Kwangdong secures first generic exclusivity for Tagrisso

Competes with CKD for market leadership

Approval of NSCLC treatment ‘Ktinib Tab’… secured 9-month first generic exclusivity upon substance patent expiry in December 2033

Domestic pharmaceutical companies are intensifying their push into the KRW 110 billion non-small cell lung cancer (NSCLC) treatment market centered on Tagrisso (osimertinib). Following Chong Kun Dang’s first generic approval in January, Kwangdong Pharmaceutical has also joined the ranks of companies obtaining first generic exclusivity, marking the start of a full-scale race to capture the market.

Kwangdong Pharmaceutical’s ‘Ktinib Tab’ Approved… Second after Chong Kun Dang

According to the Ministry of Food and Drug Safety, Kwangdong Pharmaceutical obtained first generic exclusivity on April 30 for its osimertinib mesylate product ‘Ktinib Tab (40mg, 80mg).’ This is the second such approval following Chong Kun Dang’s ‘Otinib Tab,’ which received approval on January 27.

The drug’s indications include, as a monotherapy: ▲Adjuvant treatment following complete resection in patients with NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations ▲Treatment of patients with unresectable locally advanced (Stage III) NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations whose disease has not progressed during or after platinum-based chemoradiotherapy ▲First-line treatment of patients with locally advanced or metastatic NSCLC harboring an EGFR exon 19 deletion or exon 21 (L858R) substitution mutation ▲Treatment of patients with EGFR T790M-positive locally advanced or metastatic NSCLC who have previously been treated with an EGFR-TKI.

Additionally, as a combination therapy, it is indicated for the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitutions, in combination with pemetrexed and platinum-based chemotherapy. These indications are identical to the original Tagrisso.

Like Chong Kun Dang, Kwangdong succeeded in circumventing Tagrisso’s formulation patent (set to expire January 2035), thereby securing first generic exclusivity. As a result, both companies will hold a roughly 9-month market exclusivity period starting from the expiry of the substance patent.

First, generic exclusivity is granted when a company successfully challenges a patent and meets the criteria of being among the first to file for approval. Both companies achieved patent circumvention in September last year by winning a passive scope confirmation trial regarding the formulation patent. AstraZeneca has since appealed, and a lawsuit to cancel the ruling is currently ongoing at the Intellectual Property High Court.

The approval applications were also submitted simultaneously to the MFDS, meaning both companies met the requirements for exclusivity.

The exclusivity period for Ktinib (during which sales of identical drugs are restricted) is set from December 28, 2033, to September 27, 2034.

Since the original drug Tagrisso’s substance patent remains valid until 2033, immediate market entry is not possible. However, both companies plan to enter the market immediately upon patent expiry, block latecomers, and capture the KRW 110 billion market.

Tagrisso vs. Leclaza… generics join the competition

Currently, the domestic NSCLC treatment market is dominated by AstraZeneca’s original drug Tagrisso and Yuhan’s domestic new drug Leclaza, which are competing fiercely for market share. With Chong Kun Dang and Kwangdong preparing to launch generics, the market landscape is expected to become even more complex.

A pharmaceutical industry insider analyzed, “Given the high commercial potential of the product, generic companies are continuing to challenge the patents. With Chong Kun Dang and Kwangdong securing generic exclusivity, the generic market is highly likely to evolve into an initial two-horse race starting in 2033