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Company
Forxiga's patent war ended after eight years
by
Kim, Jin-Gu
Feb 13, 2023 05:59am
The Supreme Court sided with Generic in the dispute over Forxiga patents for SGLT-2 inhibitor-based diabetes treatment. Patent challengers will be able to release generics early after April 7. The Supreme Court's special second division ruled in the morning of the 2nd that AstraZeneca would dismiss the appeal in an appeal filed against 17 companies, including international drugs. Forxiga is protected by two substance patents. The first substance patent (10-0728085) expires on April 7, 2023, and the second substance patent (10-1021752) expires on January 8, 2024. In March 2015, 17 companies, including Kukje Pharmaceutical, filed a trial for invalidation of the second substance patent. In the first trial, generic companies won. In August 2019, the Patent Tribunal made a trial decision on the establishment of the claim. AstraZeneca objected. The patent court, which is the second trial, also sided with generic companies. The Patent Court ruled against the plaintiff in October 2020. The Supreme Court also sided with generics following the first and second trials. This effectively ended the eight-year patent dispute. The ruling will allow patent challengers to release Forxiga generics early after April 7, 2023, when the first substance patent expires. Generics have already overcome all the remaining patents. Generics won the first trial in August 2020 and even received generic for exclusivity. This means that SGLT-2 inhibitor-based generics will pour into the diabetes treatment market after April.
Company
Daewoong Nabota has obtained an item license in Singapore
by
Kim, Jin-Gu
Feb 13, 2023 05:59am
Daewoong Pharmaceutical announced on the 9th that its botulinum toxin "Nabota" obtained an item license in Singapore on the 20th of last month. The acquisition of Singapore permits was the first of its kind among domestic botulinum drugs, and Nabota has increased the number of licensed countries worldwide to 62. Nabota 100 units are approved by the Singapore Health and Science Agency (HSA). Daewoong Pharmaceutical applied for an item license in September 2021. Daewoong Pharmaceutical plans to release Nabota in Singapore in the third quarter of this year. Hypens Pharma Pte Ltd is in charge of local distribution and sales. Hypens Pharma is a subsidiary of the SGX-listed Hypens Group. Compared to other Southeast Asian countries, Singapore has a smaller botulinum toxin market. However, as the beauty and medical industries are developed with high national income, it is considered a strategic point for expanding the regional market. For this reason, it is expected to gradually expand to neighboring countries and increase brand awareness. Park Sung-soo, vice president of Daewoong Pharmaceutical, said, "Singapore has a great influence on the Southeast Asian beauty and medical industry," adding, "Not only is it meaningful in that it is the first botulinum toxin brand in Korea to obtain Singapore approval, but it is expected to accelerate Nabota's market expansion in Asia." Nabota is a botulinum toxin preparation that Daewoong Pharmaceutical released in Korea in 2014. It is the only FDA-approved in Asia as well as in Korea. As of February 2023, 62 countries, including the United States and Europe, are providing excellent beauty and treatment options, and Singapore is also expanding its global business by obtaining permission.
Company
Generic for Dukarb is coming soon
by
Kim, Jin-Gu
Feb 13, 2023 05:58am
According to the second trial decision of Dukarb on the 16th of this month, it is decided whether to release the core capacity at the same time. With Boryung Kanarb's generic set to be released next month, attention is focused on the second trial of the patent dispute, which is three days away. This is because the decision of the patent court determines whether to release the Dukarb generic core capacity at the same time. ◆Dukarb's generic will be released sequentially after registering next month's benefit According to the pharmaceutical industry on the 13th, the material patent of Boryung Kanarb expired as of the 1st of this month. In principle, a generic for Kanarb has become available. In addition, the remaining generics, except for the core capacity of Dukarb, which is protected by patents for composite compositions, will also be available. The drug that generics are paying attention to is Dukarb. Currently, 27 pharmaceutical companies have been licensed for 72 items of Dukarb generics with different capacities. No single-system Kanarb Generic has been licensed. They received permission for related products from December to January this year. He then applied for a salary registration with the HIRA. According to related regulations, Health insurance benefits will be announced two months after the date of application and will be applied as of the 1st of the following month. Since generic companies applied for salaries in December last