CKD and Kwang Dong win Tagrisso formulation patent suit

Green light lit for its early launch

Product launch possible after Tagrisso’s 2033 substance patent expiry

Generic drugmakers challenging AstraZeneca's patent for the non-small cell lung cancer treatment ‘Tagrisso (osimertinib)’ have won their case in the first instance.

 

According to industry sources on the 25th, the Intellectual Property Trial and Appeal Board (IPTAB) on the 24th ruled in favor of Chong Kun Dang and Kwang Donng Pharmaceutical in their request for a negative right scope confirmation trial regarding Tagrisso’s formulation patent (No.

 

10-2336378).

 

This significantly increases the possibility of an early launch of Tagrisso generics.

 

The two companies have also met 2 key requirements for obtaining exclusive marketing rights (first generic exclusivity): ▲ being the first to file the trial request and ▲ winning the trial/litigation.

 

Now, they only need to satisfy the condition of being the first to file for generic approval to obtain the first generic exclusivity right.

 

CKD and Kwang Dong are the only companies to have challenged the Tagrisso formulation patent.

 

If both secure the first approval for their generics and gain the first generic exclusivity rights, they will be able to sell their product exclusively for 9 months.

 

The key variable is AstraZeneca’s appeal.

 

If AstraZeneca files a lawsuit to overturn the IPTAB decision with the Patent Court, the dispute may be prolonged.

 

AstraZeneca's decision on whether to appeal has not yet been made.

 

Tagrisso is protected by three patents: substance patents expiring in November and December 2033, and a formulation patent expiring in January 2035.

 

CKD and Kwang Dong have successfully avoided the formulation patent.

 

With the formulation patent out of the way, both companies plan to launch their generics as soon as the substance patent expires in 2033.

 

There is also speculation that they could aim for an even earlier launch by targeting the extended duration granted to the substance patent.

 

Tagrisso is a targeted anticancer drug used for EGFR-mutated non-small cell lung cancer (NSCLC) that received domestic approval in 2016.

 

It is used as a first-line treatment for patients with locally advanced or metastatic NSCLC harboring EGFR gene mutations.

 

In Korea, it competes with Yuhan Corp’s Leclaza (Lazertinib).

 

According to the market research institution IQVIA, Tagrisso’s sales in Korea reached KRW 111 billion in 2023.

 

After surpassing KRW 100 billion in annual sales in 2022, growth has continued steadily.

 

With reimbursement expanded last year to include first-line treatment for locally advanced and metastatic NSCLC patients with specific EGFR mutations, sales are estimated to have exceeded KRW 130 billion.

 

Separately, CKD is developing its own new drug for non-small cell lung cancer.

 

The candidate compound, named ‘CKD-702’, is a bispecific antibody targeting both cMET and EGFR.

 

It is currently undergoing global Phase I clinical trial.

 

CKD is seeking to strengthen its foothold in the NSCLC treatment market by developing both a new drug and a generic.