Hanmi’s generic for Galvus is aiming for release next year

as a salt-modifying drug

The result of the judgment on the extension of the duration scheduled for the 29th is important

Galvus by Novartis

Hanmi applied for item approval again three months after withdrawal of the DPP-4 inhibitory diabetes treatment 'Galvus' (Novartis, Vildagliptin) salt-modifying drug.

 

Indications were not removed unlike existing products, and combination drugs were applied for permission.

 

According to the MFDS and pharmaceutical industry on the 21st, Hanmi applied for item approval for a single drug for Vildagliptin HCl on the 29th of last month and a combination drug for Vildagliptin HCl /Metformin HCl on the 16th of this month.

 

In January, Hanmi obtained an item license for Vildagliptin HCl.

 

At the time, it was licensed to exclude two of the original drug uses.

 

The company tried to obtain insurance benefits, but the Intellectual Property Trial and Appeal Board dismissed the request from Hanmi.

 

Accordingly, as of July 6, Hanmi voluntarily withdrew the item.

 

The item applied for permission this time contains the same six original uses unlike the previous case.

 

It seems that it is now aiming for release on August 30th next year.

 

Although it failed to split the indications, Hanmi and Ahn-Gook succeeded in invalidating Galvus' material patent duration extension period of 187 days.

 

Accordingly, the product can be released on August 30 next year.

 

However, in response to the Intellectual Property Trial and Appeal Board trial decision, Novartis has filed a lawsuit to cancel the trial decision to the Patent Court of Korea.

 

The judgment of this lawsuit is scheduled for the 29th this month.

 

It will be difficult to launch in August next year if the court takes the side of Novartis, then, it will be available only in March 2022, a year later.

 

Hanmi applied for permission for the Metformin combination drugs at this time.

 

Currently, Hanmi is the only generic company that has applied for a combination drug.

 

Although it failed to launch this year, it can dominate the market with Ahn-Gook even if it is released next year.

 

However, Ahn-Gook did not apply for a combination drug.

 

It is analyzed that if Hanmi introduces a single drug and a combination drug at the same time, it will be more advantageous in the competition for market share of generic companies.

 

According to UBIST in the first half of this year, the outpatient prescription sales of the original, Galvus and the combination drug, Galvusmet were ₩4 billion and ₩17.9 billion, four times larger in the combination drug market.