year, it will be announced at the end of this month and the salaries will be applied from the 1st of next month. As a result, Dukarb generic is expected to be released sequentially after next month. Products from the four companies approved in December last year are expected to be released first on the 1st of next month, followed by products from the remaining 23 pharmaceutical companies on April 1. The pharmaceutical industry's attention is focused on the second trial of the Dukarb patent dispute, which is just three days away. This is because the ruling determines whether Dukarb's core capacity will be released simultaneously. Dukarb is protected by a patent that expires in 2031. However, the scope of this patent is limited to Dukarb 30/5 mg. Except for this capacity, the rest can be released after the 1st of next month regardless of the 2nd trial ruling. The key is the 30/5 mg product. If the patent court sides with Generic on the 16th of this month, Generic can release 27 items of Fimasartan and S-Amlodipine 30/2.5mg products simultaneously as other generics. In the case of S-Amlodipine, it is interpreted as half the dose of Amlodipine. The combination of Fimasartan and S-Amlodipine 30/2.5mg chosen by generics means that it is virtually the same drug as the original drug Dukarb's 30/5mg. If the court sides with Boryung in the second trial following the first trial, the timing of the release of the 30/2.5mg product by generics will be postponed. The product can be released only when generic companies win a reversal decision from the Supreme Court through an appeal or win a separate invalidation trial. If both methods fail, the capacity product may not be released until 2031, when the Dukarb patent expires. According to UBIST, a pharmaceutical market research firm, Dukarb's prescription last year was 46 billion won. Boryung explains that more than half of the performance comes from 30/5mg products, which are core doses.
Company
GC Pharma reinforces sales partnerships
by
Kim, Jin-Gu
Feb 13, 2023 05:58am
GC Pharma has been strengthening partnerships with pharmaceutical and biohealth companies in Korea and abroad by signing a series of copromotion agreements. After the company signed a copromotion agreement for GSK’s shingles vaccine ‘Shingrix’ at the end of last year, the company recently also signed an agreement to copromote Sanofi's anti-platelet agent ‘Plavix.' Also, earlier this year, the company expanded its sales agreement with BMS on selling the company’s hepatitis B treatment, ‘Baraclude.’ The industry interpreted this as the company’s move to diversify its business structure, focusing on blood derivative products and vaccines and securing a cash cow through external expansion. ◆Will copromote Shingrix and Plavis...expanded sales agreement for Baraclude According to industry sources on the 11th, GC Pharma has been jointly selling Sanofi’s anti-platelet agent Plavix (clopidogrel) from the first of this month. Under the copromotion agreement, GC Pharma is responsible for local sales, and Sanofi for sales at large hospitals. Plavix has been generating KRW 120 billion in the outpatient prescription market in Korea. According to the pharmaceutical market research institution UBIST, Plavix sold KW 117.6 billion last year, ranking fourth among all prescription drugs sold in Korea last year. (From the left) Shingrix, Plavix, Baraclude Also, the company had signed a copromotion agreement for GSK’s shingles vaccine Shingrix with GSK and Kwangdong Pharmaceutical and started joint sales of the drug in earnest in December last year. Shingrix has been gaining attention as a new premium vaccine in its area. It has shown a near 97% efficacy, twice higher than that of other existing shingles vaccines, and has demonstrated its long-term effect and safety. It had already raised KRW 2.26 trillion in sales in the global market in the first half of last year, which is near the KRW 2.70 billion that the vaccine had made in the previous year. Earlier this year, the company expanded its sales agreement for the hepatitis B treatment Baraclude with BMS. The company, which had previously jointly sold the product with BMS in the past, will exclusively distribute and sell the drug from this year. Therefore, the company will be selling the drug to all medical institutions including general hospitals in addition to local hospitals and clinics in Korea. Baraclude is a hepatitis B treatment that contains entecavir. The drug sold KRW 71 billion in prescriptions last year. Although its generic version has been released in the market after patent expiry, the original drug continues to exert an overwhelming influence in the market. Last year, it ranked second in sales in the market after Gilead Sciences Viread (KRW 89.5 billion). ◆Suceeds in joint sales of its self-developed Neulapeg·Shinbaro with domestic companies The company has also been strengthening partnerships with domestic pharmaceutical companies. GC Pharma has been adopting the strategy of jointly selling its self-developed drugs