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- 2025-12-21 05:14:24
- Policy
- Drugs with 'amlodipine' formulation get pediatric indication
- by Lee, Hye-Kyung Apr 15, 2024 06:06am
- Now, the 109 items of 'amlodipine besylate' monotherapy, which is used for the treatment of hypertension and angina, can be used for treating pediatric patients with hypertension. The Ministry of Food and Drug Safety (MFDS) ordered the change of approval conditions for 'amlodipine besylate monotherapy (doses 5mg, 10mg, tab)'. The change of approval conditions will be in effect starting May 2nd. According to the details of the change of approval conditions, the previous precaution, 'Safety and efficacy have not been established in pediatric patients,' has been revised to 'This medication (2.5 mg-5 mg per day) has a blood pressure-lowering effect in patients aged 6-17 years.' However, the precaution will note that the drug’s effectiveness for hypertension in patients under the age of six has not been established. The Ministry of Food and Drug Safety (MFDS) ordered the change of approval conditions for According to the pediatric clinical trial data, 62 pediatric patients aged 6-17 years with hypertension received doses ranging from 1.25 mg to 20 mg daily. Pharmacokinetic parameters such as clearance and volume of distribution, when adjusted for body weight, were similar to those in adults. The clinical trial involved 268 pediatric patients aged 6-17 years with hypertension who were randomly assigned to receive either 2.5 mg or 5 mg of amlodipine once daily for the first four weeks. Then, the patients were randomly assigned to groups of the same amlodipine doses or the placebo group for the following four weeks. All patients who received amlodipine 2.5 mg or 5 mg showed a significant reduction in systolic blood pressure compared to placebo after eight weeks. Safety and efficacy studies in pediatric patients beyond eight weeks have not been conducted, and the long-term effects of amlodipine on growth and development, myocardial growth, and vascular smooth muscle in pediatric patients have not been studied. Furthermore, the drug was previously limited to 'pregnant women or women who may be pregnant' but now includes 'lactating women.' In the meantime, Ahngook Pharm is the first company in South Korea to receive approval for a formulation containing amlodipine for the treatment of pediatric hypertension. Last June, Ahngook Pharm received the MFDS approval for 'Levotension Tab' for the treatment of pediatric patients with hypertension between the ages of six and seventeen.
- Policy
- Reimb price of Forxiga generics fluctuates amid changes
- by Lee, Tak-Sun Apr 12, 2024 05:41am
- AstraZeneca How the changes in reimbursement status of Forxiga (dapagliflozin propanediol monohydrate) generics will affect market competition is gaining industry-wide attention. The generic versions, which had been introduced to the market in April last year, are facing price changes due to changes in their reimbursement status. The premium pricing granted to first generics and Korea Innovative Pharmaceutical Companies ended on the 8th, and Ilsung Pharmaceuticals' reimbursement was suspended on the 9th. Pharmaceutical companies are eyeing how these reimbursement changes will impact the generic market ahead of the market withdrawal of the original Forxiga. According to industry sources on the 11th, the premium pricing granted to dapagliflozin propanediol monohydrate 5mg and 10mg generics ended on the 4th. In the case of the 5mg dose, prices of all 7 generic drugs that were granted non-innovative company first generic premium pricing (previously priced at KRW 291) and all 3 generic drugs that were granted innovative company first generic premium pricing (previously priced at KRW 333) will be reduced to KRW 262 with the end of the 1 year premium pricing period. As a result, the prices of all 21 products on the reimbursement list are now the same, which means that companies will no longer be able to use the higher drug price as a weapon to increase promotion costs. In the case of the 5mg product, the competition is between the generic drugs as the original Forxiga 5mg (AZ) was added to the reimbursement list in 2014 and then removed in 2018. In addition, Ilsung Pharmaceuticals' Dapalon Tab 5mg was suspended from reimbursement on Sept. 9. The MFDS decided to cancel its license after it was revealed that the company sold the product before the original Forxiga’s patent expiry last year. Daewoong Pharmaceutical, which had sold the original Forxiga from March 2018 to January, also entered the market with its own generic on the 1st. Through a transfer and assignment, the company’s Forxilo 5mg was added to the reimbursement list. The premium pricing granted to 10mg products, which are much more competitive, has also ended. The price of 18 non-innovative company first generics (previously KRW 437) and 5 innovative company first generics (previously 499 won) will be lowered to KRW 393. As a result, the generic price of the 10mg products will be split into two: KRW 393 for drugs that met both requirements and KRW 334 for those that met only one requirement. With the end of the premium pricing granted to generic drugs, their price gap with the original Forxiga 10mg, which is maintained at KRW 734 through a stay of execution of an administrative disposition order, has widened. However, Forxiga 10mg will be withdrawn from the domestic market in the second half of the year. Before that, it will reportedly transfer indications for chronic heart failure and chronic renal failure, including diabetes, to HK Inno.N’s product. Currently, the generic product only has a diabetes indication. Until its market withdrawal, AstraZeneca wants to maintain the domestic price of the drug, which is contingent on the results of the ongoing price-volume agreement negotiations with the National Health Insurance Service. Reimbursement for Ilsung Pharmaceuticals' Dapalon Tab 10mg was also suspended as of the 9th. On the other hand, the premium pricing of 12 salt-modified drugs will remain intact for 2 years (until April 8, 2026) due to having three or fewer generic companies manufacturing the same. This puts generic companies at a disadvantage in terms of spending expenditures. The sharp changes in the reimbursement landscape for Forxiga generics mark the start of a new round of competition in the market. Meanwhile, Forxiga generics have generated about KRW 30 billion in outpatient prescriptions (UBIST) in the 9 months since it entered the market in April last year.
