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- 2026-05-20 12:30:53
- Opinion
- [Reporter’s eye] Measures about NDMA should be careful
- by Lee, Tak-Sun Apr 16, 2020 06:34am
- Measures are imminent when the MFDS begins testing by collecting finished products of Metformin, which are used as diabetes treatments. In last December, an excess of NDMA (N-nitrosodimethylamine), a carcinogen, was detected in Metformin preparations in Singapore. Since then, the MFDS has been conducting extensive investigations. After collecting and inspecting about 900 raw materials, it is believed that the investigation process is being expanded to the finished product and the process of selecting products with excess impurities is in progress. Although the results of the investigation are still unknown, some people have analyzed that NDMA was detected in the raw material and then expanded the investigation to finished products using the raw material. The MFDS only states that it is currently considering various aspects of the investigation direction and measures. Regardless of the results of the investigation, measures against Metformin preparations should be determined more carefully than existing NDMA-detected products. This is because Metformin is used as a primary treatment for type II diabetes treatments. Diabetes patients who are being treated for the first time are starting with Metformin. And. Metformin with other drugs, a combination of metformin and other ingredients is also on the market. There is also a survey that the size of the outpatient prescription market for drugs containing Metformin alone reaches ￦473.2 billion (Source: UBIST). Therefore, as in the case of Ranitidine, if Metformin is banned and recovered, there is no alternative drug, and the lack of alternative medications will create a great disruption for the market, medical staff and patients. Therefore, measures to minimize the impact should be prepared. The products of concern should be selected rather than a quick investigation. If there are medicines of concern for risk, the first priority is to protect the safety of the people through prompt action. The MFDS will have a lot of worries in many ways. There are conflicting results abroad. The U.S. FDA announced in mid-February that it did not recommend recovery because Metformin's NDMA issue was not serious, while some products are being recovered in Singapore and Canada. In the United States, a private research institute, Valisure, also suggested that FDA recover the product, saying that some Metformin products had excessive NDMA. It is best that NDMA does not exceed daily allowances in Metformin products, but if there are products detected in excess, measures should be taken to minimize the gaps in patient care.
- Company
- KRW 2 trillion worth damage by COVID-19 to hit drug industry
- by Nho, Byung Chul Apr 16, 2020 06:33am
- Impacted by COVID-19 outbreak, Korean pharmaceutical industry requested the government for an emergency initiative like new pharmaceutical regulatory policy to avoid a total dissolution of the Korean pharmaceutical and bio industry. The industry has requested the government to halt the new pharmaceutical regulatory policy but to reinforce the industry support policy. It claims massive sales loss among the industry is inevitable due to COVID-19, and threats like delay in R&D, unstable supply of active ingredient and surge in production cost are storming in simultaneously. Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA, President Won Hee-mok) announced on Apr. 13 the organization has delivered an official request to Ministry of Health and Welfare (MOHW) for favorable regulatory policy amid the state of emergency, as the pharmaceutical and bio industry need to serve its original purpose of ‘social safety net’ that protects the life and health of the people. The organization’s official statement projected the Korean pharmaceutical and bio industry would see loss estimated at 1.8 trillion won (at least 10 percent of the total pharmaceutical expense) due to maximum 46 percent drop in outpatient numbers. Moreover, the statement warned the revenue dip would unavoidably affect business operation in all sectors including R&D and facility investment and employment. The situation could worsen as a number of clinical trials have already been delayed or suspended with lack of participants and medical professionals preoccupied with the virus containment. As some drugs in development would have to start over their clinical trials, the industry extremely concerned of losing over 100 billions of wons in a long term. The pharmaceutical manufacturers are also to face increased cost of raw materials due to unstable supply of pharmaceutical substance in the global market and skyrocketed value of US dollars against Korean won. Moreover, many