with domestic pharmaceutical companies. Neulapeg and Shinbaro are representative examples of such activity. Neulapeg is a treatment for Neutropenia that had been self-developed by GC Pharma. It is a biobetter product that is an upgraded version of the original drug, Kyowa Kirin’s Neulasta. It has improved purity and stability compared to existing treatments and reduced the drug’s half-life over existing drugs. GC Pharma has been jointly selling Neulapeg with Boryung Pharmacuetical until 2021, then with Jeil Pharmaceutical from last year. Its sales had surged during its partnership with Boryung Pharmacuetical. Its sales, which had been less than KRW 1 billion every quarter until 2018, surged to nearly KRW 6 billion in 2021 and exceeded that of the original version by Q4 2021. ◆ Strategies to fill the gap derived from non-sale of MSD vaccines + expanding business portfolio The domestic sales license transfer of the 3 MSD vaccines is pointed out as the background for GC Pharma’s recent moves. Until 2020, GC Pharma had been copromoting 3 of MSD’s vaccines: the shingles vaccine Zostavax, and cervical cancer (HPV) vaccines Gardasil 4 and Gardasil 9. Sales of the 3 vaccines reached KRW 106.1 billion in 2020. However, MSD changed its domestic copromotion partner for the three vaccines to HK inno.N in 2020. Since then, the company has been actively filling the gap that occured in its revenue by making new copromotion agreements. In the mid-to-long term, this is also in line with GC Pharma’s recent business structure diversification strategy. GC Pharma has recently been aggressively strengthening its prescription drug business. It plans to expand its business portfolio, focusing on existing blood derivative products and vaccines. Due to the heavily export-dependent nature of blood derivative products and vaccines, the disadvantage is that its sales are volatile depending on the overseas performance and period. This is why the company has established a mid-to-long strategy to expand its field to prescription drugs and secure a new cash cow.
Company
Can Jakavi be reimbursed for GvHD within the year?
by
Eo, Yun-Ho
Feb 13, 2023 05:58am
Whether reimbursement of ‘Jakavi’ be extended to cover Graft versus Host Disease (GvHD) is gaining attention. Novartis Korea submitted an application to extend reimbursement of its Jakavi (ruxolitinib) to GvHD immediately after receiving approval for the indication in May 2022. However, 8 months have passed and no progress has been made at the Health Insurance Reimbursement and Assessment Service’s level. Therefore, whether the agenda will be deliberated during HIRA’s Drug Reimbursement Evaluation Standard Subcommittee meeting that is expected to be held within the week is gaining attention. When considering the remaining review process, it may be difficult to extend the drug’s reimbursement within the year if HIRA does not complete evaluations by the first half of this year. GvHD is a potentially serious complication that may occur after allogeneic stem cell transplantation (allo-SCT). The donor’s T cells (the graft) view the patient’s healthy cells (the host) as foreign and attack and damage them, affecting various organs including the skin, the gastrointestinal tract, the liver, and the lungs. As symptoms can appear throughout the body, GvHD poses another challenge to patients who have survived allogeneic hematopoietic stem cell transplantations by affecting the patient’s quality of life. Steroids are used as standard first-line therapy, but unmet needs exist as no standard therapy exists in the second-line for the 50% of patients that fail treatment in the first-line. In this area, Jakavi arose as an option that can be used to treat patients aged 12 years and older with acute or chronic GvHD who have an inadequate response to corticosteroids or other systemic therapies. Hee-Jae Kim, the Chief Chair of the Korean Society of Blood and Marrow Transplantation (Professor of Hematology at the Catholic University of Korea), said, “Jakavi demonstrated superior effect in treating acute and chronic GvHD patients in clinical studies and has shown similar outcomes in the field, opening up new possibilities for patients suffering from lack of an appropriate treatment option” He added, “Treatment access to Jakavi has been restricted in Korea due to its non-reimbursement. A considerable amount of time has passed since its approval, and Jakavi’s reimbursement should be applied as soon as possible so as not to further increase the burden of the patients that have already suffered enough, from hematopoietic stem cell transplantation to GvHD.” Meanwhile, Jakavi has demonstrated its efficacy in the Phase III REACH2 trial. Results showed that the overall response rate with Jakavi at Day 28 was 62%, which was higher than the 39% that was achieved with the best available therapy (61/155) Also, the durable overall response was found to be nearly twice higher in the Jakavi group at Day 56 at 40% (34/155), compared with the 22% (61/154) in the control group.
