Six more Arcoxia generics acquire generic exclusivity

A total of 10 products to be exclusively sold in the generic market until December… attention is on how it will impact in the analgesic market

Six generic products of Arcoxia that received belated approval acquired generic exclusivity.

 

Other Arcoxia generics that were previously approved will go on sale next month.

 

On the 27th, the Ministry of Food and Drug Safety approved the generic etoricoxib products of 6 pharmaceutical companies - Theragen Etex, Guju Pham, Union Korea Pharm, Aju Pharm, Hana Pharm, Hutecs Korea Pharmaceutical.

 

The products also obtained generic marketing exclusivity, applicable from the day after (28th) to December 25th.

 

The 6 products will be produced by Theragen Etex under a consignment manufacturing agreement.

 

Generics of Arcoxia from Arlico Pharm, Boryung Pharmaceutical, Reyon Pharmaceutical, and Samil Pharmaceutical was first approved last month.

 

These companies also acquired generic exclusivity for their products until December 25th of this year.

 

During this period, drugs of the same substances are not allowed to be sold in the market.

 

Like the 4 products previously approved, the 6 products approved today also succeeded in avoiding Arcoxia’s patent by filing a defensive confirmation trial for the scope of right for Arcoxia’s crystalline patent.

 

Applications for approval were submitted on December 22nd, at the time of the original PMS expiry.

 

However, due to a delay in the review, the 6 products produced by Theragen Etex received approval a month later than the 4 products produced by Arlico Pharm.

 

Thus, the release of the 6 products is expected to be delayed by a month.

 

The 4 products produced by Arlico Pharm will be sold from the 1st of next month after completing the listing process.

 

Being generic exclusivity products, the listing process for the said products was completed a month faster than general generics.

 

According to UBIST, Arcoxia recorded outpatient prescription sales of 3.3 billion won last year.

 

Arcoxia is a competitor to ‘Celebrex,’ which dominates the nonsteroidal anti-inflammatory analgesic market.

 

As most of the pharmaceutical companies that will be releasing the Arcoxia generics also own their own generic versions of Celebrex, the industry expects the approval to create a synergistic effect of diversifying the prescription options in the analgesic market.

 

Accordingly, further attention is being paid to whether the introduction of these Arcoxia generics may impact the Celebrex-dominant market.