Annual sales↑to ₩6.5 billion by generic exclusivity

Drug costs decrease by up to ₩ 4.7 billion, original company damages up to ₩11.3 billion

2018 Impact Assessment Results, Employment increases by 38 people

Myung-jin Chung, director of KHIDI, is announcing the results of the impact assessment on the patent linkage

According to a survey result, the drug costs in 2018 were reduced by up to ₩4.8 billion due to generic drug exclusivity.

 

Sales of generic pharmaceutical companies increased by up to ₩6.5 billion while the original company's drug costs were reduced by ₩11.3 billion.

 

Myung-jin Chung, general manager of KHIDI, announced the results of the four-year impact assessment of the Patent linkage at the '2019 Drug Licensing Patent Linked System Policy Forum' held at the Four Points Hotel, Seoul Guro on the 19th.

 

The impact assessment of the patent linkage began in 2016 under the applicable Act and was the fourth time this year.

 

The study period was from April to October of this year, and the study was conducted on drugs that received prohibition of sale or generic exclusivity from January 2018 to December 2018, and their disposal were terminated (expiration of the period, expiration of effect, etc.).

 

During this period, there were 29 items in generic exclusivity, and the targeted brand listed drugs were 5 items.

 

The representative generic exclusivity drugs include 10 generic products of the osteoarthritis named “Layla” and 14 generic products of the hepatitis B named “Viread”.

 

As a result, early entry effect of late drug market was 1.3 ~ 4.6 months.

 

Early entry effect was based on 9 months from the date of notification to the original company following the application for the permission of generic exclusivity.

 

If the original company asks for a prohibition of sale under the patent linkage system, it will not be able to enter the market for 9 months.

 

The sales of generic companies, which acquired the generic exclusivity, increased from ₩5.696 billion to ₩6.473 billion.

 

On the other hand, targeted pharmaceutical companies with the original listed drugs declined from a minimum of ₩9.9 billion to sales of ₩11.3 billion.

 

In the case of Viread, pharmaceutical companies with listed drugs declined from ₩6.2 billion to ₩7.6 billion.

 

On the other hand, Generics sales increase from ₩3.4 billion to ₩4.2 billion.

 

As a result, the drug costs have been reduced from ₩4.53 billion to ₩4.76 billion.

 

The indirect effect of generic exclusivity items is an increase in the research development costs and employment.

 

According to the research results, the R & D expenditure increased from minimum of ₩180 million to maximum of ₩360 million.

 

Employment also increased from a minimum of 19 people to a maximum of 38 people.

 

Myung-Jin Chung said, "Prior to the 4th year after the implementation of the system, the approval of generic exclusivity has had a positive effect on the domestic pharmaceutical industry and health policy." He added.

 

“Unlike concerns when introducing the system, original companies don't apply the prohibition of sale much.

 

Activation of the genetic exclusivity has led to a rise in sales of domestic pharmaceutical companies.