Company
One step left to Dupixent’s reimb in pediatric patients
by
Eo, Yun-Ho
Feb 10, 2023 05:53am
The atopic dermatitis treatment ‘Dupixent’ has entered the last phase of extending its reimbursement coverage to children and adolescents. According to industry sources, Sanofi-Aventis Korea is conducting drug pricing negotiations for the low-dose formulation (200mg) of Dupixent (dupilumbab) with the National Health Insurance Service. The reimbursement agenda has made smooth progress after passing deliberation by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service on the 12th of last month. When considering the set negotiation period, the results are expected to come out by March. Being an RSA (Risk Sharing Agreement) drug and the addition of the separate 200mg dose, the drug had to pass HIRA’s cost-effectiveness review process and complete drug pricing negotiations with the National Health Insurance Service to receive reimbursement. If the drug successfully completes drug pricing negotiations, Dupixent will finally be able to see results two years after applying for the reimbursement extension in April 2021. The journey had not been so easy for the drug. IT first took 7 months for expert opinion inquiries to begin on extending reimbursement of Dupixent to pediatric and adolescent patients, and the reimbursement standards for the indication were only set in May last year. Although the specific indications may differ, the difference in speed of progress is evident when compared to other JAK inhibitors that applied for reimbursement extensions in atopic dermatitis, such as Lilly Korea’s ‘Olumiant (baricitinib),’ Abbvie Korea’s ‘RInvoq (upadacitinib)’ etc. The price of JAK inhibitors is also relatively lower than that of Dupixent. The two drugs were both listed for reimbursement in May last year and Rinvoq is also attempting to extend its reimbursement to pediatric adolescent patients. Meanwhile, the 300mg dose of Dupxient is currently reimbursed for adult patients aged 18 years or older with chronic severe atopic dermatitis who have had the condition for over 3 years and satisfy all three of the following criteria: ▲ who are unable to control their symptoms after receiving topical treatment for over 4 weeks, and ▲ unable to use systemic immunotherapies due to side effects or saw no response (50% or more decrease in EASI, EASI 50) after receiving treatment with systemic immunotherapies, and ▲ had an EASI score of 23 or higher before administering Dupixent.
Company
Botulinum Xeomin can be stored at room temperature
by
Jung, Sae-Im
Feb 10, 2023 05:52am
Professor Heo Chang-hoon presenting at the Merz Xeomin press conference"Improving toxin quality and strengthening management change perceptions Merz's botulinum toxin Xeomin has been upgraded to room-temperature storage. It emphasized quality as the only room-temperature storage product with the highest purity among botulinum toxin drugs on the market in Korea. Merz held a press conference at the Grand InterContinental Seoul Parnas Hotel in Gangnam-gu, Seoul on the 9th to commemorate the Xeomin room temperature storage (1 to 25 degrees Celsius). Launched in 2011, Xeomin has recently changed its license for storage temperatures. Unlike other botulinum toxin preparations that require refrigeration at 2 to 8 degrees, Xeomin can be stored at 9 to 25 degrees Celsius. It is the only toxin product on the domestic market that is stored at room temperature. In order for biological agents such as botulinum toxin to be licensed for upper marriage storage, consistent effectiveness, and stability must be demonstrated at 1 to 25 degrees. As a result of the experiment, Xeomin confirmed that biological activity and human serum albumin content remained constant for 36 months under conditions of 25 degrees Celsius and 60% humidity. Director Park Je-young (Oracle Dermatology in Apgujeong), who served as the speaker of the meeting, said, "Xeomin has already been allowed to be stored at room temperature in the U.S. and Europe. This means that there is a low risk of decomposition and deterioration of products that may occur due to temperature changes during transportation or distribution," he explained. As a result, Xeomin is the only botulinum toxin preparation that removes complex proteins and can be stored at room temperature at the same time. It minimized the risk of developing resistance by leaving only neurotoxin, an active substance, and proved high stability by storing it at room temperature. Heo Chang-hoon, a dermatologist at Seoul National University Bundang Hospital, said, "Botulinum toxin is determined based on ▲ the purity of neurotoxin ▲ consistency of effect expression ▲ stability during distribution and storage." In particular, toxin preparations are often not consistently refrigerated in storage and movement, and Xeomin has achieved the desire of all medical staff and pharmaceutical companies to store them at room temperature, he added. Yoo Soo-yeon, CEO of Merz, said, "This permit can save the use of energy essential for refrigeration, which is in line with the ESG management pursued by Merz."
