Generics for Arcoxia are coming soon

Products from 10 domestic companies, patent avoidance, and new drug PMS are also ending

Generic for Arcoxia, COX-2 anti-inflammatory analgesic is expected to be released soon.

 

As the PMS ended on the 22nd of last month, it was confirmed that the generic company received the application on the 23rd, the next day.

 

Since generic companies have already confirmed patent avoidance, they are expected to market their products as soon as they go through approval and reimbursed procedures.

 

According to the MFDS on the 3rd, generic companies for Arcoxia (Etoricoxib) received applications on the 23rd.

 

This drug is used to relieve symptoms or signs of osteoarthritis (degenerative arthritis).

 

MSD Korea's Arcoxia obtained a domestic approval on December 23, 2014.

 

The MFDS ordered a re-examination (PMS) for 6 years, and the end of the re-examination was on the 22nd of last month.

 

Generic companies have been preparing for the market step by step.

 

It succeeded in evading the patent with the remaining term.

 

A trial was filed to confirm the scope of passive rights to evade crystalline patent of Arcoxia, and the claim was finalized in May last year.

 

Participating pharmaceutical companies were Theragen Etex, Hana Pharm, Union Korea, Aju, Arlico, Reyon, Daewoopharm, Boryung Pharmaceutical, Hutecs, and Guju.

 

A bioequivalence test was also conducted for product approval.

 

Three companies of Theragen Etex, Aju, and Arlico conducted a bioequivalence test using Arcoxia as a reference drug.

 

Accordingly, it seems that it succeeded in demonstrating the equivalent of the original drug and applied for permission immediately after the end of PMS.

 

Arcoxia(Etoricoxib) is a nonsteroidal anti-inflammatory analgesic (NSAID) family of selective COX-2 inhibitors.

 

In particular, it attracted attention that it is a follow-up item made by MSD of Vioxx (Rofecoxib), which was removed from the market due to cardiovascular risk as a COX-2 inhibitor.

 

Arcoxia directly conducted clinical trials in Korea to resolve the safety controversy.

 

However, there were fewer recognized indications than the competitive product Celebrex (Celecoxib).

 

Arcoxia is only approved for osteoarthritis, whereas Celebrex has five indications, including ankylosing spondylitis, rheumatoid arthritis, and primary menstrual pain, as well as osteoarthritis.

 

This leads to differences in performance in the market.

 

Looking at the amount of outpatient prescriptions based on UBIST in the first half of last year, sales of Celebrex was ₩20.1 billion, whereas sales of Arcoxia were ₩1.7 billion.

 

Large pharmaceutical companies except for Boryung analyzed that generics for Arcoxia were not very attractive in that they had limited indications for Arcoxia and generics for Celebrex were released after 2015.

 

However, it is expected that the generics applied for approval this time will be able to produce new product effectiveness as they are the first generics that have successfully evaded patents.