The number of generics has been the lowest in 7 months

Since the launch of Atozet’s generics

The number of Rx drugs' generic licences is the lowest in seven months since October last year.

 

Recently, it was released in large numbers of generics for Atozet, but it fell back to its level shortly after the implementation of the drug price system.

 

The proportion of consigned generics, which exceeded 80%, also fell to 50%.

 

According to the MFDS on the 10th, the number of generics for Rx drugs was 44 last month.

 

It is down 62% in a month from 116 in April.

 

The figure is the lowest in seven months since 43 generics were licensed in October last year.

 

The number of generic permits surged this year, but it plunged to the level in the second half of last year.

 

In January, 102 generics were licensed and in February, 375 were licensed.

 

In March and April, 177 and 116 generics were licensed, respectively.

 

The reason for the surge in permits for generic products earlier this year is because of generics for Atozet.

 

In February alone, 89 pharmaceutical companies were licensed a total of 256 of combinations of Atorvastatin and Ezetimibe.

 

It is generic of Atozet sold by MSD and Chong Kun Dang.

 

After Atozet's re-examination period expired on January 22, it applied for permission and received approval for sale at the same time.

 

In February, 44 generics of MSD's diabetes drug Januvia were also licensed.

 

However, as the number of Atozet's generic permits has decreased, the number of generic permits has dropped sharply.

 

According to trends in number of licenses for generics, it has surged since early 2019 and slowed down in second half of last year.

 

A total of 5,488 generics were licensed from January 2019 to May last year, averaging 323 per month.

 

In 2018, a total of 1,110 generics were licensed, with an average of 93 per month.

 

The number of permits has more than tripled in a year.

 

The government's move to tighten generic regulations led to a surge in generic permits.

 

The reorganized drug price system, which took effect in July last year, can maintain an upper limit of 53.55% compared to the original drug before the expiration of the patent only when generics meet both biological equivalence tests and use of registered raw materials.

 

The system includes a stair-type drug price system in which the upper limit is lowered as the time for registration is later.

 

If more than 20 generics are registered in Rx market, the upper limit of the newly registered items will be up to 85% of the existing lowest price.

 

Since the implementation of the system, generic permits have been significantly reduced.

 

The number of generic licenses, which reached 427 in May last year, fell to 73 in June.

 

An average of 58 generics per month entered in seven months, including 74 in July, 51 in August, 45 in September, 43 in October, 58 in November and 69 in December last year.

 

The average number of generic permits per month in the previous year and a half has been reduced to 18%.

 

Until May last year, products that applied will be subject to previous drug price system.

 

Generics, which has been approved since June and applied for the registration, receives low drug prices due to the new drug price system.

 

This is why the number of new generic permits has plummeted since June.

 

Among generics that were approved from October to December last year, 26%, 38%, and 70%, respectively.

 

It rose to 82% in January this year, and recorded 85% in February-April, 80% and 78%.

 

Last month it fell to 50%.

 

It is the lowest level since November last year.

 

The industry expects the number of generic licenses to vary depending on the opening of large new generics markets such as Atozet.

 

In the case of Atozet, there was a large price deviation depending on the timing of the permit because it was newly formed.

 

As drug prices fall depending on the timing of entry into the market, simultaneous competition for permits has been carried out.

 

Competition for first generic to preoccupy drug prices is expected to be fierce because drug prices will be lower depending on the timing of entry into generic.