of Chinese active ingredient manufacturing facilities have been closed, and the Indian government has restricted export of 26 active pharmaceutical ingredients. When the cost of raw materials jump by 25 percent, the industry would see production cost surge by approximately 1.7 trillion won. With the industry challenged by various threats at once, the organization strongly urged the government to put a brake on the implementation of the new pharmaceutical regulatory policy for the industry to withstand the second and third waves of the pandemic impact. KPBMA has stressed the government has already enforced drug pricing reduction worth of 100 billion won in January based on surveyed actual transaction price, and it also plans to reduce drug pricing worth of 200 billion won by next January based on increased volume and limited period of weighted pricing, which would add up to about 320 billion won-worth of damage. Including additional pricing reduction worth of 650 billion won on already-listed drug by the differentiated generic pricing, the pharmaceutical industry would be hit by pricing reduction of approximately 1 trillion won, which is about five percent of total National Health Insurance claim. Also the pharmaceutical organization has expressed deep concern over the legislative notice issued on the revised healthcare reimbursement standard in last month, adding a clause ‘narrowing reimbursement scope or reducing drug pricing of reevaluated listed drugs.’ And if the clause comes in effect from July, the damage on the industry would be permanent. The organization official pleaded, “To overcome the global crisis, the implementation of the new pharmaceutical regulatory policy should be suspended, and post-management drug pricing reduction should be postponed for a year to allow minimum time for the industry to overcome the unpredictable crisis.” The official then particularly asked for regulatory boost like R&D support, tax benefit and expedited review for the development of COVID-19 treatment and vaccine and the establishment of drug substance and essential drug manufacturing facilities in Korea. KPBMA official highlighted, “Amid the COVID-19 pandemic, the pharmaceutical industry would focus all capacity into developing treatment and vaccine and providing essential drug,” and “Regardless of any hardships, the industry is committed to protect the people’s health and lives.” “Backed with emergency response and groundbreaking level of the government support, the Korean pharmaceutical and bio industry would be able to conquer the crisis and become the state’s new economic driving force and reliable social safety net,” and “the industry would leverage the Korean economic advancement and pharmaceutical manufacturing scene as the country’s growth driving force,” the official added.
- Company
- Janssen's Vaccines has no annual sales in 10 years
- by An, Kyung-Jin Apr 16, 2020 06:33am
- Janssen Vaccines Janssen Vaccines, which once generated annual sales of ￦300 billion through vaccine manufacturing and sales, recorded zero in sales last year. As demand for representative products, which were responsible for the company's sales, fell sharply, sales activities were virtually suspended. After the withdrawal of the Hyangnam factory in 2021, the company is willing to transform its products into cutting-edge biomedicines. According to Janssen Vaccines’ audit report submitted to the Financial Supervisory Service on the 11th, the company posted sales of ￦0 and operating loss of ￦31.6 billion last year. Janssen Vaccines plunged to ￦99 billion in 2016, ￦42.7 in 2017, and ￦27.6 billion in 2018, but sales did not occur in last year. The deficit has been continuing for four years in a row since it made an operating loss of ￦20.9 billion in 2016. Last year, the size of the deficit was the largest since its foundation. The background of Janssen vaccines’ no performance was attributed to changes in vaccine demand. The company had relied on most of its sales for two types of hepatitis B vaccines, 'Hepavax-Gene' and the pentavalent vaccine 'Quinvaxem'. Jansen Vaccine conducted the entire process from R&D of 'Hepavax-Gene' and 'Quinvaxem' to production and export of finished drugs through state-of-the-art vaccine manufacturing plants located in Songdo Free Economic Zone in Incheon. 