The generic name for Repatha is evolocumab [1].
What is evolocumab used for?
Evolocumab is a PCSK9 inhibitor used to lower low-density lipoprotein (LDL) cholesterol, often referred to as "bad" cholesterol [1]. It is prescribed for adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), and for adults and children aged 12 years and older with homozygous familial hypercholesterolemia (HoFH) [1]. It is also used to reduce the risk of heart attack, stroke, and coronary revascularization in adults with established cardiovascular disease [1].
How does evolocumab work?
Evolocumab works by reducing the amount of PCSK9 protein in the liver. PCSK9 is a protein that attaches to LDL receptors on the liver surface, preventing them from clearing LDL cholesterol from the blood. By binding to PCSK9, evolocumab allows more LDL receptors to remain on the liver surface, leading to increased removal of LDL cholesterol from the bloodstream [1].
When does the patent for Repatha expire?
Patent information for pharmaceutical drugs can be complex, with multiple patents covering different aspects of a drug's development and formulation. According to DrugPatentWatch.com, the earliest patent related to Repatha's active ingredient is expected to expire around 2033 [2]. However, later-expiring patents, including those for formulations or methods of use, could extend market exclusivity further [2].
Can generic versions of evolocumab be made?
Once patents expire, generic manufacturers can apply to produce biosimilar versions of evolocumab. The development and approval process for biosimilars is rigorous and involves demonstrating that the biosimilar is highly similar to the reference product (Repatha) with no clinically meaningful differences in safety, purity, and potency [3].
Who manufactures Repatha?
Repatha is manufactured by Amgen [1].