First matching-form Ofev generic listed at half price

Ildong Pharmaceutical expands lineup from tablets to soft capsules

Insurance price ceiling of Ildong’s capsule form, equivalent in dosage form to the original, costs 60% less

A generic version of the chronic fibrotic interstitial lung disease treatment Ofev Soft Cap (nintedanib esylate) with the same formulation will be listed for reimbursement for the first time.

With its reimbursement entry at a price more than 50% lower than the original, full-scale market competition is expected.

According to industry sources on the 20th, Ildong Pharmaceutical’s Cuninta Soft Cap 100 mg and 150 mg will be added to the March reimbursement list.

The substance patent for Boehringer Ingelheim Korea's Ofev Soft Capsules expired in January last year. Subsequently, generic companies have successively launched their versions.

However, unlike the original drug, those products obtained approval in tablet formulations. From July last year, Yungjin Pharm, Ildong Pharmaceutical, Daewoong Pharmaceutical, Kolon Pharmaceutical, and others entered reimbursement. Whan In Pahrm also received approval for Ofenib Tab, but the drug is yet to be listed for reimbursement.

Until now, no reimbursed generic matching Ofev’s soft capsule formulation has been available. Ildong Pharmaceutical is expected to be the first to list a soft capsule generic, Cuninta Soft Cap, following its release of Cuninta Tab.

Cuninta Tab 150 mg was previously listed at KRW 13,500, roughly half the price of Ofev Soft Cap, which was priced at KRW 26,220.

Although generics designated as orphan drugs could receive equivalent pricing to the original, manufacturers pursued lower prices to strengthen market competitiveness.

The reimbursement ceiling prices for Cuninta Soft Cap 100 mg and 150 mg are set at KRW 8,500 and KRW 13,500, respectively. Notably, the lower dose represents about 40% of the originator’s 100 mg price of KRW 20,960.

Where earlier competition strategies relied on tablet differentiation and lower pricing, manufacturers can now seek prescription expansion based on identical formulation at half the cost.

Because switching prescriptions within the same formulation is expected to face less patient resistance, Ildong Pharmaceutical is anticipated to intensify its competitive positioning against Ofev.

Given that Ofev entered reimbursement relatively late, 8 years after domestic approval,  Ofev is expected to face intensifying competition from the later entrant generics.