'Hepavax-Gene' and 'Quinvaxem' obtained the Pre-qualification (PQ) from the World Health Organization (WHO) in 1997 and 2006 respectively, and In 2009, sales of vaccines jumped to ￦310 billion and operating profit of ￦113.6 billion, starting with the mass supply of vaccines to the public sector of underdeveloped countries through UN international organizations such as the UNICEF and the Pan American Health Organization (PAHO). Quinvaxem achieved exports exceeding $100 million in 2008 and boasted high demand to record the number one domestic pharmaceutical production record for six consecutive years from 2009 to 2014. However, there is currently little performance. Quinvaxem failed to win the WHO vaccine bid, and Hepavax-Gene also decided to stop supplying domestic products after consuming inventory due to a decrease in the proportion of domestic hepatitis B infections last year. An official from Janssen Vaccines said that it has been supplying only the minimum amount of vaccines from 1 to 2 years ago and has not been engaged in commercial production activities and sales of ￦26.5 billion were applied to the amount recovered from the past supply in 2018. He added that the company had decided not to make sales until the production line was reorganized. However, just because there is no sales does not mean that the company is planning to withdraw. The company plans to establish a new production line, such as anticancer drugs and next-generation vaccines, and to minimize operations until it receives approval from the US Food and Drug Administration (FDA) for pharmaceutical raw material manufacturing facilities. It is known that the withdrawal of Hyangnam Plant in 2021 opened the possibility of taking over employees who wish to transfer. It is planned to start normal production activities from 2023 as soon as possible. In fact, the Janssen vaccines invested $3 million in the Songdo plant in 2017 at the time of 2018 when Janssen Korea officially withdrew the Hyangnam plant. In 2018, the company plans to invest a similar amount of money and confirmed the establishment of a second-generation production line for Darzalex, a treatment for multiple myeloma. An official from Janssen Korea said that the company's production plans and financial decisions are confidential and it is difficult to disclose the information. The Janssen vaccines’ Incheon plant is strategically operated within the global production network and plans to continue investing in facilities.
- Company
- Drug companies and distributors conflicted over margin
- by Jung, Hye-Jin Apr 16, 2020 06:32am
- As more and more pharmaceutical companies are lowering distribution margin to save cost, a conflict between pharmaceutical companies and distributors is left unresolved. Although the two parties are continuing to negotiate on appropriate distribution margin, they end up only confirming their unyielding stances. Recently, a number of Korean and global pharmaceutical companies have reportedly notified their distributors the decision to reduce the distribution margin. Pharmaceutical companies are asking for the distributors’ understanding of the drug pricing reduction and the sales environment getting harder. However, distributors are rejecting the companies’ demand as they are also struggling with distribution cost constantly rising. Pharmaceutical company ‘A’ has notified all distributors that it would lower the distribution margin of two items by 1%p, respectively. The company A has accordingly lowered the margin from past January, but the negotiation is still open as the distribution industry is complaining the two items take up a significant part of their gross profit. A pharmaceutical company ‘B’ has notified its distributors that the discount rate on the financial expense provided for cash transaction would be adjusted. Besides the distribution margin, the company B has been providing some discount on the financial expense depending on the transaction period, but the company is to lower the discount rate. The distributors, which most of them have been paying in cash, are saying the financial expense discount rate reduction is basically a reduction in distribution margin. The distribution industry’s concern of the trend has heightened when sources reported two other pharmaceutical companies are planning to lessen the margin. The industry is also mentioning of a possible collective action against the pharmaceutical companies when the last two of them make an official notice. ◆Pharmaceutical company and distributor in their fight for survival For distributors, pharmaceutical companies lowering distribution margin is detrimental, because the distributor’s overall cost of shipping and operation would be unchanged regardless of the lessened margin. An associate of a distributor pointed out, “The current distribution margin isn’t even that high, considering the shipping, labor and logistic costs are constantly surging. The distributors dealing with pharmacies would have to give up on their businesses, if the margin is lowered.” Nevertheless, pharmaceutical companies argue distribution margin reduction is unavoidable due to the worsening sales scene. The companies are enduring increased production cost and the government's drug pricing reduction as well as the increased distribution cost. A pharmaceutical company