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- 2025-12-26 15:39:16
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- SK Chemicals sells Janssen’s Ultracet
- by Lee, Seok-Jun Feb 17, 2021 05:39am
- SK Chemicals announced on the 15th that it has signed a domestic sales contract with Janssen Korea for the anti-pain inflammatory drug Ultracet (Acetaminophen/ Trimadol HCl). According to this agreement, SK Chemicals is in charge of Ultracet distribution ,domestic marketing and sales. Janssen Korea will be in charge of production. There are 4 types of products (Ultracet, Ultracet Semi, Ultracet ER, and Ultracet ER Semi). The sales agreement between the two companies is the second following the 2019 dementia treatment Reminyl. Ultracet is one of the most widely used pain relievers in the world since it was first developed in 2002. Ultracet has a broad pain spectrum ranging from moderate to severe pain. There is no need to worry about side effects such as addiction or drug abuse because there are no narcotics that were included in many effective pain relievers. SK chemicals is co-promoting its natural drug No. 1 Joins, which is recording ₩40 billion in sales in the area of pain, and Lilly's Cymbalta (Duloxetine HCl) in Korea, thus establishing a portfolio of analgesic anti-inflammatory drugs.
- Company
- RRMS, actively expanding coverage of drugs
- by Eo, Yun-Ho Feb 16, 2021 06:07am
- There is news of expanding coverage of oral RRMS (Relapsing-remitting multiple sclerosis) drugs. According to industry sources on the 8th, after Mavenclad (Cladribine, Merck) was listed in insurance benefits in the second half of last year, Sanofi Genzyme's primary drug Aubagio was expanded from February. In the case of Aubagio, additional benefits are applied to patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who meet McDonald's diagnostic criteria through examination by a neurologist and who can go to the outpatient clinic. The key to the expansion of this benefit standard is to be able to follow the judgment of experts based on the McDonald standard diagnosis of multiple sclerosis. Aubagio's provisions that only benefit from having two or more neurological dysfunctions in the past two years have been deleted, so that patients with multiple sclerosis can benefit from Aubagio early, and access to treatment is expected to improve significantly. Mavenclad, which is recently prescribed in general hospitals, is the first to show a significant effect in terms of the progression of physical disorders, annual recurrence rate, number of active lesions shown on MRI (magnetic resonance imaging), and major disease activity indicators of RRMS patients. As a short-term oral treatment, it is taken twice for 2 years. The drug's clinical trial program included long-term follow-up data from the 8-year prospective observation registry PREMIERE study, as well as the CLARITY Phase 3 study and CLARITY EXTENSION, ORACLE MS, and ONWARD Phase 2 study corresponding to the CLARITY extended clinical trial. As a result of post-hoc analysis of patients with high disease activity in the CLARITY 2,3 study conducted for two years, the annual recurrence rate of patients receiving Mavenclad decreased by 67%, and the Extended Disability Status Scale (EDSS), which indicates the degree of disability progression. Also, the Mavenclad treatment group showed a 82% decrease compared to the control group. However, when Mavenclad is administered, lymphopenia and shingles can occur as significant adverse reactions. Therefore, patients with multiple sclerosis must measure their lymphocyte counts before and during Mavenclad administration. Mavenclad administration is contraindicated in certain populations, including patients with impaired immune function and pregnant women. A KSNI official said, "The data showed that the sales of oral drugs were far superior to those of injections in just one year. As such, patients would have chosen oral drugs in many cases."
