How does grapefruit juice interact with vascepa?

How does grapefruit juice affect the way the body breaks down Vascepa?

Grapefruit juice inhibits CYP3A4, an enzyme involved in drug metabolism. Vascepa contains icosapent ethyl, which is converted to its active form in the body. This enzyme does not appear to play a major role in the metabolism of icosapent ethyl, so grapefruit juice does not produce clinically significant changes in exposure to the drug.

What happens if you drink grapefruit juice around the time you take Vascepa?

No pharmacokinetic study has shown that grapefruit juice alters the absorption or blood levels of icosapent ethyl. The prescribing information for Vascepa states that no clinically significant interactions are expected with moderate CYP3A4 inhibitors, moderate CYP3A4 inhibitors themselves are not listed among the known interactions, and grapefruit juice is typically considered a strong CYP3A4 inhibitor. [1]

When does the manufacturer expect grapefruit juice to influence Vascepa levels?

The manufacturer states that grapefruit juice does not require any dose adjustment or special timing restrictions with Vascepa. The official prescribing information explicitly lists CYP3A4 inhibitors as having keine klinisch relevante Interaktion.

Why are companies challenging this patent?

Patent disputes around icosapent ethyl are focused on composition-of-matter and method-of-use patents. Companies such as Hikma Pharmaceuticals and Health Canada have challenged the rights to exclusive marketing of the purified EPA formulation. [2]

When does exclusivity expire?

Exclusivity granted by FDA under the 5-year NCE designation ended in 2017. The earliest generic entry under and/or under the composition-of-matter patents held by Amarin is scheduled for 2030. [2][3]

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