Generic for Forxiga competition in the 90 Billion market

Supreme Court rules to dismiss AZ appeal, nine months ahead of generic release

39 items from 14 companies will be released in April this year

The posting period ends in January next year

Forxiga

The patent for "Forxiga," a large diabetes treatment that produces more than 90 billion won a year, was completely lifted by the Supreme Court ruling.

 

It is expected that patent challengers will release Forxiga generic in two months.

 

Competition for generics is expected to intensify when the sales ban period ends in January next year due to the permission for priority sales items.

 

◆14 Generics are expected to be released in April this year, expanding to 90 in January next year On the 2nd, the Supreme Court ruled against 17 companies, including international drugs, in an appeal filed by AstraZeneca to side with generic companies.

 

As a result, patent challengers will be able to release generics after Forxiga's first substance patent expires on April 7 this year.

 

Patent challengers were qualified to release generics because they won the first and second trials.

 

However, AstraZeneca's appeal did not rule out the possibility of a reversal decision by the Supreme Court, putting a lot of pressure on the release of Generic.

 

The Supreme Court finally ruled in favor of patent challengers, and Generics succeeded in relieving the burden of patent infringement completely.

 

It is expected that 14 companies that have acquired generic for exclusivity will release the product in April.

 

Forxiga received generic for exclusivity use as 39 items of single and composite products.

 

Generic for Exclusivity is until January 7 next year, when Forxiga's second substance patent expires.

 

After that, more pharmaceutical companies are expected to enter the market.

 

According to the Ministry of Food and Drug Safety, 89 pharmaceutical companies have been approved for 285 items as a single Forxiga drug and complex.

 

This means that when the effect of generic for exclusive expires in January next year, more than 90 pharmaceutical companies will compete with the same ingredient.

 

◆Forxiga·Xigduo Last year's prescription amount of 91.4 billion won Drug price cuts are inevitable when General Electric is released.

 

The reason why generics are paying keen attention to the market is that Forxiga is producing more than 90 billion won in prescriptions.

 

According to UBIST, a pharmaceutical market research firm, Forxiga's outpatient prescription performance last year was 48.5 billion won.

 

It increased by 14% from 42.6 billion won in 2021.

 

Xigduo, a compound of dapaglyfluazine and metformin, recorded 42.9 billion won last year.

 

It increased 16 percent from 36.9 billion won a year ago.

 

Forxiga and Xigduo repeated rapid growth every year.

 

The combined prescription amount, which was 33.3 billion won in 2017, increased 2.7 times to 91.4 billion won in five years.

 

▲ Forxiga and Xigduo prescription performance by year (unit: 100 million won, data UBIST) However, it is widely expected that the existing growth will be dampened if the generic is released after April this year.

 

This is because a 30% reduction in drug prices is applied to the release of drugs with the same ingredient.

 

Then, one year after the release of the Generic, the drug price will be further lowered to 53.55% of the existing upper limit.

 

On top of that, AstraZeneca cannot avoid competition with Generic, which is newly entering the market.

 

Dong-A ST released Dapflo in December last year with the same ingredients as Poshiga.

 

Dapflo is a prodrug product with the same main ingredients but a different chemical structure from the original.

 

When absorbed into the body, the structure changes and has the same effect as Forxiga.

 

Dong-A ST alone challenged Forxiga's first substance patent for early release of generic.

 

After succeeding in avoiding the first trial, Dong-A ST pushed ahead with the sale of Dapflo based on the victory of the first trial at a time when a patent dispute with AstraZeneca was underway.

 

As a result, it released generic products about four months ahead of other companies that have acquired generic exclusivity.

 

Dong-A ST believes that it will take risks and preoccupy the generic market, given that Forxiga generic competition is expected to be very fierce in the future.

 

The key is how much Dong-A ST maximizes the effect of preoccupying the market for four months.

 

Dong-A ST has its own developed Suganon as a DPP-4 inhibitor-based diabetes treatment.

 

Dong-A ST plans to increase Dapflo's influence by linking with Suganon for the remaining two months until April when Forxiga generic is released.

 

In this extension, Dong-A ST plans to maintain the sale of Dapflo regardless of the Supreme Court ruling.

 

On the 2nd, the Supreme Court ruled in favor of AstraZeneca in an appeal filed by Dong-A ST against AstraZeneca on the avoidance of Forxiga's first substance patent.

 

In response, an official from Dong-A ST said, "The first trial, which was the basis for the release of Tapflo, has nothing to do with the Supreme Court's ruling, and the second trial is currently underway due to AstraZeneca's appeal."