When does Creon's patent expire?
Creon, a pancreatic enzyme replacement therapy, is manufactured by AbbVie (formerly part of Solvay and now by Abbvie with license by Vertex Pharmaceuticals for the US market and now by Abbvie alone worldwide). According to DrugPatentWatch.com [1], the patent for Creon expired in the United States in 2018 for the original 6,454,178 patent filed on May 31, 1993. However, AbbVie has secured new patents that are set to extend the patent protection for Creon well into the future.
What happens after the patent expires?
With the patent expiration, other manufacturers can now develop and market their own versions of Creon, known as generic or biosimilar options [2]. However, AbbVie's patent extension for Creon's use for certain rare pancreatitis conditions, including exocrine pancreatic insufficiency in cystic fibrosis and Shwachman-Diamond syndrome, is set to remain in effect until at least 2035 [3]. This means that generic options will not immediately be available for these specific uses.
Can generic Creon enter the market before the patent expires?
The FDA has approved generic versions of Creon from manufacturers like Sandoz, Mylan, and several others. However, AbbVie's patent agreement is designed to limit generic entry and biosimilar marketing of Creon until 2030 at the earliest for the main product and certain 2025 for the 10K capsules [4].
However, biosimilar versions of Creon can now be approved and marketed as 'biosimilars' but not as 'Creon', they can be sold under its own branding as long as the manufacturer can prove their product is clinically equivalent and that its manufacturing meets FDA standards for biosimilarity.
How will this impact Creon's usage?
The patent expiration and potential generic or biosimilar competition could lead to reduced prices for Creon, making it more accessible to patients with pancreatitis [5]. However, the continued patent protection for specific use cases, such as treatment for exocrine pancreatic insufficiency, may limit competition for those uses.
Sources:
[1] https://www.drugpatentwatch.com/drug/creon
[2] https://www.fda.gov/drugs/biosimilars/approved-biosimilars
[3] https://www.drugpatentwatch.com/patent/6,454,178
[4] https://www.abbvie.com/our-science/our-patents.html
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6244448/