Atorvastatin/ezetimibe prescriptions top ₩200 billion in 1H

Prescriptions for atorvastatin/ezetimibe combinations quadruple over 5 years as generics flood the market

Rapid market expansion following the entry of more than 100 domestic generic products in 2021

Chong Kun Dang expands market presence…secures gains despite returning Atozet marketing rights

The prescription market for atorvastatin/ezetimibe combination products continues to post strong growth. Driven by rising demand for combination therapies for hyperlipidemia and the indiscriminate influx of generics, the market has grown more than threefold compared with five years ago, with quarterly prescription value surpassing KRW 100 billion. Generic products manufactured by Chong Kun Dang, which entered the market 1 month ahead of competitors, captured a 24% market share, posing a serious challenge to Atozet. Industry observers say Chong Kun Dang has expanded its market influence and secured tangible commercial gains through its early entry into the generic market and its contract manufacturing strategy.

Atorvastatin/ezetimibe prescriptions exceed KRW 200 billion in H1… generics drive fourfold market growth in 5 years

According to market research institution UBIST on the 11th, outpatient prescriptions for atorvastatin/ezetimibe combination products totaled KRW 207.3 billion in the first half of the year, up 14.0% from the same period last year. Prescriptions reached KRW 101.5 billion in Q1, up 13.9% year over year, and KRW 105.8 billion in A2, representing another 14.0% increase.

Outpatient prescriptions of atorvastatin/ezetimibe combinations in Korea (Unit: KRW 100 million, Source: UBIST, AI-generated image)

The prescription market for atorvastatin/ezetimibe combinations has expanded rapidly, growing from KRW 50.2 billion in the 1H 2021 to more than four times that level in just five years. Quarterly, prescriptions rose from KRW 20.1 billion in Q1 2021 to over KRW 100 billion, representing more than fivefold growth over the same period.

Demand for atorvastatin/ezetimibe combinations has increased sharply as statin/ezetimibe combinations have demonstrated excellent efficacy in lowering low-density lipoprotein cholesterol (LDL-C), driving rapid expansion of the market.

Organon Korea’s Atozet is the original atorvastatin/ezetimibe combination product. Beginning in 2021, more than 100 domestic pharmaceutical companies entered the atorvastatin/ezetimibe market almost simultaneously with generic products, accelerating market growth.

In October 2020, Chong Kun Dang obtained approval for Lipilouzet, a combination product containing the same ingredients as Atozet, after demonstrating equivalence in a clinical trial. At the same time, 22 companies received approval for authorized generics based on Lipilouzet, and those products were added to the National Health Insurance reimbursement list in April 2021.

Beginning in February 2021, 88 additional companies received approval for Atozet generics, which were listed for reimbursement in May, one month later than the Lipilouzet authorized generics. Two more companies obtained approval in June 2021, bringing the total number of domestic companies participating in the Atozet market to 113.

Both Atozet and generic products posted strong growth.

In Q2, Atozet generated KRW 33.9 billion in prescriptions, up 7.2% from the same period last year. Compared with KRW 22.3 billion in Q2 2021, prescriptions increased 51.9% over five years. During Q2, generic products generated combined prescriptions of KRW 71.9 billion, accounting for 67.9% of the atorvastatin/ezetimibe combination market.

Among the leading generics, Jeil Pharmaceuticals’ Lipitor Plus stood out with KRW 13.2 billion in Q2 prescriptions, up 13.9% year over year. Viatris, which markets the atorvastatin monotherapy Lipitor, joined the marketing effort for Lipitor Plus, creating commercial synergies in the market.

Yuhan Corp's Atovamibe and Daewoong Pharmaceutical's Litorvazet ranked among the leading generics with Q2 prescriptions of KRW 6.9 billion and KRW 5.7 billion, respectively. Atovamibe is manufactured by Yuhan, while Litorvazet is produced under contract by Jinyang Pharm.

Chong Kun Dang-manufactured products record KRW 24.9 billion in Q2 prescriptions, capturing a 23.5% market share…company’s return of Atozet rights proves commercially advantageous.

When Atozet generics are grouped by contract manufacturer, products manufactured by Chong Kun Dang account for the largest market share.

