Lilly’s 'Cymbalta' is withdrawing from the KOR mkt after 20 years

Eli Lilly Korea voluntarily withdrew the product approval for Cymbalta

Co-promotion agreement with Boryung has been terminated…Lilly is restructuring its global portfolio amid recurring supply shortages

39 generic products in South Korea maintain their marketing authorization…the market influence is expected to be minimal as alternative therapeutics can be prescribed

Product photo of Cymbalta

Eli Lilly Korea's central nervous system (CNS) therapy, 'Cymbalta Capsules' (duloxetine hydrochloride), is officially withdrawing from the South Korean market, nearly 20 years after its domestic launch.

According to the Ministry of Food and Drug Safety (MFDS), Eli Lilly Korea voluntarily withdrew the product approval for Cymbalta Capsules as of July 21. This license revocation appears to be a voluntary step in line with Lilly's transition in its global business strategy.

​Cymbalta is the leading therapeutic in the serotonin-norepinephrine reuptake inhibitor (SNRI) class. It acts by inhibiting the reuptake of serotonin and norepinephrine, key neurotransmitters in the brain, to restore chemical balance.

​Although widely known as a treatment for major depressive disorder (MDD) and generalized anxiety disorder (GAD), ​Cymbalta also demonstrates exceptional efficacy in modulating physical pain signals, leading to its widespread prescription across various conditions, including diabetic peripheral neuropathic pain, fibromyalgia, and osteoarthritis pain.

​Industry analysis suggests that this withdrawal was an expected outcome. In early 2024, Eli Lilly Korea terminated its long-standing co-promotion (joint sales) agreement with Boryung for Cymbalta.

​Following the termination of joint sales, operational and distribution gaps, alongside recurring supply shortages of Cymbalta in the domestic market over recent years, resulting in inconvenience for healthcare professionals and patients.

​Portfolio adjustments at the global level also appear to have contributed. Eli Lilly Korea had previously phased out CNS drug lineups, including the ADHD medication 'Strattera' and the antidepressant 'Prozac'. Additionally, the company previously executed market withdrawals of Cymbalta in certain overseas markets, such as Australia, citing declining profitability and intensifying generic competition.

​While the original drug is exiting the South Korean market, patient care is not expected to be significantly disrupted. This is because the substance patent for Cymbalta expired in 2014, allowing numerous domestic generics to establish a firm presence in the market.

​Currently, 39 generic products (active ingredient: duloxetine) hold regulatory approval in South Korea, including those from Myung In Pharm, Whan In Pharm, Hanlim Pharm, and Daewoong Pharmaceutical. With abundant market supply of therapeutic alternatives with identical active ingredients and dosages, patients currently taking Cymbalta are expected to transition smoothly to generic formulations through consultations with their healthcare providers.