Yooyoung will newly release repackaged flagship Pravafenix

Voluntarily withdraws its existing marketing authorization... renewed product to be listed with reimbursement in October

Yooyoung Pharmaceutical has voluntarily withdrawn the marketing authorization for its product, ‘Pravafenix Cap’, as the product is due for a packaging renewal.

 

As a flagship product, Pravefenix Cap has been recording annual sales of approximately 20 billion KRW.

 

The newly self-packaged product is expected to be listed for reimbursement this upcoming October.

 

According to the industry, Yooyoung Pharmaceutical voluntarily withdrew its permit for Pravafenix Cap (pravastatin+fenofibrate) on the 18th.

 

This comes 11 years after the company first received approval in July of 2012.

 

The drug is a treatment for dyslipidemia, imported from the Belgian pharmaceutical company, SMB.

 

Since then, the drug has settled as a flagship item and has long served as Yooyoung's cash cow.

 

Based on UBIST, the drug reached an outpatient prescription sales of 21.4 billion KRW last year.

 

Considering Yooyoung’s total sales being approximately122.1 billion KRW last year, Pravafenix accounted for a high proportion of the company’s total sales.

 

The company received approval for ‘Yooyoung Pravafen Cap’ in February before withdrawing its approval for the existing Pravafenix.

 

In the past, Yooyoung imported Pravafenix from SMB as fully packaged finished goods under an import permit.

 

The new manufacturing approval for Pravafenix allows for the company to import the capsules in bulk and package the products at Yooyoung’s manufacturing facility.

 

The company explained that this decision was made to flexibly respond to market demands.

 

The newly packaged drug is expected to be listed for reimbursement in October.

 

A company official stated that Yooyoung voluntarily withdrew the import permit in order to use the trademark “Pravafenix Cap”, as for the MFDS would not allow two authorizations under identical names.

 

The product name of the new manufactuiring approval has been changed from “Pravafen Cap” to “Pravafenix Cap”.

 

He added, "The newly released Pravafenix Cap is expected to be reimbursed from October, however reimbusment may be claimed for the original Pravafenix Cap as well during a short overlapping period in order to minimize supply interruptions.

 

Although some domestic companies are developing generic versions of Pravafenix, there has been no news of an item receiving marketing authorization yet.