- Company
- Generics for Xeljanz are being approved one after another
- by Kim, Jin-Gu Feb 10, 2021 06:05am
- Xeljanz Generics for Xeljanz (Tofacitinib) are being approved one after another. After crystalline form patent was deleted from the list, it seems that domestic companies are competitively receiving generic licenses. According to the MFDS on the 9th, until this day, a total of 42 generics for Xeljanz have been licensed. Since Boryung's generic was first approved in August of last year, it has continued steadily. Generics have increased rapidly since last December. After GL Pharma on December 23, in about a month or two, 31 companies were granted generic licenses. About half of these are companies that commissioned production to Boryung. Boryung plans to consign products from 16 companies including Korea Prime at Ansan Plant 1. Xeljanz has product patent that expires in November 2025 and crystalline form patent that expires in November 2027. Many domestic companies have challenged the patent. The challenge for crystalline form patent developed in two tracks. 20 companies, mainly Chong Kun Dang, requested an invalidation trial, and 16 companies, including Boryung, requested a passive trial to confirm the scope of rights. In January 2018, as a result of a trial for the passive scope of rights, generics succeeded in evading patent for Xeljanz. The result of the invalidation trial was also won by generics in November 2019. This decision was confirmed in January 2020. Following the decision of invalidation, crystalline form patent for Gelzanz was deleted in March last year. The barrier to the Crystalline Form Patent, which expires in November 2027, has disappeared. Companies that have succeeded in developing generics will be able to release generics after November 2025, when the product patent expires. Considering that there are more than four years left until the expiration of the product patent, there is a high possibility that generic licenses from other pharmaceutical companies will be added. Xeljanz is a JAK inhibitor family of autoimmune diseases. It is released as an oral preparation in the autoimmune disease treatment market, which is mostly an injection, and has overcome the limitations of existing TNF alpha inhibitors. According to UBIST, the amount of outpatient prescriptions last year was ₩12.6 billion. Since its launch in the domestic market in July 2015, Xeljanz has rapidly increased its prescription performance to ₩1.7 billion in 2016, ₩3.3 billion in 2017, ₩8.3 billion in 2018, and ₩12.6 billion in 2019. However, compared to 2019, in 2020, it was stagnant, and this is analyzed due to the addition of Olumiant (Baricitinib) from Lilly. And, no domestic companies have challenged patent of Olumiant.
- Company
- Despite COVID-19 and NDMA metformin prescription surges
- by Chon, Seung-Hyun Feb 10, 2021 06:04am
- Metformin-based antidiabetic drugs showed exceptional growth in the prescription drug market. Both metformin combination and single agent drugs expanded their prescription volume and maintained the credibility in the clinical scene, regardless of the novel coronavirus disease (COVID-19) outbreak and impurity contamination incident. On Feb. 9, a pharmaceutical market research firm UBIST told the outpatient prescription volume in metformin last year marked 535.7 billion won growing 9.5 percent from the previous year. The year 2019 showed a growth of 7.3 percent. Metformin, a type of biguanides, is used vastly on Type 2 diabetic patients as a first-line treatment to control the blood sugar level. Amid COVID-19 pandemic last year, the general prescription drug market fluctuated but the metformin market growth surged. Both metformin and single agent drugs showed definite growth. In last year, metformin single agent drug generated 77.3 billion won, showing a 4.1-percent growth compared to the year before. The growth was increased steeply compared to 2.9 percent growth made in 2019. Meanwhile, the metformin combination drug market had even higher growth. The last year’s metformin combination drug prescription volume grew by 10.5 percent from the year before and made 458.4 billion won. In 2019, the volume grew 8.2 percent compared to previous year. The combination drug market surged by 96.8 percent throughout five years from 2015 making 232.9 billion won. Currently, there are metformin drugs combined with dipeptidyl peptidase 4 (DPP-4) inhibitors, sulfonylureas, glitazone and sodium-glucose co-transporter-2 (SGLT2) inhibitors available in the South Korean market. Among all combination drugs, DPP-4 inhibitor plus metformin drug market had a notable growth. In last year, the DPP-4 inhibitor plus metformin drug prescription volume generated 380.5 billion won, growing by 5.8 percent compared to the year before. In five years from 2015, the market expanded exponentially by 90.5 percent. The DPP-4 inhibitor plus metformin drugs dominates 71.3 percent of the metformin combination drug market share. The SGLT-2 inhibitor plus metformin drug prescription volume also surged by 59.1 percent in last year and made 44.4 billion won. Although metformin drug market suffered a detrimental hit by the impurity