Six pharmaceutical companies challenge the 'Esgliteo' patent

targeting diabetes combination therapy

Six companies, including Boryung, filed claims for passive trials to confirm the scope of a right…they are also challenging the nullification trial

Esgliteo recorded the highest prescription amount among combination therapies containing SGLT2i+DPP4i for treating diabetes…will there be additional challenges?

Generic companies have claimed patent challenges against Boehringer Ingelheim’s combination therapy for diabetes, 'Esgliteo (empagliflozin+linagliptin).' It is the strategy of six companies, including Boryung, to launch their generics early by avoiding or nullifying the patent of this combination therapy, which contains SGLT-2 inhibitor and DPP-4 inhibitor ingredients.

 

According to pharmaceutical industry on May 28th, the six companies, including Boryung, Dongkook Pharm, Aprogen, Korea Prime Pharm, and Daehwa, filed claims for passive trials to confirm the scope of a right involving the Esgliteo patent.

 

These companies also filed a claim for a nullification trial for the same patent.

 

In the case of a nullification trial, Genuonesciences has already filed a claim for a trial last month.

 

Consequently, generic companies are challenging both avoidance and nullification of a single patent.

 

Esgliteo is protected by the patent titled 'A pharmaceutical composition including glucopyranosyl-substituted benzene derivatives' until August 2028.

 

However, this patent is not listed on the Ministry of Food and Drug Safety (MFDS) list.

 

This strategy is similar to that of Boehringer Ingelheim, where Jardiance (empagliflozin) and Trajenta (linagliptin) were not patented.

 

The companies challenging patents aim to launch their generics after either avoiding or nullifying the Esgliteo patent.

 

Since they are challenging a single patent with two approaches simultaneously, the analysis indicates that they are eager to overcome the patent.

 

The generic version of linagliptin is expected to launch after the Trajenta substance patent expires next month.

 

If the companies successfully challenge Esgliteo patent, they can expand their portfolio of linagliptin-based combination therapy.

 

The remaining hurdle is the possibility of an unregistered patent.

 

Similar to the cases of Jardiance and Trajenta, there may be unregistered patents.

 

The analysis suggests that the product approval is not affected by the remaining unregistered patent challenge, but there may be a patent infringement possibility when products are launched.

 

Meanwhile, Esgliteo has the highest prescription sales among combination therapies, consisting of SGLT-2 inhibitor and DPP-4 inhibitor, for diabetes.

 

According to market research firm UBIST, Esgliteo a generated prescription amount of KRW 2.7 billion.

 

This is higher than KRW 2.2 billion of LG Chem’s 'Zemidapa (dapagliflozin+gemigliptin),' KRW 2.1 billion of AstraZeneca’s 'Qtern (dapagliflozin+saxagliptin),' KRW 600 million of CKD Pharm’s 'Exiglu S (dapagliflozin+sitagliptin),' and KRW 500 million of Dong-A ST’s 'Sugadapa (dapagliflozin+evogliptin).' Esgliteo generated KRW 2.5 billion this year in the first quarter, similar to last year’s annual prescription performance.

 

The pharmaceutical industry anticipates that other generic companies may challenge the patent additionally because Esgliteo sales are rapidly increasing.