Generics for Galvus, focus on development strategy

to avoid exclusivity for generic product

Challenge patents with different billing methods including development SR tablets

Ahn-gook is advantageous because they obtained item approval and successful patent challenge

노바티스 <가브스>

The development of generic drugs for Galvus (Vildagliptin by Novatis Korea), which is a DPP-4 inhibitor for diabetes mellitus is continuing.

 

In particular, while Ahn-gook pharmaceuticals and Hanmi Pharmaceuticals have already completed their commercialization and anticipated market preoccupation, pharmaceutical companies' strategies to penetrate this gap and enter the market early on are drawing attention.

 

According to the MFDS and the industry, pharmaceutical companies that are currently developing generics for Galvus include Ahn-gook Pharmaceuticals, Hanmi Pharmaceuticals, Korea United Pharm, inc, Kolmar Korea, and Alvogen Korea.

 

The generic drug Angukvildaliptin tablets 50mg by Ahn-gook Pharmaceuticals approved on 22nd last month.

 

Hanmi Pharmaceuticals also applied for a salt alteration drug in last July.

 

Ahn-gook pharmaceuticals and Hanmi pharmaceuticals laid the groundwork for the market by the end of August 2021, citing a request for an extended trial invalidation filed in the Galvus material patent.

 

In addition, both companies have a strong chance of obtaining a preferential selling license to monopolize the generic market for nine months.

 

Both companies which have the rapid speed of patent challenge and commercialization has increased the likelihood to obtain benefit of first generics.

 

Given this scenario, it is likely that other pharmaceutical companies except for Ahn-gook & Hanmi which are likely to get exclusivity for generic product , will enter the market late.

 

But second-runners, Korea United Pharm, inc, Kolmar Korea, and Alvogen Korea.

 

also have the opportunity to accelerate their time to market.

 

They are developing generics for Galvus late for that niche market.

 

In order to avoid the sale ban period under exclusivity for generic product of Ahn-guk and Hanmi, they must prevail over revised drugs such as salt changes, slow-release drugs, or through appeals of different nature.

 

Korea United Pharm, inc, which received approval for the bioequivalence test plan last September, and filed a patent trial earlier last month, is conducting patent trials in a manner other than the successful patent challenge method of Ahn-guk and Hanmi.

 

If Ahn-guk & Hanmi succeeded in the patent challenge through the extended period of invalidity trial, Korea United Pharm, inc raised the right to confirm the scope.

 

There are different kinds of judgments, but there are similar aspects in attempts to neutralize extended durations.

 

However, due to the different methods of patent challenge, if Korea United Pharm, inc wins the Scope of Rights Judgment, it could be a new exclusivity for generic product vendor.

 

However, there is a premise that the company must win the referee.

 

Alvogen Korea was approved last month on the bioequivalence protocol, which identified the drug as Vilagliptin sustained release tablets.

 

In some cases, Galvus may be administered twice daily, and Vildaliptin sustained-release tablets appear to be a reduced version of the drug once daily.

 

In any case, if sustained-release tablets are commercialized, they will be able to plan early market launches in their own way, regardless of previous generic patents.

 

Kolmar Korea, who was approved for a bioequivalence test on the 25th of last month, has yet to disclose how to circumvent exclusivity for generic product because there is no patent challenge.

 

However, there is an observation that it is asking for a passive jurisdiction judgment like Korea United Pharm, inc.

 

What's important is that latecomers such as Korea United Pharm, inc, Kolmar Korea, and Alvogen Korea will have to succeed in product development and win a patent challenge in order to evade exclusivity for generic product and enable early release scenarios.

 

So far, only scenarios have emerged, making it most likely that a licensed Ahn-guk will have a monopoly in the generic market.

 

There are only nine new DPP-4 inhibitors, and competition among companies is fierce, but it is not open to generics.

 

Among them, Vilagliptin formulations for Galvus are likely to become the first generic product in the DPP-4 inhibitor market.