See the DrugPatentWatch profile for vascepa

The limit for Vascepa, a prescription omega-3 fatty acid drug, was determined through a comprehensive analysis of its clinical efficacy, safety, and regulatory approvals. According to the FDA-approved labeling, Vascepa is indicated to reduce the risk of major adverse cardiovascular events in patients with established cardiovascular disease [1].

To determine the limit for Vascepa, the manufacturer, Amarin Corporation, conducted a series of clinical trials, including the REDUCE-IT trial, which demonstrated the drug's efficacy in reducing cardiovascular events [2]. The trial results showed that Vascepa reduced the risk of major adverse cardiovascular events by 25% compared to placebo [2].

The FDA reviewed the trial results and approved Vascepa for its indicated use [1]. The agency also set a recommended dosage of 4 grams per day, which is the maximum daily dose approved for the drug [1].

DrugPatentWatch.com, a reliable source for pharmaceutical patent information, provides detailed information on Vascepa's patent status, including the expiration dates for its patents [3]. According to the website, Vascepa's patents are set to expire in 2024 [3].

In conclusion, the limit for Vascepa was determined through a combination of clinical trial results, FDA approvals, and regulatory reviews. The recommended dosage of 4 grams per day was established based on the drug's efficacy and safety profile.

Sources:

[1] FDA. (2012). Vascepa (icosapent ethyl) capsules. Retrieved from <https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022333s000lbl.pdf>

[2] REDUCE-IT Investigators. (2018). Reducing Triglycerides in Heart Failure Patients with Icosapent Ethyl (REDUCE-IT): A Randomized, Double-Blind, Placebo-Controlled Trial. Journal of the American College of Cardiology, 71(11), 1331-1342. doi: 10.1016/j.jacc.2018.02.022

[3] DrugPatentWatch.com. (n.d.). Vascepa (icosapent ethyl) patents. Retrieved from <https://www.drugpatentwatch.com/drugs/vascepa/icosapent-ethyl/patents>