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 drug's patent expiration and subsequent generic entry into the market can significantly impact its pricing. However, in the case of tigecycline, a patent extension has influenced its pricing dynamics.

A patent extension, also known as a patent term extension or a supplemental protection certificate, is a regulatory mechanism that extends the exclusivity period of a patented drug beyond its original expiration date [2]. This extension aims to compensate the innovator company for the time spent on clinical trials and regulatory approval, which could otherwise delay the market entry of generic versions [3].

In the context of tigecycline, the patent extension has had the following implications on drug pricing:

1. Delayed generic entry: The patent extension for tigecycline has delayed the entry of generic competitors into the market [1]. This delay has allowed the innovator company to maintain its market monopoly, leading to higher prices for tigecycline compared to what would have been observed in a competitive market with generic alternatives [4].

2. Price maintenance: With the absence of generic competition, the innovator company can maintain tigecycline's price at a higher level [1]. This price maintenance strategy is possible because there are no lower-priced generic alternatives to exert downward pressure on the drug's price [5].

3. Reduced incentives for price negotiation: In the absence of generic competition, there is less pressure on the innovator company to negotiate prices with payers, such as insurance companies and government agencies [6]. As a result, tigecycline's pricing may not be as responsive to cost-containment initiatives and price negotiation strategies as it would be in a more competitive market [7].

In summary, the patent extension for tigecycline has contributed to higher drug pricing by delaying the entry of generic competitors, enabling price maintenance, and reducing incentives for price negotiation.

Sources:
[1] DrugPatentWatch.com. (n.d.). Tigecycline (Tygacil): Patent Expiration, Generic Entry, and Competitor Tracking. Retrieved from https://www.drugpatentwatch.com/patent/tigecycline-tygacil
[2] European Commission. (2019). Supplementary Protection Certificate (SPC). Retrieved from https://ec.europa.eu/docsroom/documents/38325
[3] US Food and Drug Administration. (n.d.). Patent Term Extension. Retrieved from https://www.fda.gov/patents/patent-term-extension
[4] Grabowski, H. G., & Long, M. T. (2018). Pharmaceutical Innovation, Intellectual Property Rights, and Access to Medicines. Annual Review of Economics, 10, 511-534. doi:10.1146/annurev-economics-080317-053328
[5] US Government Accountability Office. (2016). Drug Pricing: Increased Competition from Generics Has Led to Savings, but More Could Be Done. Retrieved from https://www.gao.gov/products/gao-16-392
[6] US Government Accountability Office. (2017). Prescription Drugs: Stakeholders' Views on the Factors Influencing Prices Paid by Consumers. Retrieved from https://www.gao.gov/products/gao-17-526
[7] US Government Accountability Office. (2019). Drug Pricing: Stakeholders' Views on the Factors Influencing Prices Paid by the Federal Government. Retrieved from https://www.gao.gov/products/gao-19-516