(Health Korea News / Lee Chung-man) Sama Pharmaceutical’s flagship asthma treatment ‘Citus Tablet’ (ingredient name: pranlukast) has entered the era of full-fledged generics.
On the 5th, Dasan Pharmaceutical received approval for ‘Pritus Tablet’ (ingredient name: Franlukast Hydrate) 50mg as a prescription drug from the Ministry of Food and Drug Safety. The target indications are treatment of bronchial asthma and allergic rhinitis.
‘Cytus Tablet’, the original of ‘Pritus Tablet’, is a pranlukast preparation that selectively antagonizes the type 1 cysteine leukotriene receptor (CysLTR1) and inhibits its activity.
Leukotrienes regulate the immune response by inducing the influx of inflammatory cells into the airway walls and increasing mucus secretion. If expressed excessively, it causes allergic diseases such as asthma and rhinitis.
A drug in a similar class is montelukast. Representative examples include MSD’s ‘Singulair’ (ingredient name: montelukast) and Hanmi Pharmaceutical’s combination drug ‘Montelizine’ (ingredient name: montelukast sodium + levocetirizine hydrochloride), which adds the antihistamine levocetirizine to montelukast.
The difference is that montelukast preparations are taken once a day, and pranlukast preparations are taken twice a day. As a result, the respective market sizes were KRW 88.3 billion and KRW 26 billion as of UBIST in 2022.
This is why the industry’s preference for montelukast preparations is much higher than that for pranlukast preparations. As of the 5th, as of the Ministry of Food and Drug Safety approval, there are 260 montelukast preparations, but only 13 pranlukast preparations.
However, as competition in the montelukast preparation market becomes increasingly saturated, some companies appear to be attempting to enter the pranlukast preparation market.
In addition to ‘Citus Tablet’, Franlukast preparations include ▲Dong-A ST’s ‘Onon Capsule’ ▲SK Chemicals’ ‘Pranair Capsule’ ▲Korea Prime Pharmaceutical’s ‘Franca Capsule’ △Yuhan Corporation’s ‘Pranukanon Tablet’.
However, ▲’Onon Capsule’ ▲’Planair Capsule’ ▲’Franca Capsule’ are capsule formulations and have the disadvantage of being difficult to swallow due to their larger size compared to tablets. △’Fracanon Tablet’ is a tablet, but it is manufactured in a rectangular shape with sharper edges compared to the oval-shaped ‘Citus Tablet’, making it somewhat inconvenient to take.
This is the background for generic companies to develop generics specifically targeting Sama Pharmaceutical’s ‘Citus Tablet’ among various pranlukast preparations.
However, in order for generic companies to develop pranlukast preparations, they must overcome the patent barrier. The substance patent for pranlukast has already expired, but each company holds different manufacturing patents.
Sama Pharmaceutical’s ‘Citus Tablet’ holds a manufacturing patent that expires in June 2035.
It is natural for generic companies to seek to invalidate the manufacturing patent for ‘Citus Tablet’, which has more than 10 years remaining. Starting with Dasan Pharmaceutical on January 12 of this year, a total of seven companies, including Dongkook Pharmaceutical, Hanwha Pharmaceutical, GC Green Cross, Daewoong Bio, A Project Biologics, and Donggu Biopharmaceuticals, passively confirmed the scope of rights for the ‘Citus Tablet’ patent with the Intellectual Property Trial and Appeal Board. Judgment was filed.
In response to this, the Intellectual Property Trial and Appeal Board ruled in October of this year to cite a patent invalidation lawsuit filed by four companies, including Dasan Pharmaceutical, GC Green Cross, Daewoong Bio, and Dongkook Pharmaceutical, and the patent lock on ‘Citus Tablet’ was lifted.
Therefore, Dasan Pharmaceutical’s ‘Pritus Tablet’ is expected to compete in the market in earnest with ‘Citus Tablet’ as the first generic version of ‘Citus Tablet’ to obtain approval from the Ministry of Food and Drug Safety.
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