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How does tigecycline s patent extension influence availability of cheaper antibiotics?

See the DrugPatentWatch profile for tigecycline

Tigecycline is an antibiotic used to treat various bacterial infections, including complicated skin and intra-abdominal infections, community-acquired pneumonia, and diabetic foot infections [1]. The patent for tigecycline, which was originally held by Wyeth (now Pfizer), expired in 2015 [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, until December 2015 [2].

The patent extension for tigecycline has had an impact on the availability of cheaper antibiotics. During the period of patent exclusivity, generic versions of tigecycline were not allowed to be sold in the United States [2]. This meant that patients and healthcare providers had limited options for accessing tigecycline at a lower cost [5].

However, since the patent expiration and the end of the patent extension, generic versions of tigecycline have become available [2]. This has led to increased competition in the market and has resulted in lower prices for tigecycline [5].

In conclusion, the patent extension for tigecycline has had an impact on the availability of cheaper antibiotics. During the period of patent exclusivity, generic versions of tigecycline were not available, leading to limited options for accessing the drug at a lower cost. However, since the patent expiration and the end of the patent extension, generic versions of tigecycline have become available, resulting in increased competition and lower prices.

Sources:

1. FDA. Tigecycline. <https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/tigecycline>.
2. DrugPatentWatch. Tigecycline (Tygacil) Patent Expiration & Generics. <https://www.drugpatentwatch.com/patent/tigecycline-tygacil-pfizer-inc/>.
3. FDA. Patent Term Extension. <https://www.fda.gov/industry/developing-products-human-use/at-fda/patent-term-extension>.
4. USPTO. Patent Term Extension. <https://www.uspto.gov/patents/law/examination/patent-term-extension>.
5. IMS Health. Generic Competition and Drug Prices. <https://www.imshealth.com/en/thought-leadership/insights-and-resources/ih-services/generic-competition-and-drug-prices>.


Other Questions About Tigecycline :  What factors influence tigecycline resistance development? Does tigecycline use increase the risk of liver damage? What is the effect of tigecycline on ast enzyme activity?





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