See the DrugPatentWatch profile for vascepa
Vascepa, a medication used to lower triglyceride levels, has not seen a significant uptake in generic versions despite its patents expiring. This can be attributed to several factors.
Firstly, the active ingredient in Vascepa, icosapent ethyl, is a complex compound to manufacture. It is derived from fish oil, and the process to extract and purify it is intricate and costly [1]. This complexity may deter potential generic manufacturers due to the high barriers to entry.
Secondly, the market for Vascepa and its generics is not as large as one might expect. Although high triglyceride levels are a common issue, many patients are managed with lifestyle changes and other medications before being prescribed Vascepa or its generics [2]. This limits the potential market size for these drugs.
Thirdly, the patent landscape for Vascepa is more complex than a simple expiration date. While the main patents for Vascepa expired in 2020, Amarin, the company that manufactures Vascepa, has filed multiple patents related to the drug's use, formulation, and manufacturing process [3]. These additional patents can create a significant barrier for generic manufacturers, as they may need to challenge these patents in court before they can launch their generic versions [4].
In conclusion, the reasons for the slow uptake of Vascepa generics are multifaceted, involving the complexity of manufacturing icosapent ethyl, the size of the market, and the complex patent landscape.
Sources:
[1] DrugPatentWatch.com. (2021). Icosapent Ethyl (Vascepa) Patent Expiration & Generics. Retrieved from
https://www.drugpatentwatch.com/icosapent-ethyl-vascepa-patent-expiration-generics/
[2] Mayo Clinic. (2020). High triglycerides. Retrieved from
https://www.mayoclinic.org/diseases-conditions/high-blood-cholesterol/in-depth/triglycerides/art-20048186
[3] Amarin Corporation. (2021). Intellectual Property. Retrieved from
https://investor.amarincorp.com/ip
[4] Harvard Health Publishing. (2019). Generic drugs: Are they as good as brand-name drugs? Retrieved from
https://www.health.harvard.edu/staying-healthy/generic-drugs-are-they-as-good-as-brand-name-drugs