Company
80 billion won worth of Anticonvulsant Market
by
Nho, Byung Chul
Feb 09, 2023 05:49am
In the 80 billion Anticonvulsant market, Topiramate-based treatments form 30 billion units, leading the market. The epilepsy drug consists of about 10 components, including Topiramate, Lamotrigine, sodium Valproate, Oxcarbazepine, and Perampanel. According to the drug distribution performance data, as of last year, the performance of Lamotrigine, sodium valproate, Oxcarbazepine, and Perampanel drugs was 14.9 billion won, 10.4 billion won, 7.6 billion won, and 4.5 billion won, respectively. It is also notable that the rest of the formulations, excluding topiramate, show an annual growth rate of around 100 million won to 300 million won. About 10 products of Topiramate formulations have been released, forming the largest number of epilepsy drugs. Total sales in 2018, 2019, and 2020 were 23.2 billion won, 25.7 billion won, and 28.9 billion won, with the highest growth rate. The leading product of topiramate ingredients was the Janssen Topamax Sprinkle capsule, which generated about 10 billion won in sales last year. SK Chemicals Qudexy and Huons Ceti followed with 2.2 billion won and 2.1 billion won. GSK Lamicta, the No. 1 product of Lamotrigine ingredients, maintained its appearance of 11.9 billion won in 2021. It has the highest performance based on a single product of epilepsy drugs. Lamostal and Bukwang Lamotigine ranked second and third in the same ingredient, which recorded 800 million won 600 million won in performance. Myungin Camazepine and Novartis Tegretol Korea form an appearance of 2.9 billion won and 2.4 billion won. Perampanel-based product Eisai Korea Fycompa's 2021 performance is 4.5 billion won, while Handok Sentil is moving within 900-1 billion won for five years. According to academia, the prevalence of epilepsy is about 4 to 10 per 1,000 people, and it is known that 20 to 70 people per 100,000 people occur newly every year, especially in childhood (under 9) and old age (over 60). Genetic defects cannot be excluded as the cause of epilepsy, but it is a general classification criterion to classify it into structure, metabolism, and unknown cause. It is a case of seizures due to acquired diseases such as stroke, brain damage, and infection due to structural and metabolic causes, and can come from brain nerve cell stimulation due to hypoglycemia, uremia, withdrawal of alcohol, and sleep deprivation. Most likely causes include cerebrovascular disease, encephalitis, hippocampus sclerosis, cerebral palsy, brain tumors, vascular deformities, and degenerative diseases, but more than half of the causes are unknown. Looking at the guidelines for treatments of the Korean Epidemiology Association, epilepsy can be improved with drug treatment, and 60-70% of patients can control seizures with treatments. Since drug treatment should be maintained for a long period of at least two years, it is important to choose a drug that suits each patient's condition.
Company
Olumiant may land to treat alopecia areata in KOR this year
by
Eo, Yun-Ho
Feb 09, 2023 05:49am
The JAK inhibitor ‘Olumiant’ may be prescribed to treat hair loss in Korea within the year. According to industry sources, the Ministry of Food and Drug Safety is conducting a review on expanding the indication of Lilly Korea’s JAK inhibitor Olumiant (baricitinib) to severe alopecia areata in Korea. The company may receive the final marketing authorization for the indication in the first half of the year at the earliest. Olumiant was approved for the alopecia areata indication in the US and Japan in June last year and received a recommendation for its use in the EU as well. With the approvals, the drug is quickly making its way into the global market. Olumiant selectively and reversibly inhibits JAK1 and JAK2 to reduce the expression of inflammatory cytokines and demonstrates an overall anti-inflammatory effect. It was first approved as a treatment for rheumatoid arthritis, then expanded its indication to atopic dermatitis in some countries including Korea. In the US, Olumiant is also prescribed to treat hospitalized COVID-19 patients. Alopecia areata is also an autoimmune disorder that causes the body to attack its hair follicles, resulting in hair falling out. In addition to scalp hair, eyebrows, and eyelashes can also fall out. The efficacy of Olumiant was demonstrated through the BRAVE-AA1 and BRAVE-AA2 trials that were conducted on patients with severe alopecia areata. The two trials evaluated the safety and efficacy of Olumiant in 1,300 patients compared with the placebo. In the AA1 trial, 22% of the 184 patients in the Olumiant 2mg arm and 35% of the 281 patients in the Olumiant 4mg arm showed an appropriate level of scalp hair coverage and achieved a Severity of Alopecia Tool (SALT) score of 20 or less. The rate was only 5.3% in the placebo arm. The higher the SALT score, the more severe the degree of hair loss is considered to be. 31% and 35% improvements in eyebrow and eyelash coverage were also observed in the Olumiant 2mg and 4mg arm, respectively. In the AA2 trial, 17% of the Olumiant 2mg arm and 32% of the Olumiang 4mg arm achieved a SALT score of 20 or less, which was a significantly higher proportion than the 2.6% in the placebo arm. Reimbursement for Olumiant was extended to atopic dermatitis in May last year after being first listed for rheumatoid arthritis in 2018.
