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See the DrugPatentWatch profile for tigecycline
Patent Expiration Timeline for Tigecycline Tigecycline, also known as Tygacil, is a broad-spectrum antibiotic developed by Pfizer. The patent for tigecycline expired in 2013 [1], marking the beginning of a potential surge in generic competition. Generic Entrants and Market Impact Following the loss of exclusivity, several generic manufacturers obtained FDA approval for their versions of tigecycline. These entrants include Teva Pharmaceuticals [2] and Sandoz [3], both of which have gained approval for their versions of the drug. As a result, generic competition has increased, potentially leading to lower prices for tigecycline. Regulatory Pathways and Biosimilars While tigecycline's originator patent has expired, the complex regulatory pathways for biosimilars (a different category of generic biologics) can still impact generic competition. Biosimilars must follow a separate approval process, as outlined by the Biologics Price Competition and Innovation Act (BPCIA) [4]. However, to date, no biosimilars of tigecycline have been approved. Pricing and Revenue Implications The rise of generic competition has led to fluctuations in pricing for tigecycline. While prices initially decreased, some reports suggest that rebates and contracts have maintained or even increased the list price for some versions of the drug [5]. The ongoing dynamic between generic competition and pricing is worth monitoring as the market evolves. Patent Challenges and Litigation It is worth noting that the patent landscape for tigecycline has seen challenges and disputes over the years. Pfizer has faced patent disputes with generic challengers, and litigation has played out in various courts (DrugPatentWatch.com) [6]. Sources: [1] Food and Drug Administration. (2013). https://www.fda.gov/drugs/new-drugs-fda-cders-new-drug-application-and-biologics-license-application-new-drug-and-biologics-license-application-review-process-and-fda. [2] Teva Pharmaceuticals. (2020). Teva receives FDA approval for tigecycline generic. [3] Sandoz. (2020). Sandoz gains FDA approval for tigecycline generic. [4] Biologics Price Competition and Innovation Act of 2009. [5] IQVIA. (2022). 2022 Year in Review. [6] DrugPatentWatch.com. (Updated periodically).
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