contamination, the prescription market firmly consolidated its ground. South Korea’s Ministry of Food and Drug Safety (MFDS) ordered temporary manufacturing and sales suspension and prescription limitation on 31 metformin active pharmaceutical ingredient and complete products supplied in South Korea, as the ministry discovered unacceptable level of N-Nitrosodimethylamine (NDMA) carcinogen in the drugs. The sales ban was imposed on JW Pharmaceutical’s Guardmet, Hanall Biopharma’s Glucodaun OR Tablet and Hutecs Korea Pharmaceutical’s Gluless-M. The order was issued six months after the Singaporean health authority raised an issue of metformin impurity contamination. In December 2019, Singapore’s Health Sciences Authority (HSA) investigated 46 metformin-contained items on sale and recalled three items as they found NDMA exceeding the acceptable daily intake level. Since then, MFDS also started investigating metformin ingredients and complete products in South Korea. The relevant industry was concerned when the South Korean health authority initiated the investigation as it could affect the metformin prescription market. In fact, an anti-hypertension drug valsartan was also found with unacceptable level of impurity and the general market was impacted by the authority’s sales ban order. In July and August 2018, MFDS banned the sales of 175 valsartan single agent drugs and combination drugs using ingredients found with NDMA. Valsartan containing anti-hypertension treatments generated 381.9 billion won in 2017, but the volume continued to slip for two consecutive years in 2018 and 2019 at 376.4 billion won and 332 billion won, respectively. But in last year, the volume increased by 4.0 percent compared to 2019 making a positive growth after three years. Metformin is the only oral antidiabetic drug used for first-line treatment. Basically, the absence of alternative option has protected the drug’s credibility against the impurity incident. Also the sales ban on metformin drugs was limited compared to the overall market. MFDS reported the 31 items banned from sales generated production volume of 22.8 billion won in 2019. It was only 6 percent of the overall production and import volume. And other plenty of options were available, besides the banned items, for the prescription market to have avoided confusion. The industry evaluates the previous experiences of impurity contamination in valsartan, ranitidine and nizatidine have taught the market such incident’s risk is insignificant. When announcing the list of impurity-contaminated metformin items to be banned, MFDS concluded “The harmful risk on human body by long-term exposure to drugs found with unacceptable level of NDMA is miniscule.”
- Company
- More options for ankylosing spondylitis including Taltz
- by Feb 09, 2021 06:04am
- The interleukin 17A (IL-17A) inhibitor drugs are taking over the spotlight in the ankylosing spondylitis treatment market. Besides the first-in-class Cosentyx (secukinumab), Taltz (ixekizumab) was released to the South Korean market with its strong evidences. Some specialists predict the guideline, initially recommending the drug to be used after using tumor necrosis factor-alfa (TNF-α) inhibitor, could be changed. One of the most frequently diagnosed rheumatic diseases, ankylosing spondylitis mostly uses a nonsteroidal anti-inflammatory drug (NSAID). But a biologic drug is recommended for patients with high disease activity. Humira (adalimumab) and Remicade (infliximab) are TNF-α inhibitors, a most commonly used biologic treatment type. Although the drugs are recommended first with their credible amount of clinical data, 30 percent of the patients apparently do not respond to TNF-α inhibitor. Professor Hong Seung-jae at Kyung Hee University Medical Center (Department of Rheumatology) says only one out of three patients maintain the treatment, two years after using biologic treatment. 40 percent of the patients suspend the treatment before starting the second cycle, because of insufficient efficacy. And now IL-17A inhibitors are emerging as a new option. 16 years after a first TNF-α inhibitor was approved, Novartis’ Cosentyx was released as a new drug to treat patients with ankylosing spondylitis. And Eli Lilly’s Taltz followed with a same indication, and joined the competition in the South Korean market as received the National Health Insurance (NHI) reimbursement in last October. Taltz’s strengths in treating ankylosing spondylitis are exceptional level of efficacy and safety. To confirm the efficacy and safety in treating the disease, the COAST-V study had patients who are biologic disease-modifying antirheumatic drug (bDMARD)-naïve, and the COAST-W study had patients who previously had an inadequate response or were intolerant to TNF inhibitors. Both studies chose more stringent primary endpoint, unlike other preceding clinical trials on ankylosing spondylitis, which was the Assessment of Spondyloarthritis International Society 40 (ASAS40) response showing over 40 percent improvement in the patients’ symptoms. The trials were the only and first studies to have set ASAS40 as a primary endpoint. Patients achieving ASAS40 at week 