Competition for generics for Tenelia M SR is fierce

Beginning with Mothers Pharm, start phase I clinical trial in Kyung Dong & Kolmar Korea

Tenelia M is superior to Tenelia in market performance

Tenelia M SR

Following Handok's DPP-4 inhibitory diabetes treatment 'Tenelia', the generics for 'Tenelia M SR', a combination drug combined with Metformin, are also actively developing commercialization.

 

According to the MFDS on the 20th, this year, Kyung Dong and Kolmar Korea were approved for a phase I clinical trial to compare the equivalence of their developed drug and Tenelia M SR.

 

Kyung Dong received approval of two clinical trial protocols in July and August, and Kolmar in August and October.

 

The reason for the two trials is that Tenelia M SR is a drug that controls blood sugar both before meal and after meal by taking once a day.

 

Therefore, Kyung Dong and Kolmar Korea conduct a test to compare the bioequivalence of healthy adults in two situations before and after meals.

 

Previously, Mothers Pharm was also approved for clinical trials in two situations before and after meals in October last year.

 

Until now, Tenelia salt modification single drug product approval and application for permission are continuing, but it is known that there is no approval procedure for the combination drug Tenelia M SR.

 

It is still in the stage before commercialization.

 

A single drug was applied for the first approval of a product containing Teneligliptin HCl, a salt-modifying drug, in April, and Kyungdong received the first approval of 'Teneritin Tablet 20mg' with the same ingredient last month.

 

In addition, five additional Teneligliptin HCl hydrates have been applied for permission, and two cases of 'Teneligliptin tosylate hydrate'' have been applied for permission.

 

Both drugs were reportedly developed by Kyung Dong and Mothers Pharm.

 

The ingredient name of Tenelia is Teneligliptin hydrobromide hydrate.

 

Teneligliptin's substance patent expires on October 25, 2022, so generics cannot be sold until then.

 

In addition, a separate composition patent for Tenelia M SR is scheduled to expire on December 23, 2034.

 

There are still no generics for composition Patent.

 

Tenelia is a product introduced by Handok by 'Mitsubishi Tanabe Pharma' in Japan.

 

However, Tenelia M SR is a product developed by Handok as a combination drug after the introduction of Tenelia.

 

The combination drug Tenelia M SR outperforms the single drug Tenelia.

 

Based on UBIST, Tenelia M SR's outpatient prescriptions in the first half of this year were ₩10.8 billion and Tenelia’s sales were ₩9.5 billion.