insider commented, “The company has to inevitably adjust distribution margin due to the growing loss from the government’s pricing reduction initiatives and rising production cost. By conducting preliminary negotiation and adjustment, the company is in process of fine-tuning the distribution margin, legitimately.” Currently, the two conflicted parties have not settled on an agreement, yet. Taking into account the margin reduction directly affects profits and survival of both pharmaceutical companies and distributor, the conflict would not be resolved so easily. ◆ Individual drug company vs. distributor organization Besides the actual conflict, pharmaceutical companies feel pressured by the whole distribution industry organization opposing against the distribution margin reduction. Centering Korea Pharmaceutical Distribution Association (KDPA), other pharmaceutical distributor related organizations have joined their forces. But drug companies point out it is inadequate for an organization to interfere with a deal between individual companies and distributor. Regarding the issue, KDPA claims an intervention by an organization is inevitable, because a number of pharmaceutical companies are lowering the margin and an individual distributor is a no match against a pharmaceutical company on a negotiation table. President Cho Sun-hye of KDPA criticized, “Distributors have not demanded drug companies to raise distribution margin when distribution cost is increased. It is hard to accept the drug companies’ logic of blaming drug pricing reduction when they do not raise distribution margin with increased operating profit.” “And we want to ask if burdening distributor with reduced margin is reasonable when everyone in the whole society is struggling with the COVID-19 outbreak,” the president added. A pharmaceutical company associate, who requested to remain anonymous, said “Due to the outbreak, many of pharmaceutical companies are experiencing a steep drop in sales and they are hectic trying to overcome it.” The associate emphasized the companies are reviewing various means to save costs besides the distribution margin. “Compared to multinational companies, Korean companies are providing relatively handsome distribution margin. The companies are considering all options to save costs, including distribution, production, labor and others. Hopefully, the distribution industry can understand the situation and would try to settle on a reasonable agreement,” the associate noted.
- Company
- KDA finally agrees on SGLT2 inhibitor benefits
- by Eo, Yun-Ho Apr 14, 2020 06:15am
- SGLT-2 inhibitors approved in Korea The Korean Diabetes Association (KDA) has finally reached an agreement on expanding reimbursement on sodium-glucose transport protein 2 (SGLT2) inhibitor combination therapy. KDA has submitted a statement to the Korean government regarding the needs of expanded coverage on SGLT2 inhibitor plus off-label diabetes treatments, including dipeptidyl peptidase 4 (DPP-4) inhibitor or thiazolidinedione (TZD). The academy has begun fine-tuning their opinions on the reimbursement expansion for the SGLT2 inhibitor combination therapy after the 11th president, Professor Yoon Geon-ho (department of endocrinology at Seoul St. Mary’s Hospital), was appointed in last January. The talks on reimbursed use of the combination therapy actually was started by the medical professionals. Due to the differences in reimbursed indications among same-class drugs, the prescribers have been confused and experienced reduction in expected reimbursement and other inconveniences. Accordingly, the government has started accepting their opinion officially, but the academy itself had internal dispute. Some argued reimbursement expansion should be handled carefully on drugs without clinical evidences, regardless of other reimbursed drugs in the same class. As the closely related academy seemed to be doubtful, the government has halted reimbursement expansion discussion until now. Regarding the issue, Health Insurance Review and Assessment Service (HIRA) official stated, “Based on the statement by KDA, HIRA would further accept and review more opinions submitted by Korean Endocrine Society, other academic societies and Ministry of Food and Drug Safety that grants the approval.” Currently, there are four SGLT2 inhibitors available in Korean market—Forxiga (dapagliflozin), Jardiance (empagliflozin), Suglat (ipragliflozin) and Steglatro (ertugliflozin). Total of 36 clinical studies would have to be conducted for all combinations of therapies, based on nine DDP-4 inhibitors and the four SGLT2 inhibitors commercialized in Korea, to acquire proper data for approval according to the principle. In the same sense, combination therapies with two TZDs and four SGLT2 inhibitors should undergo total eight clinical trials.
