Korea United Pharm's Galvusmet generic is the first approved

will compete with Hanmi Pharmaceutical in the latecomer market

Outpatient prescription market last year amounts to ₩36 billion

opportunity to preoccupy market through rapid development

Korea United Pharm received approval for the first generic of Novartis’s DPP-4 inhibitor, ‘Galvusmet (vildagliptin/metformin hydrochloride),’ an antidiabetic treatment.

 

With the approval, the company will likely be competing with Hanmi Pharmaceutical next year, which marked the start of Galvusmet latecomers with a salt-modified drug in July.

 

The Ministry of Food and Drug Safety approved Korea United Pharm’s Galvusmet generic on the 18th.

 

The product is a fixed-dose combination of vildagliptin and metformin hydrochloride and is a generic drug that contains the same ingredient as Novartis’s Galvusmet that was approved in 2008.

 

The drug was approved as an adjunct to diet and exercise to improve glycaemic control in type 2 diabetes patients that are eligible to take the vildagliptin+metformin combination.

 

With the substance patent for the single-agent drug Galvus and combo Galvusmet to expire on March 4th of next year, companies of latecomer drugs are accelerating development to preoccupy the patent-expired market.

 

Twelve companies including Ahn-Gook Pharmaceutical, Ahngook New Pharm, Hanmi Pharmaceutical, Genuone Sciences, LitePharmTech, White Life Science, PharmGen Science, Mother’s Pharmaceutical, Daewoong Bio, Dongkoo Bio&Pharma, KyungBo Pharm, GL Pharma have already received approval for latecomer single-agent vildagliptin products.

 

Among the companies, Ahn-Gook Pharmaceutical and Ahngook New Pharm succeeded in avoiding the original's patent by challenging part of the term extended for the substance patent of Galvus and achieved generic exclusivity from January 9th to May 29th.

 

Therefore, other drugs with the same vildagliptin ingredient as those approved by Ahn-Gook Pharmaceutical and Ahngook New Pharm cannot be sold during the term.

 

However, drugs with a different salt ingredient are not considered identical and are not subject to sales restrictions.

 

Also, the vildagliptin/metformin combination agents are also not subject to sales restrictions under Ahn-Gook’s generic exclusivity.

 

Until now, only Hanmi Pharmaceuticals and Korea United Pharm received approval for a latecomer combination drug.

 

However, Hanmi Pharmaceuticals’ product is a salt-modified drug and not a generic of the same ingredient.

 

Hanmi and United succeeded in avoiding the composition patent of Galvusmet through a passive trial to confirm the scope of rights and may start the sale of their products after the original’s product patent expires.

 

In other words, the companies may sell their products without any issue from March 4th.

 

In addition, if the companies receive a ruling confirming the ruling made by the Patent Court of Korea in the trial to invalidate the extended period of substance patent that is pending in the Supreme Court, the companies may be able to sell their drugs from January of the next year.

 

The trial is currently ongoing between Novartis, the patent holder, and the latecomer companies, Ahn-Gook Pharmaceutical and Hanmi Pharmaceutical.

 

As Hanmi and United had received approvals of their respective drugs before October, they may even be able to release their products with insurance benefit in January.

 

Therefore, the two companies are expected to compete fiercely to preoccupy the market.

 

By market size, the Galvusmet has a much larger market than the single-agent Galvus.

 

According to UBIST, outpatient prescription sales of the drugs last year was ₩8.1.

 

billion for Galvus and four times higher - ₩36.4 billion - for Galvusmet.

 

With rapid commercialization being the key to preoccupying this immense Galvusmet latecomer market, Hanmi and Korea United Pharm seem to have taken a lead.