- Policy
- Clopidogrel recall due to 1 CMO…’no issue escalation’
- by Lee, Hye-Kyung Apr 11, 2024 05:44am
- The issue that stirred up the clopidogrel recall that had been ongoing since March was found to have been caused by a single contract manufacturer, making the concern of it escalating to a series of recalls unlikely. Starting with Daewoong Bio's 'Clovons Tab' on March 17, the Ministry of Food and Drug Safety recalled a total of 29 items from 27 companies by April 2. The MFDS’s reason for the recall is 'exceeding the standard for miscellaneous related impurities during post-marketing stability tests'. In the case of marketed drugs, stability tests are required to be conducted annually for all dosage forms, on at least one manufacturing lot each per packaging type that contains the same substance as the marketed product. However, if the items manufactured by the contract manufacturing organization (CMO) are identical to the items manufactured by the consignor in accordance with the 'Standards for the Manufacturing and Quality Control of Finished Pharmaceutical Products' in terms of raw materials, quantity, manufacturing method, manufacturing facilities, and packaging materials, the consignor may submit the CMO’s stability test data. Regarding the clopidogrel situation, an MFDS official said, "It is not a problem of impurities in the clopidogrel ingredient itself, which was the issue during the nitrosamine impurity issue. The items that have been announced for recall so far were all manufactured by a single CMO on consignment." "There is a deadline for submitting post-marketing stability testing data, and the recall was triggered by a discovery of an impurity in the purity test that was conducted within the deadline.” The 29 items of the 27 companies that have been recalled were manufactured by Daewoong Bio, and most of them were manufactured in 2021 and 2022, therefore their expiration date has passed or is about a year away. In particular, among the 27 companies, ▲Icure, ▲Ildong Pharmaceutical, ▲Pharmgen Science, ▲Intro BioPharma, ▲Ilsung Pharmaceuticals, ▲Kyongbo Pharmaceutical, ▲Hanlim Pharm, ▲Kunil Pharm, ▲Kolong Pharma, ▲Reyon Pharm, ▲Seoul Pharma, ▲Eden Pharma, ▲Ahngook New Pharm, ▲Yuyu Pharma, ▲ Hankook Korus Pharm changed to in-house manufacturing or switched contract manufacturers. However, as the MFDS's recall announcement did not disclose the companies that had previously signed CMO contracts with Daewoong Bio, concerns arose on how the impurity crisis may continue to the more recent products manufactured and sold by companies that had changed CMOs. In this regard, an MFDS official said, "If you search the current information, there are 13 consignors of Daewoong Bio. Some of the consignors that were entrusted manufacturing in the past have changed to in-house manufacturing or other CMOs.” "Currently, items other than those listed in Daewoong Bio's batch information are produced by on their own or by other manufacturers. "In the case of clopidogrel, there are no impurities in the clopidogrel ingredient itself, unlike the nitrosamine impurity issue.