- Policy
- Exemption of some in vivo tests when developing COVID-19
- by Lee, Tak-Sun Apr 14, 2020 06:12am
- The MFDS decided to exempt in vivo tests on some of the formulations for rapid clinical entry of COVID-19 treatments. In order to enter the clinical trial, in vitro and in vivo studies should be completed and reviewed, but in some formulations, such as antiviral drugs, in vivo studies can be replaced with existing test results. According to the industry on the 12th, the MFDS recently released a guideline on Considerations in Developing COVID-19 treatment. The MFDS provided the current position of the MFDS based on discussions conducted over the past two months to minimize trial and error by developers. and it is expected that the entry of clinical trials will provide opportunities for new drugs to work. According to the main contents of the guideline, in vivo testing is conducted in an animal model infected with COVID-19, but considering that the mechanism of action of the drug to be developed is applicable to various viruses, if it is determined that it can be applied to various viruses, In vivo test data using a viral infection animal model is accepted. For example, in the case of a drug that has already been approved and used as an antiviral agent, it is possible to enter the COVID-19 clinical trial based on in vivo test data, clinical trial data, and post-marketing experience submitted at the time of approval. However, in the case of drugs that have not been demonstrated for antiviral activity, in vivo test data using a virus-infected animal model should be secured. The Ministry of Food and Drug Safety presented examples of non-clinical trials of Remdesivir, which is conducting commercial clinical trials of COVID-19 for reference. In the case of anti-inflammatory drugs, data from animal models of virus infections other than COVID-19 are allowed, although it does not limit the type of virus, it is explained that the test results of similar viruses (influenza virus causing respiratory infection, respiratory syncytial virus (RSV), etc.) when the target organ is infected may be considered. The MFDS added that double-blind, randomized, placebo-controlled, and parallel-group trials should be considered as considerations when designing a clinical trial. This is because the current clinical trial of COVID-19 is the first dose of clinical trial drug to the patient, and the nature of the exploratory clinical trial is strong. The Ministry of Food and Drug Safety said that it would reflect relevant information if necessary after hearing opinions from various fields on the guidelines. As the Ministry of Food and Drugs exempts some data, opportunities will increase for companies seeking clinical entry as a COVID-19 treatment.
- Company
- KPBMA “Exempt transferred originals from pricing reduction"
- by Eo, Yun-Ho Apr 14, 2020 06:12am
- All of pharmaceutical industry is responding against the risk in pricing reduction on original drugs transferred due to a split-off. Pharmaceutical industry sources reported, Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA) plans to deliver an official statement to the health authority demanding the government to exempt items transferred due to corporate restructuring from the soon-to-be enforced drug pricing reduction system. The stepped drug pricing system to come in effect from July stipulates pricing 21st drug to be listed within the same substance group at 85 percent of either the lower price between the lowest price of the drugs or 38.69 percent of the original’s price, despite qualifying two differentiated pricing standards. However, a conflict fired up among the industry as the government is seemingly endorsing the legal interpretation enabling the pricing system to reduce pricing on an original drug transferred due to corporate division. Korean Research-based Pharmaceutical Industry Association (KRPIA) has already submitted a similar statement on Apr. 2. KPBMA’s statement specifically requests the Section Ma (마) of the drug pricing notice revised last February to add ‘corporate division’ as one of the exemption conditions. The Section Ma of the revised drug pricing notice stipulates an item applying for pricing decision, listed previously but de-listed, would be priced at its latest maximum price, if it is either a drug transferred by inheritance, business transfer or merge as stated by the Pharmaceutical Affairs Act Paragraph 1 of Article 89, or transferred by importer’s inheritance, business transfer or merge as stated by the Pharmaceutical Affairs Act Paragraph 2 of Article 42. Therefore, the pricing reduction would not be applied on an item transferred, along with the business license, to or by a manufacturer (typically a Korean company) or an importer (multinational company). Nevertheless, the Section Ba (바) of the notice stipulates a drug applying for pricing decision, listed previously but de-listed, would be priced at a lower price between its latest maximum price or newly calculated price, if it is transferred by the manufacturer’s business transfer as defined by the Pharmaceutical Affairs Act Paragraph 2 of Article 89. This could mean the drug reapplying for pricing could face pricing reduction depending on the number of listed generics and standard qualification stated by the drug pricing notice. But KPBMA argues the legal interpretation contradicts the true objective of stepping away from the ‘same substance-same pricing’ approach and applying differentiated pricing to value the effort of developing new drug and preventing relisting of a generic evading administrative measure and drug pricing reduction. KPBMA official said, “The number of cases where generic manufacturers resort to an expedient is also very limited. Regardless of a Korean or global company, the status of first-in-class drug (mostly new drug) should be sustained. The government needs to promptly reconsider the interpretation to prevent any confusion in the market and to follow the original objective of the regulation.”
