Competition for Pelubi's generics worth ₩30 billion

Daewon Pharmaceutical differentiates by adding original formulation change, salt change + indications

Pelubi's follow-up decision and↑ Pelubi's interest in the new patent challenge

Pelubi

It is expected that generic competition will take place in earnest in the Pelubi market, a osteoarthritis treatment worth 30 billion won per year.

 

Following Youngjin Pharmaceutical, which launched generic alone, Huons and Chong Kun Dang are predicting their entry into the market.

 

Daewon Pharmaceutical, which faces the challenge of generic, is in a situation where it is confronting each other by releasing follow-up drugs such as original formulation change and salt change products.

 

◆Generic for exclusivity of first generics ends According to the pharmaceutical industry on the 6th, the period of Youngjin's Pelubi will end on the 25th of this month.

 

Phelps is the first generic of Daewon Pharmaceutical.

 

Youngjin Pharmaceutical received generic for exclusivity.

 

Accordingly, except for Youngjin Pharmaceutical, the other generic companies were not able to release the same-active ingredients within the generic for exclusivity period.

 

Huons and Chong Kun Dang are expected to release Generics in earnest when Phelps' priority sales period expires on the 25th of this month.

 

Like Youngjin Pharmaceutical, the two companies have surpassed patent of Pelubi.

 

In April and May last year, generics for Pelubi received product approval, respectively.

 

Huons has already received insurance benefits.

 

When generic for exclusivity expires, generic can be released immediately within this month.

 

Daewon Pharmaceutical, the original company, is developing strategies such as developing follow-up drugs and adding indications.

 

Daewon Pharmaceutical plans to release Pelubi S, which was approved as a salt-changing product last year, soon.

 

Daewon Pharmaceutical explained that it improved drug solubility and side effects of GI disorders through salt changes.

 

In the case of Pelubi SR, which was released earlier, it already has more performance than Pelubi.

 

According to UBIST, a pharmaceutical market research firm, Pelubi and Pelubi SR's outpatient prescriptions amounted to 32.5 billion won last year.

 

Among them, Pelubi SR's prescription performance is said to account for about 70% of the total.

 

It is analyzed that the addition of indications had a significant impact on the expansion of Pelubi SR's prescription performance.

 

Daewon Pharmaceutical added "post-traumatic pain" as an indication of Pelubi SR in May 2020.

 

It is an indication that Pelubi does not have.

 

◆ Unfinished patent dispute, Pelubi SR's New Patent Challenge Variables There are two main variables of generic competition in Pelubiprofen market in the future.

 

One is the Pelubi patent dispute.

 

Youngjin Pharmaceutical, Huons, and Chong Kun Dang won in the first trial, but Daewon Pharmaceutical objected to the decision.

 

If Daewon Pharmaceutical wins, sales of Pelubi generic will be discontinued.

 

Generics companies are also forced to compensate for damages caused by patent infringement is inevitable.

 

There is a possibility that Daewon Pharmaceutical's delayed drug price reduction may be executed according to the subsequent ruling.

 

Daewon Pharmaceutical filed a lawsuit with the Seoul Administrative Court to cancel the drug price reduction, dragging the patent dispute against Pelubi to the second trial.

 

If Daewon Pharmaceutical loses in the second trial, the drug price of Pelubi will be reduced by 30%.

 

Another variable is the new patent challenge for Pelubi SR.

 

With Pelubi SR performing more than Pelubi, Huons, Chong Kun Dang, and Mothers are reportedly preparing to challenge composition patent of Pelubi SR .

 

Mothers Pharmaceutical has already begun BA test of generics for Pelubi SR.

 

Mothers Pharmaceutical was approved by the MFDS in July 2020 for a clinical trial for BA evaluation of Pelubi SR and Pelum SR.