Yuhan Corporation has received regulatory approval for a triple combination diabetes therapy containing empagliflozin, linagliptin, and metformin, marking a significant expansion of its diabetes portfolio. The new therapy, “Tra Duo Empa XR,” could drive prescription synergy through Yuhan’s existing sales network for “Trajenta,” a linagliptin-based drug.

Approved on July 29 by the Ministry of Food and Drug Safety (MFDS), Tra Duo Empa XR is intended for patients with type 2 diabetes who do not achieve sufficient blood sugar control with dual therapy. The product simplifies treatment by combining three active ingredients into a single extended-release tablet.

Yuhan has marketed “Trajenta” since 2011 under a partnership with Boehringer Ingelheim Korea and also launched the dual therapy “Trajenta Duo” (linagliptin + metformin). Following the 2024 patent expiry of linagliptin, the Korean market saw the approval of over 230 generics and combinations. Yuhan responded by introducing “Tra Duo XR,” a linagliptin-metformin product.

Empagliflozin’s patent (marketed as “Jardiance”) is set to expire this October, and follow-on products are expected to gain approval soon.

“Tra Duo Empa XR” is Korea’s first approved product to combine an SGLT-2 inhibitor (empagliflozin), a DPP-4 inhibitor (linagliptin), and metformin. Industry analysts note Yuhan’s potential to capitalize on growing demand for multi-drug therapies, particularly in clinics where prescriptions often shift from monotherapy to more comprehensive regimens.

However, Yuhan’s move may create friction with Boehringer Ingelheim Korea, as it now markets a product with the same ingredients it once distributed under partnership. Prescription data show declining trends: Trajenta’s outpatient revenue fell from $46.1 million in 2022 to $36.0 million in 2024, while Trajenta Duo dropped from $49.0 million to $38.6 million during the same period.

As Yuhan accelerates its promotion of Tra Duo Empa XR, industry attention is focused on whether the longstanding partnership with Boehringer Ingelheim will continue amid growing competition in the triple and quadruple therapy segment.

When asked about the launch timeline, a Yuhan official declined to comment, stating, “There’s nothing to share at this time.”