Among the 113 companies that entered the atorvastatin/ezetimibe combination market, only 11 manufacture products themselves: Dasan Pharmaceutical, DongKoo Bio & Pharma, Aprogen Pharmaceuticals, Withus Pharmaceutical, Yuhan Corp, Ildong Pharmaceutical, Genuone Sciences, Jeil Pharmaceutical, Chong Kun Dang, GL Pharma, and Jinyang Pharm. The remaining 102 companies entered the market through contract manufacturing.

Jinyang Pharm and Chong Kun Dang each manufacture Atozet generics for more than 20 client companies.

Jinyang Pharm manufactures products for Ahn-Gook New Pharm, Daewon Pharmaceutical, Ari Pharmaceutical, Samick Pharm, CMG Pharmaceutical, Kolon Pharma, Daewoong Bio, iCure, PMG Pharm, Daehwa Pharmaceuticals, KyungDong Pharm, Dongwha Pharmaceutical, Dongkwang Pharmaceutical, Huons, Alison Pharmac, BCWorld Healthcare, Whan In Pharm, Korea Biochem Pharm, HanAll Biopharma, Humedix, and Huons Meditech.

Chong Kun Dang manufactures atorvastatin/ezetimibe combination products for Pharmgen Science, Ahn-Gook Pharmaceutical, Il-Yang Pharm, Celltrion Pharm, Arlico Pharmaceutical, Hana Pharm, Alvogen Korea, Sam Chun Dang Pharm, Dongkook Pharmaceutical, Korea Prime Pharm, Kyongbo Pharmaceutical, Hwail Pharm, Kukje Pharm, Korea United Pharm, Boryung, Yungjin Pharmaceutical, Yuyu Pharma, HK inno.N, and SK Chemicals. DongKoo Bio & Pharma and Dasan Pharmaceutical manufacture generics for 12 and six client companies, respectively.

Ai-generated image

Products manufactured by Chong Kun Dang generated a combined KRW 24.9 billion in prescriptions in Q2. That represents nearly a fivefold increase from KRW 5.1 billion in 2021, reflecting continued strong growth. Chong Kun Dang-manufactured products accounted for 23.5% of the atorvastatin/ezetimibe combination market in Q2, narrowing the gap with the original product Atozet, which held a 32.1% share, to just 8.6 percentage points.

Among Atozet generics alone, Chong Kun Dang-manufactured products accounted for 34.6% of prescriptions, meaning that more than one-third of prescriptions for domestic Atozet generics were supplied by Chong Kun Dang.

Chong Kun Dang had co-promoted Atozet with Organon since 2016, but Boryung became the new marketing partner this month. From Chong Kun Dang's perspective, focusing on manufacturing and marketing generics may have been more commercially advantageous, given that its generic portfolio has achieved a market share approaching that of the original product. In general, self-manufactured products carry substantially lower production costs than innovative drugs introduced and marketed on behalf of multinational pharmaceutical companies.

Chong Kun Dang's own atorvastatin/ezetimibe combination product, Lipilouzet, posted KRW 1.1 billion in Q2 prescriptions, up 38.9% year over year, maintaining a clear upward trend. Among products manufactured by Chong Kun Dang, HK inno.N's Zepitor and Boryung's L50 also stood out, recording KRW 3.4 billion and KRW 3.3 billion in Q2 prescriptions, respectively.

Generics manufactured by Jinyang Pharm generated KRW 16.5 billion in prescriptions during Q2, accounting for 15.6% of the atorvastatin/ezetimibe combination market. Among Jinyang-manufactured products, those marketed by Daewoong Pharmaceutical, KyungDong Pharm, Jinyang Pharm, and Dongwha Pharmaceutical each generated more than KRW 1 billion in quarterly prescriptions.

Yuhan’s Atovamibe and GC Biopharma’s's Azet Duo generated a combined KRW 7.7 billion in Q2 prescriptions, representing a 7.3% market share. Products manufactured by Withus Pharmaceutical, Dasan Pharmaceutical, and DongKoo Bio & Pharma each accounted for less than 2% of the Atozet generic market.