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Xarelto sales fall 30% due to generics and price cuts
by Oct 26, 2022 05:50am
The quarterly prescription of new oral anticoagulants (NOAC) containing rivaroxaban, which had reached KRW 15 billion, has shrunk to KRW 13 billion. This decrease is interpreted to be reflected by the price cut of Bayer’s original ‘Xarelto.’ Its generics that entered the market 1 year ago have been starting to slowly increase their share in the market, making KRW 2.4 billion in total. ◆Xarelto takes a direct blow from drug price cuts...Quarterly sales record KRW 11.3 billion According to the market research institution UBIST on the 25th, the domestic outpatient prescriptions of rivaroxaban recorded KRW 13.7 billion in Q3 this year, falling fell 16% compared to the KRW 16.4 billion it recorded in the same period last year. Sales of the original, Xarelto, fell 29% from KRW 15.9 billion to KRW 11.3 billion. Quarterly outpatient prescriptions of Xarelto fell from KRW 15.9 billion in Q3 last year, to KRW 15 billion in Q4, then to KRW 14.2 billion this year, to KRW 13.9 billion in Q1, then sunk to KRW 11.3 billion in Q3. This reduced sale is analyzed to have been greatly influenced by the drug price cut that had been made in August. The Seoul High Court ruled in favor of the Ministry of Health and Welfare in the lawsuit Bayer filed against MOHW to cancel the disposition on lowering Xarelto’s price. With the ruling, the drug price of all strengths(2.5·10·15·20mg) of Xarelto was reduced by 30% from August 22nd. Xarelto’s price had first been set to be reduced in May last year when the generics were first listed for reimbursement, but Bayer filed a suit on the unjustness of the price cut, claiming that the generics were released before Xarelto’s patent expiry, thus the execution of disposition should be suspended. As a result, the price cut had been suspended until the judgment on the merits. After about a year and two months, the final ruling had been made and the drug price was reduced. Considering the 30% price cut, there was no significant change in prescription volume compared to the same period last year. With this, the prescription amount of Xarelto is expected to be in the lower KRW 50 billion range. Its annual prescriptions last year were nearly KRW 60 billion. ◆Generics account for 18%...Sole lead held by Chong Kun Dang Xarelto’s generics have been increasing their influence in the market. In Q3, Xarelto generics made KRW 2.4 billion in total. In Q2 last year, the amount was KRW 0.3 billion, which rose to KRW 0.5 billion in Q3, to KRW 0.9 billion in Q4, then to the KRW 2 billion range this year. In Q1 2022, prescriptions rose to KRW 1.6 billion in Q1 and then KRW 2.1 billion in Q2. In Q3, generics have also been increasing steadily, accounting for an 18% share of the rivaroxaban market. With the sales of the generic increasing slightly and the original dropping significantly, the share of generics in the market rose 5%p from the previous quarter. Even though there was no change in the prescription amount of the original drug, the prescription amount of generics increased with the generic companies’ pioneering of new markets. Generic companies focused their marketing capabilities on local clinics as the original drug is mostly prescribed in hospitals or higher institutions. Instead of competing directly with the original, the companies focused on pioneering new markets. Although more than 60 companies have received approval for Xarelto generics, only Chong Kun Dang and Hanmi Pharmaceutical have made meaningful sales. Chong Kun Dang’s ‘Riroxia’ made KRW 0.8 billion in outpatient prescriptions in Q3, and accounted for 1/3 of the generic market. Chong Kun Dang released Riroxia in May last year, 5 months before patent expiry, and worked to preoccupy the market. Although other generic companies started to enter in October of the same year, unlike Chong Kun Dang which continuously made prescriptions after preoccupying the market, sales of the other generics remain in the KRW 0.1 billion range. Among generics, Hanmi Pharmaceutical’s ‘Riroxvan’ made KRW 0.5 billion in Q3 and is the only generic chasing Chong Kun Dang’s Riroxia’s sales in the market. Hanmi Pharmaceutical succeeded in avoiding Xarelto’s patent with SK Chemical and entered the market with generic exclusivity. Riroxvan, which sold KRW 0.2 billion in Q1, rose to KRW 0.4 billion in Q2, then KRW 0.5 billion in Q3. More than half of the approved generics have not yet released their versions in the market. With the lower dose of Xarelto (2.5mg) being listed for reimbursement from Q3, how this will affect the market is also gaining attention. 16 low-dose versions of Xarelto generics were listed for reimbursement in July. Rivaroxaban 2.5mg is mainly used in combination with aspirin to reduce the risk of cardiovascular events in patients with coronary artery disease and peripheral arterial disease.