Generic for Dukarb is coming soon

↑ Interested in the judgment of the second trial of the patent dispute

Announcement of benefit at the end of this month after approval in December last year

Generic is expected to be released next month

According to the second trial decision of Dukarb on the 16th of this month, it is decided whether to release the core capacity at the same time.

 

With Boryung Kanarb's generic set to be released next month, attention is focused on the second trial of the patent dispute, which is three days away.

 

This is because the decision of the patent court determines whether to release the Dukarb generic core capacity at the same time.

 

◆Dukarb's generic will be released sequentially after registering next month's benefit According to the pharmaceutical industry on the 13th, the material patent of Boryung Kanarb expired as of the 1st of this month.

 

In principle, a generic for Kanarb has become available.

 

In addition, the remaining generics, except for the core capacity of Dukarb, which is protected by patents for composite compositions, will also be available.

 

The drug that generics are paying attention to is Dukarb.

 

Currently, 27 pharmaceutical companies have been licensed for 72 items of Dukarb generics with different capacities.

 

No single-system Kanarb Generic has been licensed.

 

They received permission for related products from December to January this year.

 

He then applied for a salary registration with the HIRA.

 

According to related regulations, Health insurance benefits will be announced two months after the date of application and will be applied as of the 1st of the following month.

 

Since generic companies applied for salaries in December last year, it will be announced at the end of this month and the salaries will be applied from the 1st of next month.

 

As a result, Dukarb generic is expected to be released sequentially after next month.

 

Products from the four companies approved in December last year are expected to be released first on the 1st of next month, followed by products from the remaining 23 pharmaceutical companies on April 1.

 

The pharmaceutical industry's attention is focused on the second trial of the Dukarb patent dispute, which is just three days away.

 

This is because the ruling determines whether Dukarb's core capacity will be released simultaneously.

 

Dukarb is protected by a patent that expires in 2031.

 

However, the scope of this patent is limited to Dukarb 30/5 mg.

 

Except for this capacity, the rest can be released after the 1st of next month regardless of the 2nd trial ruling.

 

The key is the 30/5 mg product.

 

If the patent court sides with Generic on the 16th of this month, Generic can release 27 items of Fimasartan and S-Amlodipine 30/2.5mg products simultaneously as other generics.

 

In the case of S-Amlodipine, it is interpreted as half the dose of Amlodipine.

 

The combination of Fimasartan and S-Amlodipine 30/2.5mg chosen by generics means that it is virtually the same drug as the original drug Dukarb's 30/5mg.

 

If the court sides with Boryung in the second trial following the first trial, the timing of the release of the 30/2.5mg product by generics will be postponed.

 

The product can be released only when generic companies win a reversal decision from the Supreme Court through an appeal or win a separate invalidation trial.

 

If both methods fail, the capacity product may not be released until 2031, when the Dukarb patent expires.

 

According to UBIST, a pharmaceutical market research firm, Dukarb's prescription last year was 46 billion won.

 

Boryung explains that more than half of the performance comes from 30/5mg products, which are core doses.