KB Pharm's generic for Vildagliptin nitrate will be approved

for the first time

It is expected to be released early next year

The post-inflammatory drugs of the diabetes treatment Galvusmet (Vildaglipin-Metformin Hydrochloride), which the Supreme Court ruled invalidating part of its extended duration, are appearing one after another.

 

These items will be able to be released early in January next year if some of their duration is confirmed to be invalid.

 

On the 30th of last month, three dosage products of Vildagliptin-Metformin HCl, a compound of KB Pharm, were approved.

 

It is the seventh company to launch generic for Galvusmet.

 

However, this is the first salt-changing drug containing Vildagliptin nitrate.

 

Pharmaceutical companies participated in the development one after another.

 

At first, only An-gook and Hanmi Pharm, which claimed invalidation of their duration, were developed, but when the Patent Tribunal achieved results, KOREA UNITED PHARM and KB Pharm also participated in the development.

 

The lawsuit for invalidation of the extension of the duration ended on October 28 when the Supreme Court recognized 55 of the 1,068 extended days as invalid.

 

If some of the invalidity of the duration is finalized, material patent of Galvusment will expire on January 9 next year.

 

In this case, other pharmaceutical companies that have not participated in the lawsuit can also launch products on the market as their substance patents are terminated.

 

Currently, generics for Galvusmet have been approved by Hanmi Pharm, KOREA UNITED PHARM, Ahn-gook, Ahn-gook Newpharm, Shinpoong, Samjin, and KB Pharm.

 

However, Hanmi Pharmaceutical and KB Pharm are the only pharmaceutical companies that have been approved for three doses.

 

The rest of the pharmaceutical companies were granted only 50/500 mg.

 

In the case of generic for Galvusmet, there are no restrictions on selling products because there are no products that have received general for inclusion.

 

In the case of single-drug Vildagliptin, Ahn-gook Newpharm has acquired generic for exclusivity, and the same drug will be banned from selling until May 29, 2022.

 

Last year, Galvusmet recorded 36.4 billion won in outpatient prescriptions, continuing its popularity in the diabetes treatment market.

 

Competition is expected to intensify when the generic market opens next year.