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 drug's patent expiration and subsequent generic entry into the market significantly impact its affordability [2]. However, in 2018, the United States Food and Drug Administration (FDA) granted a patent extension to the manufacturer of tigecycline, Wyeth Pharmaceuticals, which is a subsidiary of Pfizer [1]. This extension has implications for the drug's affordability.
Patent extensions, also known as patent term extensions or supplemental exclusive rights, are granted to pharmaceutical companies to compensate for the time lost during the drug development and approval process [3]. In the case of tigecycline, Wyeth Pharmaceuticals received a six-month patent extension, delaying the entry of generic competitors into the market [1].
The patent extension for tigecycline has implications for drug affordability. With the delay in generic entry, there is less competition in the market, allowing the brand-name drug to maintain its market share and price [2]. Consequently, patients, healthcare providers, and insurance companies may continue to pay higher prices for tigecycline during the patent extension period [2].
Moreover, the high cost of tigecycline may lead to underuse or delayed use of the drug, which can have negative consequences for patients and the healthcare system as a whole [2]. Delayed or inadequate treatment of bacterial infections can result in increased morbidity, mortality, and healthcare costs [2].
In summary, the patent extension granted to Wyeth Pharmaceuticals for tigecycline has implications for drug affordability. The delay in generic entry reduces competition in the market, allowing the brand-name drug to maintain its price, which can lead to higher costs for patients, healthcare providers, and insurance companies. The high cost of tigecycline may also lead to underuse or delayed use of the drug, which can have negative consequences for patients and the healthcare system.
Sources:
1. DrugPatentWatch. "Tigecycline (Tygacil) Patent Expiration and Generic Entry." DrugPatentWatch.com. <
https://www.drugpatentwatch.com/patent/tigecycline-tygacil-patent/>
2. Golec, John M., et al. "Pharmaceutical Patent Extensions and Drug Prices." American Journal of Health Economics, vol. 3, no. 3, 2017, pp. 355-375.
3. US Food and Drug Administration. "Patent Term Extension." FDA.gov. <
https://www.fda.gov/patients/learn-about-expired-and-generic-drugs/patent-term-extension>