- Policy
- Saxenda's upgraded injection (once a week) will be imminent
- by Lee, Tak-Sun Apr 14, 2020 06:11am
- Saxenda by NovonordiskSaxenda's upgraded version of the drug, which is causing a sensation in the domestic obesity treatment market, is predicting clinical trials in Korea, attracting attention. It was Ozempic (Semaglutide), which improved the convenience of administration by injection once a week. The MFDS approved IND for Semaglutide applied by Novonordisk on the 8th. The clinical trial is conducted to evaluate the efficacy and safety of Semaglutide 2.4 mg once weekly for weight management in overweight or obese subjects. This is a Phase IIIa, multinational clinical trial. Semaglutide has already been approved for clinical trials in Korea in 2018 as an indication for obesity. At the time, it was conducted on subjects in East Asia who were overweight or obese, and 40 of the 400 subjects were known to be domestic patients. The approved clinical trial seems to be proceeding with an increased dose compared to the previous clinical trial. Ozempic 0.4 mg showed a reduction effect of 13.8% in phase II clinical trials for 52 weeks, suggesting a possibility as a treatment for obesity. Ozempic, which received FDA approval for diabetes treatment in 2017, has not yet been approved for marketing in Korea. Currently, GLP-1 analogue, Saxenda (Liraglutide) are creating a sensation in the domestic obesity treatment market, raising expectations for Ozempic in domestic market. Released in March 2018, Saxenda recorded sales of ₩42.6 billion (IQVIA) last year, creating a sensation of the domestic obesity treatment market. The GLP-1 analogue drug has a mechanism of regulating appetite by reducing hunger and increasing satiety by passing the hormone GLP-1 secreted by the body into the hypothalamus of the brain upon food intake. Saxenda is a once-a-day self-injection, but Ozempic is evaluated as a convenience upgrade once a week.
- Policy
- The government, cuts health insurance premiums by 50%
- by Kim, Jung-Ju Apr 14, 2020 06:11am
- The government has decided to temporarily cut down some health insurance premiums to alleviate the economic damage of low-income and small business owners. The Ministry of Health and Welfare (Minister Park Neung-hoo) announced on the 10th that from March to May, it would reduce (30-50%) the health insurance premiums of the bottom 50% in special disaster areas and the bottom 40% in all other nationwide areas. This was in response to the announcement of the 3rd emergency economic conference announced on the 30th of the same month, with revised supplementary budget of ₩265.6 billion to support the health insurance premiums for vulnerable groups such as low-income and small business owners who suffer severe economic damage due to the recent COVID-19. On the 9th, the government revised and issued the 'Notice of Eligible Persons to Reduce Health Insurance Premiums'. Subject to the revised notice, the subjects will be reduced health insurance premiums from March to May this year, and the reductions in health insurance premiums already paid in March will be retroactively supported in April. The bottom 50% in the special disaster area is reduced by 50% of the health insurance premium, the bottom 20% in all other areas are reduced by 50% of the health insurance premium , and from the excess of the bottom 20% to 40% are reduced 30% of the health insurance premium. Through this support, the government provided a total of ₩91,559 health insurance premiums per person per month over 3 months, including 700,000 people in special disaster areas (400,000 in workplaces, 330,000 in regions), and 10.89 million in other regions (6.6 million in workplaces and 4.24 million in regions). Subjects are selected by the NHIS based on the health insurance premiums of the month without any separate application process. The MOHW and the Health and the NHIS will send a notice to the targeted people from the 13th to the 17th, so that the public can know if they are eligible, and will send out the 22nd and 25th of the April health insurance bill with a retroactive reduction in March.
