JW Pharmaceutical’s hyperlipidemia combination product, Livalozet which combines pitavastatin and ezetimibe and accounts for 10% of its total sales is expected to face fierce competition from generic drugs this year. This challenge comes as sales of existing generics are already increasing, and several small pharmaceutical companies are preparing to enter the market in August, targeting the impending patent expiry.
According to industry sources on the 18th, Hana Pharmaceutical recently received approval from the Ministry of Food and Drug Safety for bioequivalence tests for both “Lipatori Tablets 4/10 mg” and “Livalozet Tablets 4/10 mg.” To obtain approval for a generic product, manufacturers must provide data demonstrating equivalence in efficacy, safety, and quality compared to the original drug; these tests are a key part of that process.
Livalozet is a hyperlipidemia combination product that pairs pitavastatin, which suppresses cholesterol synthesis in the liver (a component originally acquired by JW Pharmaceutical from Japan’s Kowa and Nissan Chemical in 2005 and also an ingredient of the hyperlipidemia drug Rivaro), with ezetimibe, which inhibits cholesterol absorption. Since its launch in 2021, Livalozet has rapidly secured a strong position in the hyperlipidemia market. Last year, it recorded sales of KRW 76.2 billion (USD 57 million)—accounting for over 10% of JW Pharmaceutical’s consolidated sales of KRW 714.9 billion (USD 535 million).
However, Livalozet has faced generic challenges even before its patent expired. Five pharmaceutical companies—Daewon Pharmaceutical, Celltrion Pharm, Anguk Pharm, Dongkwang Pharmaceutical, and Boryung—won patent invalidation trials against Kowa, the original developer. As a result, these companies have been selling their generic versions since November 2023.
While Livalozet's sales continue to grow, the growth rate appears to be slowing. Sales surged from KRW 31.8 billion (USD 23.7 million) in 2022 to KRW 70.4 billion (USD 52.4 million) in 2023, with last year’s figures reaching KRW 76.2 billion (USD 57 million)—an 18.4% increase over the previous year. At the end of 2023, Daewon Pharmaceutical’s "Tabarozet" and Anguk Pharm’s "Pevarozet" each recorded sales exceeding KRW 10 billion (USD 7.5 million), gradually increasing their market shares.
In particular, with the scheduled expiry of Livalozet’s use patent in August, generic competition is expected to accelerate. Not only did Hana Pharmaceutical receive approval for bioequivalence tests, but last month Ilyang BioPharma also obtained approval for "Pitarozet Tablets" and Livalozet Tablets, while Korea Huetex Pharmaceutical secured similar approval in December last year. Every month, at least one company is signaling its entry into the Livalozet market.
Nevertheless, JW Pharmaceutical anticipates that even as generic competition increases, the overall impact on sales will be limited, as both Livalozet and its generic counterparts are collectively expanding the market.
A JW Pharmaceutical representative stated, “The pitavastatin component is highly popular due to its lower incidence of side effects, such as muscle and liver function abnormalities, compared to other statin products. Rather than purely competing with generic manufacturers, we expect that the market will grow collaboratively, leading to mutual success.”
In addition, JW Pharmaceutical plans to differentiate its offerings by launching a triple-combination product that contains pitavastatin, valsartan, and amlodipine. This product, designed to treat both hyperlipidemia and hypertension, is targeted for release later this year.
