Janssen’s acetaminophen tablets may replace Tylenol

Janssen’s acetaminophen tablets received import authorization in Korea

Same product as the Tylenol 500mg that are locally manufactured

Sales surge due to COVID-19 vaccinations… measures made in preparation of the Hyangnam plant shutdown

Janssen Korea, which locally manufactures and sells Tylenol in Korea, has received import authorization for its product.

 

The company is presumed to be making the move to secure alternatives in advance before stopping the operation of its Hyangnam plan at the end of this year.

 

On the 23rd, the Ministry of Food and Drug safety approved Janssen’s import of acetaminophen tablets that contain the antipyretic analgesic ingredient, ‘acetaminophen.’ The product is identical in ingredient, strength, and formulation to the Tylenol 500mg tablets that are locally made by Janssen.

 

With the surge in demand for Tylenol 500mg as a means to relieve the side effects of COVID-19 vaccinations, the drug has made the highest sales performance among all OTC drugs.

 

A large amount of the Tylenol tablets that are currently in the market are known to be stockpiled items that were produced in preparation for the shutdown of Janssen's Hyangnam plant.

 

With the amount in the market being rapidly depleted, the amount left in stock after the shutdown of the Hyangnam plant may be less than expected.

 

This was why a new product from a new manufacturing facility had to be secured in advance for import.

 

Jannsen’s acetaminophen tablets that will be imported will be those that are manufactured in Indonesia and are expected to replace the Tylenol 500mg tablets that are being manufactured in the company’s Hyangnam facility.

 

One thing to note is that the company did not use the brand name ‘Tylenol,’ but rather listed its generic name in the import authorization.

 

This is noteworthy as pharmacies in Korea had trouble securing Tylenol after the Korean authorities had mentioned the specific brand name as a treatment for COVID-19 vaccine’s side effects.

 

However, this may only be due to the fact that Janssen’s marketing authorization for the brand name in Korea is still in place.

 

The industry expects that the company will consider changing the generic name authorization to the brand name after the company withdraws its license for the Hyangnam plant's Tylenol.

 

The dominant opinion is that it will not be easy for the company to give up the name because of the high brand recognition.

 

As such, Janssen has been preparing alternative products in preparation for the Hyangnam plant shutdown.

 

Janssen’s ‘Ultracet Set Tab,’ which is a combination of acetaminophen and tramadol hydrochloride, has also been granted import authorization.

 

Technology transfer for the extended-release formulation of the Ultracet brand has been made to a domestic pharmaceutical company, Handok.

 

As there are many products in the Tylenol brand, these are also expected to undergo technology transfers or be switched to imports.

 

Therefore, 'Tylenol' manufactured from Janssen's Hyangnam plant will not be seen in the market from next year.

 

Established in 1983, Janssen’s Hyangnam plant was one of the few manufacturing bases established by multinational pharmaceutical companies.

 

Hwanin Pharmaceutical acquired the facility in November last year at 46 billion won, and Janssen will be withdrawing its plant that had been in operation for 38 years.