16 The Taltz group in two studies achieved 48 percent and 25 percent of the ASAS40 response at week 16, respectively, and 53 percent and 34 percent at week 52. The results indicated statistically meaningful improvement compared to the placebo group. Taltz also resulted in statistically significant outcome in secondary endpoints—objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), as well as patient-reported outcome (PRO). And a head-to-head COAST-V study compared the drug against a TNF-α inhibitor Humira, frequently used to treat patients with ankylosing spondylitis. Ultimately, the Taltz patient group showed higher response rate compared to the Humira patient group. Moreover, Taltz has notable safety profile. A TNF-α inhibitor is banned on patients with severe heart failure, whereas Taltz can be used regardless of the underlying condition. Professor Hong Seung-jae elaborated, “Once-biweekly administered Taltz is more convenient than other once-weekly drugs, and it is known for its high ASAS40 response proving the efficacy. And because it does not have the safety issue the TNF-α inhibitors, the drug can be administered to patients with heart failure.” When the clinical records of Taltz accumulate in the future, the professor thinks the reimbursement and treatment guideline can be easily changed. Currently, Taltz is indicated for use in both first and second-line treatment, but the NHI reimbursement is granted only for using when a patent shows no response to a TNF-α inhibitor. Also, the guideline by the Assessment of SpondyloArthritis International Society/ European League against Rheumatism (ASAS/EULAR) recommends using TNF-α inhibitor with more extensive clinical data, and then recommends an IL-17A inhibitor if the patient does not react to the TNF-α inhibitor. Professor Hong expressed his anticipation in the prospective changes in the reimbursement standards, and said “The healthcare reimbursement standard and overseas guideline categorize the drug as a second-line treatment, as it lacks sufficient amount of clinical data in South Korea. But the data is accumulating globally, and some experts claim the drug should be used at a same level with TNF-α inhibitor.” Meanwhile, relevant experts project other biologic treatment could become a variable in the expansion of an IL-17A inhibitors in the ankylosing spondylitis treatment market. Currently, various Janus kinase inhibitors, such as tofacitinib and upadacitinib, are in process of conducting clinical trials targeting ankylosing spondylitis. Specifically, upadacitinib (brand name Rinvoq) was indicated in EU to treat patients with ankylosing spondylitis, showing off its intention to join the scene. Unlike other biologic treatments, orally taken JAK inhibitor could be preferred more.
- Company
- What now for Vyndamax failing essential drug designation?
- by Eo, Yun-Ho Feb 08, 2021 06:08am
- A transthyretin amyloid cardiomyopathy (ATTR-CM) new drug Vyndamax (tafamidis) seems to be struggling to receive National Health Insurance (NHI) reimbursement in South Korea. A pharmaceutical industry source reported Pfizer’s new drug treating patients with ATTR-CM Vyndamax (tafamidis 61 mg) has failed to get a treatment-purpose essential drug designation. But as Vyndamax has comparatively normal patient size, it would be unlikely to get listed for reimbursement with the pharmacoeconomic evaluation (PE) exemption. Approved in South Korea to treat patients with transthyretin amyloidosis with polyneuropathy (ATTR-PN) in October 2018, Vyndaqel (tafamidis 20 mg) has highly limited patient size for the hereditary type, but its indication can cover wild type caused by old age. Now the problem is on patients. ATTR-CM is considered to have bad prognosis as the patients tend to only survive two to 3.5 years after the diagnosis, or sometimes they are misdiagnosed as simple heart failure and result in detrimental outcome. Vyndamax is basically a treatment option for ATTR-CM. The patient size is extremely limited and they rely or either liver transplant or allopathy. And a multicenter, placebo-controlled Phase III ATTR-ACT study confirmed Vyndamax lowering the risk of cardiovascular event and improving the results of 6-minute walk test. The next action for the expensive drug is up to the government and the pharmaceutical company. Although the subject criteria for PE exemption are widening, the industry still sees a room to grow. If an immediate regulation revision is difficult, the two parties should assertively talk about models fitting the unique quality of drug, such as using a variety of risk sharing agreement (RSA) types. The ATTR-ACT study randomly assigned 441 patients to be administered with 80 mg or 20 mg of tafamidis or placebo in 2:1:2 ratios. The primary endpoint evaluated the frequency of cardiovascular related death and hospitalization. The secondary endpoint was the change in the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score from 6-minute walk test taken and compared among the baseline time to 30-month point. In the study, the tafamidis statically improving the lowered risk of death by all causes and hospitalization, compared to the placebo group.
