With flagship drugs losing exclusivity, the company accelerates new pipeline development to safeguard market position

Boehringer Ingelheim Korea is under increasing pressure as key products lose patent protection, ushering in waves of generic competition. Its diabetes treatments Trajenta and Jardiance, along with pulmonary fibrosis therapy Ofev, are either off-patent or nearing expiration.
Trajenta saw its first generic launch in June 2023 after the expiration of its compound patent. Although competition was initially limited due to first-filer exclusivity, that window closed on March 8. Since then, major South Korean players—including Hanmi Pharmaceutical and Genuone Sciences—have entered the market, putting additional strain on Trajenta’s share.
Jardiance, one of Korea’s best-selling SGLT-2 inhibitors with annual revenue exceeding $72 million, is expected to lose patent protection on October 23, 2025. While hundreds of generic approvals have already been granted across all dosage forms, several firms have also bypassed the crystal form patent, setting the stage for immediate competition upon expiration. The launch timeline for the combination product Esglito, however, may hinge on the outcome of ongoing litigation.
Meanwhile, Ofev—which has historically operated outside reimbursement—will be newly listed under Korea’s National Health Insurance system in May. Its compound patent expired in January, and generics by Daewoong Pharmaceutical (Ofevia), Yungjin Pharm (Nintebro), and Ildong Pharmaceutical (Cuinnta) have already secured regulatory approval. These competitors are expected to seek reimbursement and potentially launch within three months. Some firms have signaled aggressive pricing, further intensifying competition in the post-reimbursement landscape.
Trajenta and Jardiance have long driven Boehringer’s Korean revenues, while Ofev has performed strongly even without coverage. Now, with all three facing imminent or active generic pressure, the company is at a critical juncture.
In response, Boehringer Ingelheim is accelerating its pipeline strategy. In a recent interview, Ana-Maria Boie, CEO of Boehringer Ingelheim Korea, shared plans to launch at least 20 new drugs or indications globally—including in Korea—within the next seven years. Strategic focus areas include cardio-renal-metabolic (CRM) diseases, pulmonary fibrosis (PF), and oncology.
For CRM, the company is preparing next-generation assets following Jardiance, Trajenta, and Twynsta, including the dual GLP-1/glucagon agonist Survodutide, and ASi+EMPA, which combines an aldosterone synthase inhibitor with empagliflozin. In neurology, Metalyse—an acute ischemic stroke therapy—is under review in South Korea. In PF, Nerandomilast is being developed as a successor to Ofev, and in oncology, Boehringer is preparing to submit the non-small cell lung cancer therapy Zongertinib to Korea’s Ministry of Food and Drug Safety.
Industry stakeholders are watching closely to see whether Boehringer can offset losses from the patent cliff and regain momentum through its next wave of therapies.
