Generic exclusivity for ₩50 million Betmiga applied

Upcoming June launches, successful patent challenge of 11 companies

First applicant has generic exclusivity, some commercialization failed?

The first generic drug of 'Betmiga' (Mirabegron, Astellas), a potent overactive bladder treatment, coming soon in June this year applied for permission.

 

The interest in the industry is amplified because generic exclusivity are given exclusive rights to the generic market based on who first applied for the permit.

 

According to the MFDS and the industry on the 10th, the application for permission of the Betmiga was received on Dec 31.

 

Since the re-examination period for the Betmiga was expired on Dec 30, the application for authorization was submitted the next day, Dec 31.

 

However, the number of licensed items and company names have not been disclosed yet.

 

Currently, 11 Korean companies have established the basis for early entry into the market, excluding the material patents of Betmiga, winning the decision to invalidate crystalline invalid patents.

 

Accordingly, the first applicant of the 11 companies is likely to obtain a generic exclusivity, which is granted generic market monopoly for nine months.

 

The 11 companies are Hanmi pharmaceutical, Chong Kun Dang, JW pharmaceutical corporation, Daewoong Pharmaceutical, Ildong Pharmaceutical, Intro biopharma, Alvogen Korea, Kyungdong pharmacetical, Shinil Pharm Ltd, Hanwha Pharma Co., LTD, and Shin Poong Pharm.

 

Co., LTD.

 

However, all 11 companies did not submit the application for permission last month.

 

Some companies have reportedly failed to demonstrate bioequivalence with the original drug.

 

As such, only a few companies are likely to win generic exclusivity.

 

Generic exclusivity is expected to be granted for nine months from the day after May 3, 2020, when the Betmiga’s patent expires.

 

During this period, the same ingredient generics will not be released, so it is highly likely that the rights holder will preoccupy the market.

 

Accordingly, companies that have acquired generic exclusivity are expected to conduct aggressive marketing and marketing during that period.

 

Betmiga is a large item of about ₩50 billion per year.

 

In 2020, it is expected that Betmiga’s generics will struggle over the market.