Choline alfoscerates, 82 generics were approved last year

Despite the controversy over the effectiveness

Interested in reimbursement restrictions

The most representative of choline alfoscerates

Despite the controversy over last year's efficacy, choline alfoscerate formulations were found to have received 82 new licenses last year.

 

Only 267 cumulative licensed items are available.

 

On the 9th of last year, an investigation into the approved items of the same ingredient was conducted through MFDS' website.

 

The choline alfoscerate formulation was found to have a validity issue during a national audit last October.

 

In response, the Ministry of Health and Welfare announced plans to conduct a pay reevaluation by June this year, and the MFDS began validating in November.

 

The industry believes that choline alfoscerate's reimbursement restrictions are strong.

 

Nevertheless, pharmaceutical companies considered the high marketability of the formulation and continued to produce the product.

 

Choline alfoscerate formulations form a large market with insurance claims amounting to about ₩300 billion.

 

Irrespective of the size of hospitals and majors, the elderly are indiscriminately prescribed for the prevention of dementia.

 

It is a perfect market for domestic pharmaceutical companies that do generic sales in the parliamentary market.

 

In addition, consignment items poured out last year as new formulations such as liquid In hard capsules and syrups, which can be bottled, were released.

 

Choline alfoscerate formulations, despite no original patent expiration issues last year, recorded a number of licensed items following Pregabalin (93) and Oseltamivir (87).

 

Major generic drug licenses in 2019

Pregabalin and Oseltamivir formulations have recently expired.

 

However, Pregabalin has three doses, and Oseltamivir is difficult to make an indirect comparison in that there are three capsule dosage forms and a suspension formulation.

 

The MFDS is currently validating Choline alfoscerate preparations, but it is difficult to draw conclusions.

 

Since it has already been validated through the 2018 update, it is difficult to conduct clinical reevaluation due to lack of literature data.

 

However, the industry reports that reimbursement revaluation may result in reimbursement restrictions in order to reduce consumption.