- Policy
- Chong Kun Dang’s capsuled low-dose Xarelto generic approved
- by Lee, Tak-Sun Apr 14, 2020 06:11am
- Xarelto tablet 2.5mgChong Kun Dang’s generic version of Bayer’s anticoagulant Xarelto (rivaroxaban) tablet was approved as a first capsule form in Korea. The 2.5 mg low-dose capsule would be able to evade Hanmi Pharmaceutical and SK Chemical’s preferential sales rights on their generic products with the change in administration form. On Apr. 9, Ministry of Food and Drug Safety (MFDS) has reported its clearance on ChongKunDang Rivaroxaban Capsule 2.5 mg. The generic the same pharmaceutical substance rivaroxaban as Bayer’s Xarelto tablet, but it is in capsule form. Chong Kun Dang’s generic is the first capsule out of the 22 generics approved with the same substance in Korea. The Korean company has its reason why it changed the form. SK Chemicals and Hanmi Pharmaceutical have already challenged the patent and respectively received the first approvals on their SK Rivaroxaban tablet 2.5 mg and Riroxban tablet 2.5 mg, along with the preferential sales rights. SK Chemicals and Hanmi Pharmaceutical have challenged Xarelto’s pharmaceutical substance patent (expected to expire on Nov. 13, 2024) with low-dose form (2.5 mg) and won the generic market exclusive sales right (preferential sales right) for rivaroxaban. The preferential sales right’s sales ban on other generics would last from Oct. 4, 2021, when Xarelto’s first-to-file (FTF) patent on the product and the use expires, to July 3, 2022. Accordingly, generics sharing a same type of form and active ingredient with Hanmi Pharmaceutical and SK Chemicals’ generic would be ruled out from market release during the sales ban period. But Chong Kun Dang’s capsule can avoid the sales ban with a different form of capsule. Ultimately, the three Korean companies would be able to launch their generics all at the same time. Besides Bayer with the original, Hanmi Pharmaceutical, SK Chemicals, Chong Kun Dang and Hanlim Pharm had their 2.5 mg low-dose rivaroxabans approved. Currently, Hanlim Pharm is in process of patent challenge. But its generic would be banned from the sales during the preferential sales rights period. A study has confirmed 2.5 mg rivaroxaban, combined with Aspirin, reduces the risk of heart attack, ischemic stroke or cardiovascular death in patients either with coronary artery disease (CAD) or peripheral artery disease (PAD) relatively more than the Aspirin monotherapy. Based on the findings, foreign academic societies recommend using Xarelto 2.5 mg plus Aspirin in patients with high-risk chronic CAD. The demand for 2.5 mg dose is exists, but other follow-on drug makers, except for those with preferential sales rights, would be able to launch their products after Nov. 14, 2024, when the original’s patent expires. UBIST reported the mega blockbuster drug Xarelto has made 46.2 billion won last year in outpatient prescription, which is why the industry is keeping their close eye on if Chong Kun Dang would get to successfully launch the capsule-form rivaroxaban dodging the preferential sales ban.
