Generic SPC therapies challenge 'Trajenta'

10 pharmaceutical companies in Korea challenge 7 patents yet to be listed in 6 months

The case, if won, could trigger the early release of 'Linagliptin+Dapagliflozin' next year

Product photo of Trajenta

Major generic companies are challenging the unlisted patent of 'Trajenta (linagliptin)', a DPP-4 inhibitor-based diabetes treatment.

 

For 6 months since last September, 10 pharmaceutical companies have successively filed trials on 7 patents.

 

It is believed that the companies are aiming for the release of Trajenta generics and Trajenta+Forxiga (dapagliflozin) combination products, as the product patent expires next year.

 

According to the pharmaceutical industry, Sinil Pharmaceutical, Hutecs Korea Pharmaceutical and Hanlim Pharm recently simultaneously filed a defensive confirmation trial for the scope of rights and invalidation trial on three unlisted patents, on the 24th.

 

The patents are for separate formulation patents that expires in April 2027.

 

Since last September, challenges to unlisted patents of Trajenta have been continuing.

 

In September of last year, Genuone Sciences have first filed for a defensive confirmation trial for the scope of rights against a formulation patent that expires in April 2027.

 

Since then, Korea United Pharm, Korea Biochem Pharm, Sinil Pharmaceutical, Hutecs Korea Pharmaceutical, Hanlim Pharm, etc.

 

have joined the challenge.

 

In last October, Genuone Sciences, Boryung, Mother's Pharmaceutical, Kukje Pharm, and GC Biopharma have filed for invalidation trials against three different use patents of Trajenta, which expires in May 2027.

 

In the last 7 months, 10 generic companies have challenged 7 unlisted patents of Trajenta.

 

The patents are not listed in the Ministry of Food and Drug Safety Patent List.

 

From the generic companies' standpoint, there is no problem in obtaining approval for a generic without challenging the patents.

 

However, the matter becomes different when it comes to releasing an actual product.

 

Administratively, it is possible to release a product at the time of the expiration of the patent, but there is a risk of being involved in a patent infringement lawsuit with the company of the original product.

 

If the original company files for a patent infringement lawsuit as well as an injunction to prevent the release of the general product, the release date of the product may be delayed.

 

This is because if the patent infringement lawsuit is lost, it could lead to a damages suit.

 

It seems that the generic companies are challenging unlisted patents of Trajenta to resolve such uncertainties.

 

If they succeed in avoiding or invalidating the unlisted patents of Trajenta, it could trigger the early release of generics after the product patent of Trajenta expires in June next year.

 

In 2015, generic companies simultaneously challenged the crystalline form patent and product patent of Trajenta.

 

However, they failed to overcome the product patent.

 

The companies plan to release generics in June next year, as the product patent of Trajenta expires.

 

The fact that the patent for Forxiga, an SGLT-2 inhibitor-based diabetes treatment, expired in March also seems to be a reason why generic companies are challenging an all-out attack on the unlisted patents of Trajenta.

 

As reimbursement has recently been applied to DPP-4 inhibitors, SGLT-2 inhibitors and Metformin combination triple therapies, the combination therapy of such ingredients are expected to attract tremendous attention in the prescription drug market.

 

It is expected that the generic companies will be releasing combination products of 'Linagliptin+Dapagliflozin' as the patent for Trajenta expires.

 

Among major DPP-4 inhibitor-based diabetes treatments, the patents for Norvatis's Galvus (Vildagliptin) and Handok's Tenelia (Teneligliptin) have been expired.

 

However, generic companies have been greatly interested in Januvia (Sitagliptin) and Trajenta, as the two were ranking first and second in the prescription drug market among the existing DPP-4 inhibitors.

 

The product patent for Januvia will be expired in September this year.

 

According to UBIST, a pharmaceutical market research institute, the prescription amount of Trajenta last year was KRW 64.2 billion.

 

Trajenta Duo, in which metformin was added to Trajenta, recorded a prescription performance of KRW 68.3 billion.