Full-fledged competition in the ultra-large market

such as Dukarb and Forxiga from April

90 generics for Forxiga Xigduo entered the pile after the end of the patents

Competition among domestic pharmaceutical companies surrounding the ultra-large market is expected to intensify from April.

 

About 20 companies are expected to receive benefits in the late-breaking drug market for Dukarb, a high blood pressure complex drug of Boryung, which four companies first entered in March, and AstraZeneca's diabetes drug Forxiga's generics have been poured in in droves since April 7, when the patent expired.

 

because it is highly probable.

 

Last year's outpatient prescriptions were 46 billion won for Dukarb, 48.5 billion won for Forxiga, and 42.9 billion won for Xigduo XR, a combination of Forxiga and Metformina.

 

According to the industry on the 1st, domestic pharmaceutical companies are warming up ahead of entering the large market in April.

 

First, a large number of products licensed in January are expected to be listed in Dukarb's generic market.

 

In March, four companies (Arlico, Hana, Hutecs, and Shin Poong), which were licensed in December, entered the market first.

 

However, most companies were approved in January.

 

Only 23 companies were licensed in January.

 

Unlike the original amlodipine, they used S-amlodipine.

 

Since the patent for Kanarb's active ingredient Fimasartan expired on February 1st, there are no barriers to market entry.

 

However, there is no approved item for Kanarb's generic, which is a single agent.

 

Regarding this, an official from a generic company explained, "I understand that they prefer Dukarb's generic, a combination drug, rather than Kanarb, considering the low price of a single drug and its status as a domestic new drug." Given that many generic companies are small and medium-sized enterprises, it is interpreted that they are establishing market strategies considering costs.

 

Forxiga and Xigduo, which use Dapagliflozin as an active ingredient, the entry barrier has been virtually removed after the first substance patent expired on April 7 as the Supreme Court ruled that the second substance patent was invalid in early February.

 

Regardless of the size of sales, most domestic pharmaceutical companies are expected to jump into the generic market.

 

Only 89 companies have licensed Forxiga and Xigduo generics.

 

However, among these, if the deadline for applying for reimbursement was missed in January, if the same ingredient as the applied combination drug is not on the reimbursement list, or if the drug is the same as generic for exclusivity, it will be difficult to enter the market on April 8.

 

In most cases, registration is expected on May 1st, and in the case of the same drug as the generic for exclusivity item, market entry is only possible after January 7th next year when the validity of the generic for exclusivity expires.

 

It seems that many items other than these products will be paid for at once on April 8th.

 

It is known that a number of companies applied for reimbursement in January, and the HIRA conducted a drug price calculation last month.

 

There is also a concern that the market will become complicated, such as illegal rebate competition, if generics are rushed at once.