Will Hanmi and Chong Kun Dang's generic exclusivity effect?

Only two pharmaceutical companies have generic exclusivity for Mirabegron

328 generics have won generic exclusivity

It is noteworthy whether Hanmi Pharm or Chong Kun Dang among the domestic pharmaceutical companies will be able to achieve the performance in the market while acquiring generic exclusivity, which is the most outstanding pharmaceutical company.

 

In particular, attention has been focused on Hanmi and Chong Kun Dang in that there are no successful cases among the products that have obtained a generic drug exclusivity introduced in 2012.

 

Mirabeg SR 50mg Chongkundang Mirabegron SR Tab 50mg On the 1st, the Ministry of Food and Drug Safety designated Hanmi Pharm's 'Mirabeg SR 50mg' and Chong Kun Dang's 'Chongkundang Mirabegron SR Tab 50mg' as generic drug exclusivity.

 

Accordingly, the two products obtained the right to monopolize in the generic market for 9 months from May 4 to February 3 of next year, when the material patent of the original product expires.

 

This is because generic drugs cannot be put on the market during this period.

 

In addition to the two drugs, it was found that there were no products to receive additional generic exclusivity.

 

The Ministry of Food and Drug Safety explained that there are only two products that have obtained a right to generic exclusivity in the Mirabegron, which is used as an overactive bladder treatment.

 

Of course, there were many other pharmaceutical companies that participated in product development and patent litigation aimed at generic exclusivity in addition to Hanmi and Chong Kun Dang.

 

However, it was reported that most of the bioequivalence tests did not prove the equivalence with the original.

 

An official from the related company said that the original product, Betmiga, is a sustained-release preparation in which the drug is slowly released from the body, so that the generic drugs with the same ingredients were found to have difficulty in equivalence.

 

In addition, he said that there are no pharmaceutical companies applying for permission immediately after PMS ends, except Hanmi and Chong Kun Dang.

 

Betmiga's PMS expired on December 30 of last year, and only Hanmi and Chong Kun Dang appear to have submitted the ANDA(Abbreviated New Drug Application) on December 31, the next day.

 

This is the explanation that the first patent challenge, the patent lawsuit win, and the conditions for the first license application are satisfied, and the products of Hanmi and Chong Kun Dang have obtained generic exclusivity.

 

Eleven companies, including Hanmi and Chong Kun Dang, participated in the patent challenge, and the nine companies did not appear to meet the requirements for the initial permit application.

 

As a result, Hanmi and Chong Kun Dang, which are known to have the largest number of salespeople in Korea, gained exclusive rights to the generic market of Betmiga.

 

Hanmi has approximately 1000 salespeople and Chong Kun Dang has approximately 900 salespeople, and both companies have a number of hospitals clients in Korea.

 

Accordingly, it is expected that the market share can be increased as much as possible during the period of monopoly.

 

Betmiga's outpatient prescription last year was ₩54.7 billion.

 

Even if they take 20% of the share of the two pharmaceutical companies, they will be able to exceed the ₩10 billion market.

 

Because Astellas' influence is so great, there are many prospects that even Hanmi and Chong Kun Dang will not be easily taken away.

 

This was also seen in the case of Vesicare (Solifenacin), an irritable bladder treatment in 2017.

 

Ahn-gook Pharm and Hanmi Pharm, which have salt-changing products, succeeded in avoiding patent expiration and came out 7 months and 3 months before generics, respectively, but were insufficient to threaten the original.

 

Looking at the outpatient prescription amount (Source: UBIST) last year, Ahngook's A-Care was promoted to ₩3 billion and Hanmi’s Besigum amounted to ₩2.1 billion, but it was less than Vesicare’s ₩13.4 billion.

 

Nonetheless, the two pharmaceutical companies are expecting 9 months of monopoly.

 

An official of the related company said that although there is a patent appeal with the original company, it is expected to enforce the launch because it has obtained generic exclusivity and it is expected to monopolize the market once there is no representative generic drug itself.

 

Meanwhile, so far, 328 generics have won generic exclusivity.

 

However, no case has ever grown into a large-sized product that exceeds ₩10 billion annually.

 

This is analyzed because there are many products from the same ingredient, and because of illegal marketing regulation, it is not able to exert the sales power of generic drugs as before.