Company
Entresto’s sales exceeded KRW 40 billion last year
by
Feb 08, 2023 05:53am
Pic of Entresto Sales of Novartis Korea’s chronic heart failure treatment ‘Entresto’ has exceeded KRW 40 billion 6 years into its release. According to market research institution UBIST on the 7th, Entresto’s outpatient prescription sales had recorded KRW 40.6 billion last year. This is a 26% increase from the KRW 32.3 billion it had recorded the previous year. Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that combines the angiotensin receptor blocker (ARB) 'valsartan' and neprilysin inhibitor 'sacubitril.' The drug may be used as an alternative to an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor in patients with left ventricular (LV) dysfunction as an alternative to other heart failure treatments. Entresto received marketing authorization in April 2016 and the drug was officially launched with reimbursement in October 2017. Although the drug recorded KRW 6.3 billion in its first year of release in 2018, its sales surged to KRW 15 billion in 2019, KRW 23.5 billion in 2020, then exceeded KRW 30 billion and recorded KRW 32.3 billion in 2021. Data: UBIST The drug’s quarterly sales first exceeded KRW 10 billion for the first time last year. Last year, Entresto raised sales of KRW 9.1 billion in Q1, then KRW 9.6 billion in Q2, then KRW 10.5 billion in Q3. In Q4, its sales continued to rise to record KRW 11.4 billion in Q4 last year. Entresto made explosive growth demonstrating its superior efficacy in heart failure with reduced ejection fraction (HFrEF). Entresto replaced the ACE or ARB inhibitors that had been mainly used in these patients. In HFpEF, no suitable treatment exists other than Entresto. Entresto may be used in patients with a left ventricular ejection fraction of 40% or higher to 60% (below normal level). Based on the evidence, the Korean Society of Heart Failure (KSHF) recommended Entresto as a priority treatment in HFrEF, and as a Class IIa, Level of Evidence B in heart failure with mildly reduced EF and heart failure with preserved ejection fraction in the newly revised clinical practice guidelines last year. Recently, Novartis released large-scale real-world trial data on Entresto that was conducted on Korean patients, increasing evidence on the efficacy and safety of the drug. Results of the study that was conducted on a total of 600 patients from 2017 to 2019 showed that patients first started treatment with the initial 50-100 mg bid dose and maintained or stably increased the dose for 12 and reached target dose. The trial results addressed the concerns on how the target dose of Entresto was difficult to administer due to concerns over hypotension. Of the total patients, about 40% maintained their dose of Entresto, and 42% stably increased their dose. SGLT-2 inhibitors, which were previously used as diabetes drugs, had expanded their scope to treating heart failure. Although new drugs with new mechanisms of action have also been introduced to the market, Entresto's growth is expected to continue for the time being as newly introduced drugs have a different mechanism of action, and various attempts at its combined use with other class drugs are expected to be made. Domestic companies have been continuing their attempts to challenge Entresto that had emerged as a blockbuster drug. Domestic pharmaceutical companies, starting with Hanmi Pharmaceutical, followed by Chong Kun Dang, Samjin Pharm, Hana Pharm, and Ahn-Gook Pharmaceutical, filed suits to avoid all four patents related on Entresto. Last year, Hanmi Pharmaceutical was the first to succeed in avoiding all 4 patents related to Entresto. Since then, 9 more companies have succeeded in avoiding the patents. In other words, the generic companies have all won the first trial. Novartis appealed to the results of the first trial, and the second trial is currently in progress.
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