- Company
- Oncaspar for acute lymphocytic leukemia was approved
- by Eo, Yun-Ho Feb 08, 2021 06:08am
- According to the related industry, Servier Korea's Oncaspar (Pegaspargase) was approved from the MFDS as a rare specialty medicine as a combination therapy with other anti-tumor drugs when treating Acute Lymphoblastic Leukemia (ALL) in children and adults under the age of 8 years. Oncaspar is a drug that dramatically reduces the frequency of administration so that it is administered once every 14 days compared to L-asparaginase, which was previously administered once every other day by maximizing the drug circulation half-life through PEGylation. Considering the high incidence rate of acute lymphocytic leukemia, especially in pediatric patients, it is expected to alleviate the physical pain of pediatric patients suffering from frequent chemotherapy and hypersensitivity reactions from injection because it can be administered every 14 days. In addition, it is expected to have a positive effect on medical expenses such as hospital visits or hospitalization for injection treatment. First approved as a second line treatment for acute lymphocytic leukemia in the United States and Germany in 1994, Oncaspar was recognized as the first line treatment for all acute lymphocytic leukemia in the United States in 2006. Since its birth in Europe in 2016, it has been approved as a combination therapy with other anticancer drugs in 18-year-old children and adults with acute lymphocytic leukemia. Currently, it is recommended first in major international guidelines and treatment protocols such as NCCN, ESMO and Children's Oncology Group (COG) as a treatment for acute lymphocytic leukemia, and is being used in 62 countries. An official from Servier Korea said, "In Korea, patients or guardians have individually applied for Oncaspar through the KOEDC and received limited supply of Oncaspar. Servier Korea has provided Oncaspar to Korean patients with acute lymphocytic leukemia, so we are able to provide a stable supply.”
- Company
- Sanofi disturbs distributors with first vaccine bidding
- by Feb 08, 2021 06:08am
- Sanofi Pasteur, a first pharmaceutical manufacturer to jump into the vaccine bidding market and stir up the pharmaceutical distributor industry, could not ink the final procurement agreement. The company dropped its agreement offer as it failed to meet the bidder qualification standards. A pharmaceutical distributor industry reported on Feb. 4, although Sanofi Pasteur won the military camp hepatitis A virus vaccine procurement bidding via the Korea Online E-procurement System late last month, the company did not pass the bidder review. Valued at 6.3 billion won, the bidding was intensely competitive with total 47 companies participating. And Sanofi Pasteur was the only pharmaceutical manufacturer among pharmaceutical distributor bidders. Sanofi Pasteur apparently offered the lowest price among all bidders (80.576 percent of the previously procured price), and was selected as a top choice. And the pharmaceutical distribution industry was thrown into turmoil as the multinational pharmaceutical manufacturer won the initial bidding. So far, by tacit agreement, the vaccine bidding market was exclusively owned by distributors. But Sanofi Pasteur broke the unspoken rule and entered the bidding. And because of the surprise participation, the general bidding price dropped. Sanofi Pasteur also joined the meningococcal vaccine bidding opened around the same time. The company did not win the bidding, but the distributor industry definitely noticed the shocking action. Regarding the distributor industry’s fierce disapproval, Sanofi Pasteur firmly responded the direct bidding participation is not problematic, but the company had an unforeseen issue. The Public Procurement Service selected the multinational company as a top choice, but the manufacturer failed to meet certain conditions. The government agency official said, “Sanofi Pasteur voluntarily withdrew from the bidding due to unqualified review score. The agency is currently reviewing the second choice of the bidder.” It indicated the end of Sanofi Pasteur’s attempt in the bidding, but the industry is still tensed up from the happening, because a pharmaceutical manufacturer directly bidding for a government procurement deal could threaten the existence of the distributor industry. The manufacturer also mentioned of possibly participating in other biddings in the future. On Feb. 3, the Vaccine Business Committee associated under Korea Pharmaceutical Distribution Association was convened to talk about response strategy against similar prospective issues. The committee stressed mutual understanding and consideration from the vaccine manufacturer and importer are needed, and agreed that the government and each pharmaceutical company should clarify their scope of bidding. Particularly, the current bidding system only stipulates the basic qualification for the bidders to be a pharmaceutical wholesale distributor. The committee members raised their voices that the regulation should be amended to consider a bidder’s refrigerated transportation and vaccine distributing capacity to properly select the winning bidder. A pharmaceutical distributor industry insider said, “At the moment, the number of vaccine distributors is limited. But if manufacturers start taking over the bidding, then vaccine distributors would be unable to survive the market. Pharmaceutical manufacturers and distributors should form to a mutual relationship.” The association plans to disseminate official statement to each manufactures to request for cooperation, and to file a formal complaint to the authority to revise the relevant regulation.
