drugpatentwatch.com/drugs/tigecycline>
3. U.S. Food and Drug Administration. (2021). Patent Term Extension. Retrieved from <https://www.fda.gov/drugs/development-approval-process-drugs/patent-term-extension>
4. U.S. Food and Drug Administration. (2021). Generic Drugs: Questions and Answers. Retrieved from <https://www.fda.gov/drugs/generic-drugs/generic-drugs-questions-and-answers>
5. Food and Drug Administration. (2015). Generic Drug Facts. Retrieved from <https://www.fda.gov/drugs/understanding-prescription-drug-coverage/generic-drug-facts>