Korean drug industry prepares for Peramiflu generic

3 out of 10 patent challengers applied for approval, possibly launching in winter

First patent dispute likely to conclude within this year, generic company winning the case would release the drug

Peramiflu supplied by GC Pharma

South Korean pharmaceutical companies are speeding up the launch preparation for a flu drug Peramiflu (peramivir) generic.

 

After filing trials for invalidation of original patent late last year, ten pharmaceutical companies recently applied for the generic approval.

 

If Ministry of Food and Drug Safety (MFDS) approves the generic and the companies win the ongoing patent dispute, the Peramiflu generics would be accessible in the market from coming winter at earliest.

 

The pharmaceutical industry sources reported on Sept.

 

11 that three Korean pharmaceutical companies have applied for approval on their Peramiflu generics in the last two months.

 

Peramiflu is an influenza drug sold by GC Pharma in South Korea.

 

GC Pharma licensed the drug from the U.S.-based BioCryst and received the Korean health authority approval in 2010.

 

The drug has a valid substance patent that expires on Feb.

 

12, 2027.

 

Apparently, 10 Korean companies have challenged Peramiflu’s patent by filing a patent nullification case in December last year.

 

Ilyang Pharmaceutical, Penmix, JW Pharmaceutical, Kolon Pharma, Kolmar Korea, Kolmar Pharma, HK Inno N, Chong Kun Dang, and Hanmi Pharmaceutical are part of the case.

 

Sources confirm three companies among the patent challengers have applied for the item approval so far.

 

Apparently, all three companies have their own manufacturing facilities.

 

The applications were submitted to MFDS on July 22, 30, and Aug.

 

14, respectively.

 

As a result, the three companies have met two out of three prerequisite conditions (first to file patent trial and first to apply for approval) to win the preferential sales rights.

 

Only one condition is left for them to achieve—they would need to win the patent trial.

 

The patent trial proceeding has reportedly picked up its speed again after being delayed by COVID-19 for a while in the first half of the year.

 

The industry expects the trial decision to be made by the end of the year at earliest.

 

The industry insiders also predict the generic could be released in winter, if the companies win the patent trial.

 

An official from a pharmaceutical company challenging the Peramiflu patent noted, "Currently, the patent dispute is actively progressing on paper.

 

We are expecting the Intellectual Property Trial and Appeal Board to conclude the trial within this year," and “meanwhile, the company is proceeding with patent dispute and item approval to launch the generic in coming winter.” Peramiflu is an improved formulation of oseltamivir, a substance of the top selling influenza treatment Tamiflu.

 

When Tamiflu has to be administered orally for five days, Peramiflu can be effective with only a single intravenous injection for 15 to 30 minutes.

 

Boosted by its convenience, Peramiflu is rapidly growing in the flu treatment market.

 

According to pharmaceutical market research firm IQVIA, Peramiflu has made 7.1 billion won last year.

 

Compared to 2 billion won generated in 2017, the sales almost tripled in three years.

 

In last two years, sometimes the supply was unable to keep up with demand and some regions experienced shortage.