- Company
- What is the expert evaluation of the single dose COVID-19 va
- by Whang, byung-woo Feb 08, 2021 06:07am
- Johnson & Johnson's COVID-19 vaccine, which has the advantage of a single vaccination, has been evaluated as not as expected, revealing 66% of the preventive effect. Experts are suggesting that approval is expected as long as they exceed the minimum standards of the WHO, but the evidence should be supplemented. On the 29th, Johnson & Johnson released the results of clinical trials for its vaccine (Janssen vaccine) at local time. Clinical results show that this vaccine has an average of 66% prophylactic effect (72% in the US, 66% in Latin America, and 57% in South Africa). These results are relatively low compared to Pfizer 95%, Moderna 94.1%, and Novavax 89.3%, which is not good even considering the strength of single dose. This is same as when there was an announcement that AstraZeneca's COVID-19 vaccine had a prophylactic effect of about 62%. However, experts explain that the Janssen vaccine can be approved based on the efficacy criteria of the vaccine published by the WHO. Choi Won-seok, a professor of infectious medicine at Korea University Anam Hospital, said, "When COVID-19 vaccine was first developed, the criterion that we thought we could respond to the epidemic was about 50% of the prevention effect. All the vaccines available so far, including Janssen, have exceeded this standard." He said, "The standard for responding to COVID-19 epidemic is 70%. Janssen recorded an average of 66%, but in the US clinical trials, the result was more than 70%, so it will meet the US Food and Drug Administration (FDA) standards." Johnson & Johnson plans to apply for Emergency Use Authorization from the Food and Drug Administration (FDA) as early as this week, and a preliminary review has been requested in Korea. In this regard, Kang Jin-han, director of the Vaccine Bio Research Institute at Catholic University of Medicine, said, "It is said that if the vaccine prevention effect is more than 50%, it is normal and it is good if it is more than 70%. if the prevention effect is more than 50%, it will be approved." However, he said that while evaluating that a single dose of Janssen vaccine is meaningful, it is also clear that the preventive effect is lower than expected. He said, "The data aren't all public and can't be concluded. The evidence is not clear on how long a single dose lasts independent of the seroconversion rate. It should be said that the preventive effect should be sustained like the two doses, but it is unfortunate that this part is not clear." The Janssen vaccine is a single vaccination and is easy to distribute and store. Who is vaccinated? In addition to the single vaccination, the Janssen vaccine has the advantage of being easy to set up an inoculation plan because it remains effective for more than 3 months in refrigerated distribution and storage, and is delivered in a 5-dose vial package that does not require dilution. The vaccine for 6 million people will be supplied from the second quarter, and Johnson & Johnson is confident that there will be no disruption in the contracted supply. Experts believe that it is effective to first inoculate the elderly living in the facility. Professor Wonseok Choi said, "It is difficult to judge a specific profile before knowing it, so we should prioritize storage and accessibility. However, if there is a limited supply and there is no option of a vaccine, we have no choice but to inoculate at the currently selected priority." He stressed, "If the characteristics of each vaccine are similar and do not have a significant effect, we will have to prioritize vaccination, which shows clinically more effective."
- Company
- Elyson challenges patent of Entresto
- by Kim, Jin-Gu Feb 05, 2021 10:09am
- Novartis' heart failure treatment Entresto (Sacubitril / Valsartan) is expected to be challenged by domestic companies. Interest is focused on whether domestic companies can overcome Entresto's patents, in which a total of 4 patents are registered. According to the pharmaceutical industry on the 4th, Elyson recently filed a judgment against Novartis to confirm the scope of passive rights against Entresto's crystalline patent. In addition to this patent, which expires on September 21, 2027, a total of four patents for Entresto are registered. Product patent expired in July 2027, and two patents for composition expired in November 2028 and January 2029. It is explained that the remaining three patents must be overcome in order to early release generic for Entresto. If all four patents are successfully overcome, Elyson will be able to release the generic after April 13, 2022, when Entresto's PMS expires. Entresto is a heart failure treatment that Novartis launched in Korea in October 2017. In fact, after recording an outpatient prescription amount of ₩6.3 billion in 2018, the first year of its release, it has grown more than three times in two years to ₩20.3 billion last year. For this reason, many domestic companies have shown interest in launching generic for Entresto. It is reported that some companies have also initiated biological equivalence tests. However, there was no company that started a patent challenge. Elyson is expected to challenge the patent of Entresto, which will add challenges from other companies. A pharmaceutical industry official said, "Since last year, not a few pharmaceutical companies have shown interest in patent challenge for Entresto. With Elyson's first patent challenge, there is a possibility that other pharmaceutical companies will continue the patent challenge in about two weeks to meet the initial request for trial."
