[뉴스웨이 이병현 기자]
Fierce competition is expected as generic drugs (generic drugs) of Sama Pharmaceutical’s asthma and rhinitis treatment ‘Citus (ingredient name: franlukast)’ have been approved one after another.
According to the Ministry of Food and Drug Safety (hereinafter referred to as the Ministry of Food and Drug Safety) on the 8th, five generic Citus products received approval. Dasan Pharmaceutical’s ‘Pritus Tablet 50mg’ proved bioequivalence and became the first generic on the 5th, and Dongkook Pharmaceutical (Pranpid Tablet), GC Green Cross (Neopran Tablet), and Daewoong Bio (C2Exploration) also released the product the very next day, on the 6th. Additional product approval was obtained. Next, Hanwha Pharmaceutical’s ‘Hanwha Franlukast Tablet 50 mg’ was approved on the 7th. They are expected to obtain priority sales product approval (priority distribution rights) as first generics.
Previously, seven companies, including Dasan Pharmaceutical, Dongkuk Pharmaceutical, Green Cross, Daewoong Bio, Hanwha Pharmaceutical, Donggu Bio Pharmaceutical, and Aprogen, requested an evasion judgment on Sama Pharmaceutical’s Citus Tablet formulation patent in January this year. Among them, five companies, excluding Aprogen and Donggu Biopharmaceuticals, which voluntarily withdrew their lawsuit last June, succeeded in receiving product approval this month.
Pranlukast is a drug used to treat asthma and allergic rhinitis. It works by reducing airway constriction and mucosal swelling. The original drug is Dong-A ST’s ‘Onon Capsule’, and Citus Tablet is an improved new drug with improved bioavailability. Sam-A Pharmaceutical received approval in 2016 for changing the formulation from capsules to tablets so that the same effect can be achieved by reducing the original product’s 225 mg of ingredients to 50 mg.
The market for pranlukast ingredients was reported to be worth 51.2 billion won last year, up 30.2% from the previous year based on UBIST. The Citus family, including various preparations, is worth 42.6 billion won, or 83% of the total market. In addition, the original Onon Capsule is worth 3.7 billion won, SK Chemicals’ ‘Pranair Capsule’ is worth 2.3 billion won, and Yuhan Corporation’s ‘Plakanon Tablet’ is worth 2.7 billion won.
Citus, which accounts for most of the market, recorded cumulative prescription performance of 33.6 billion won in the third quarter of this year and is expected to record close to 50 billion won by the end of the year.
Citus is the flagship product responsible for Sam-A Pharmaceutical’s sales, and about half of the 97.2 billion won in sales last year came from Citus family products such as Citus tablets, Citus dry syrup, and Citus suspension tablets. In August of this year, Sama Pharmaceutical received approval for its new product, ‘Citus Chew Tablet,’ which has improved the convenience of taking for pediatric patients in a chewable form with the launch of generics in mind.
All generic companies that have successfully evaded patents this time can only release existing tablets, so it is interpreted that they are embarking on a defense strategy by expanding their product line.
Typically, the process of applying for and listing generic products for insurance benefits takes three months. If you apply for insurance benefits immediately after approval, it is expected that generic products will be released one after another starting in February of next year.
The generic product is expected to adopt a strategy to penetrate the pranlukast ingredient market, which has annual sales of 50 billion won, through low drug prices after its launch.
However, the performance of Citus generics cannot be guaranteed. In fact, in the market for montelukast, a drug with the same mechanism, the original product, ‘Monterizine’ from Hanmi Pharmaceuticals, succeeded in defending its market share for nearly a year.
Hanmi Pharmaceutical’s asthma and allergic rhinitis treatment Monterizine is an improved new drug that combines the original product, MSD’s Singulair (ingredient name montelukast), with the antihistamine ingredient ‘levocetirizine’. Monterizine is a competitive drug targeting the same indication market as Citus. Monterizine’s main ingredient, montelukast, and Citus’s main ingredient, pranlukast, are members of the same leukotriene receptor antagonist class.
While montelukast preparations are taken once a day, pranlukast preparations have the disadvantage of having to be taken twice a day, so the prescription preference for montelukast drugs is higher.
According to UBIST, after the launch of 19 Monterizine generics in October last year, the market share of late-release drugs this year was only around 20%. Until July 1st, when First Generic’s right-of-way distribution expired, companies carried out fierce sales promotions, but in the first half of the year, Monterizine successfully defended its market share, accounting for 87.07% of sales for capsule preparations and chewed tablets combined. On the other hand, Hanwha Pharmaceutical’s ‘Singulien Plus’, which accounted for the largest share of generics, accounted for 6.92%, while other generics showed poor performance with a share of less than 5%.
The market for montelukast and levocetirizine combination drugs is expected to have recorded total sales of KRW 11.25 billion in the first half of this year since the launch of generics, and if the trend continues into the second half of the year, it is expected to grow by about 50% compared to last year’s annual sales of Monterizine of KRW 15.5 billion. Of these, Monterey sedation sales accounted for the majority, at approximately 8.7 billion won.
This is interpreted as the fact that despite the generic offensive, the overall market grew and the benefits were concentrated on original products that expanded their existing sales network.
In particular, considering that there is generally a high preference for the original in the domestic market, it may be difficult for the Citus generic to do well in the market as it does not have a competitive advantage, such as ease of use, compared to the original. Singulien Plus, which recorded the highest sales among generics in the Monterizine generic market, has the advantage of improving patient compliance and medication convenience through its smaller tablet formulation than competing products.
Reporter Byeong-Hyeon Lee bottlee@
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