Hanmi’s salt-modifying drug for Galvus, re-licensed

Strategic turn due to failure to split indications, aiming for early release due to invalid extension of duration

As a result of the first patent challenge, it was invalidated for 187 days, and the second was reduced to 55 days

Hanmi, which failed to enter the market for Vildagliptin through so-called split indications, has obtained item approval again.

 

The MFDS approved Vildagle Tab 50mg (Vildagliptin HCl) by Hanmi on the 10th.

 

It was licensed in January of last year, and Vildagle Tab 50mg, which was voluntarily withdrawn in July of that year.

 

The withdrawn item is used as an adjunct to diet and exercise therapy to improve blood sugar control in type 2 diabetes patients.

 

It was approved for four types of treatment: ▲ single therapy ▲ Metformin combination therapy ▲ Sulfonylurea and Metformin combination therapy ▲ Insulin alone or Metformin combination therapy.

 

However, in addition to the four methods of use, this product has added sulfonylurea or metformin or thiazolidinedione co-administration.

 

The scope of efficacy and effect has become the same as the original drug, Novartis' Galvus.

 

Hanmi previously established a Galvus patent avoidance strategy with a product with a reduced range of usage.

 

Insurance benefits were obtained, but the strategy needed to be revised because he lost the patent lawsuit.

 

It was withdrawn, and re-approval was obtained with the same efficacy and effect this time.

 

In the case of Vildagliptin, original Novartis products and products by Ahn-Gook and Hanmi are licensed.

 

Ahn-Gook's product is Vildagliptin, the same as the original Galvus.

 

Ahn-Gook acquired generic exclusivity through the success of the first patent challenge, and the sale of the same active ingredient was banned from August 30, 2021 to May 29, 2022, but Hanmi's salt-modifying drug for Galvus is not applied.

 

Not only Ahn-Gook, but also Hanmi succeeded in the first patent challenge, but did not succeed in the second patent challenge.

 

In the first (the KIPO) challenge, Galvus' material patent period was reduced by 187 days through a trial for invalidation of the extended duration, but in the second (Patent Court of Korea) challenge, only 55 days were recognized as invalid.

 

Therefore, it must be released later than in August this year, which was originally planned for the release date.

 

It is a burden that other generics are developing their products in line with the material patent end date of March 4, 2022.

 

This is because it is advantageous to preoccupy the generic market by promoting product release as much as possible.

 

Currently, Ahn-Gook and Hanmi's patent challenge was contested in the Supreme Court due to Novartis' appeal.

 

Depending on the final outcome of the Supreme Court, the strategies of the two companies to dominate the market are expected to change.