- Policy
- 4th-generation, 3 chamber IV nutrition receives reimb
- by Lee, Tak-Sun Apr 11, 2024 05:44am
- JW Pharmaceutical’s fourth-generation 3 chamber nutrient fluid was officially launched in January. Fourth-generation 3 chamber Total Parenteral Nutrition (TPN), with enhanced amino acids contents, are being introduced into the market. Following the reimbursement listing of related products by Baxter and JW Pharmaceutical, HK inno.N and Fresenius Kabi have joined the competition. Companies that competed previously in the third-generation market are now entering fourth-generation market. The 3-chamber nutrient fluid is an IV infusion product that contains 3-chamber bags for amino acids, lipids, and sugars. Recent fourth-generation products contain higher amino acid contents. On April 1, HK inno.N’s 'Omapplusone Inj' was listed for reimbursement at KRW 50,246. Last year, Olimel N12E Inj was listed as a third-generation product for reimbursement for the first time. From October to November of last year, four doses of Olimel N12E Inj (650, 1000, 1500, 2000 mL) were launched with reimbursement coverage. Its reimbursement ceiling prices are KRW 29,746 for the 650 mL product and KRW 55,202 for the 2000 mL product. JW Pharmaceutical’s Winuf A Plus Inj and Winuf A Plus Peri Inj entered the market as well. From November to December of last year, two Winuf A Plus Inj (1090, 1438 mL) products and two Winuf A Plus Peri Inj (1089, 1452 mL) products were listed for reimbursement. The minimum price was set at KRW 40,197 for Winuf A Plus Inj (1090 mL), and the maximum price was set at KRW 45,679 for (1452 mL) This year, HK inno.N reimbursement listed their products in February and this month. Seven products, including three Omapplusone Inj (986ml, 1477ml, 1970 mL) and four Omapplusone Peri Inj (724, 952, 1448, 1904 mL), were reimbursement listed. The company’s approach seems to offer a wide range of doses than its competitors. The minimum price was set at KRW 31,285 for Omapplusone Peri Inj (724 mL), and the maximum price was set at KRW 54,153 for Omapplusone Inj (1970 mL). Last January, Fresenius Kabi, a foreign pharmaceutical company, secured a listing of Ntense EF Inj (1012 mL) at KRW 40,197. It was reported that the company is currently in the process of pricing Ntense Inj. These four pharmaceutical companies compete intensely in the third-generation nutrition fluids market. In order of market share, JW Pharmaceutical, Fresenius Kabi, HK inno.N, and Baxter dominate the market, which is approximately KRW 150 billion. As pharmaceutical companies release their fourth-generation products into the market, tough competition for securing a place in the market is anticipated.
- Policy
- Approval of Beyfortus imminent in Korea
- by Lee, Hye-Kyung Apr 09, 2024 05:50am
- Beyfortus (nirsevimab), a long-acting antibody designed to prevent respiratory syncytial virus (RSV) in infants that was jointly developed by Sanofi and AstraZeneca, is soon to receive marketing authorization in Korea. According to the minutes of the Central Pharmaceutical Affairs Council meeting held on March 6, which was released by the Ministry of Food and Drug Safety on the 5th, the members discussed the "feasibility of granting marketing authorization based on the submitted data, which includes bridging data” for an RSV vaccine and concluded that it was “feasible” Although the name of the product was not disclosed in the minutes, the discussed item appears to be Beyfortus, which applied for approval last year, based on how the unnamed drug 'can be used in healthy children', and submitted data on clinical trials conducted on newborns, and dosages divided into weight groups. Beyfortus is approved and used in the U.S. and Europe for the prevention of RSV lower respiratory tract disease in neonates and newborns born during the RSV season or will experience the first RSV season, and in infants up to 24 months of age who are susceptible to severe RSV disease during their second RSV season. RSV is a contagious virus that affects the lungs and breathing when infected and is a potentially life-threatening and serious condition primarily in young infants, people with certain chronic medical conditions, and the elderly. It is estimated that RSV kills approximately 102,000 children worldwide each year. The CPAC discussed the feasibility of the drug’s approval with the included bridging data, and one member said, "Although the number of Korean subjects is small, the characteristics of the drug and the disease do not appear to be sensitive to ethnicity. We believe that it can be authorized.” Existing treatments had limitations in preventing RSV disease in high-risk populations, but this drug could be used in healthy children, potentially expanding RSV prevention options. However, it was also mentioned that post-marketing surveillance (second review) would be required as it is a new drug. One committee member said, "The pharmacokinetics, ADA, and other evaluation indices presented from post-marketing clinical trials in 20 infants have limitations due to difficulties in blood collection and data interpretation." Another said that future safety monitoring and continuous follow-up on the RSV epidemic in Korea would also be necessary. Regarding this, the MFDS said, "There are cases where deliberations had been made using bridging data. We wanted to discuss the feasibility of its approval and ways to supplement the lack of data. The existing RSV drug was exempted from submitting bridging data because it was an orphan drug." Regarding the dosage, the CPAC said that the dosage of the existing product is 15mg/kg, this drug is administered at a fixed dose by weight group (less than 5 kg / more than 5 kg). Therefore, although there may be a difference in exposure for those on the borderline of weight, it would not be a problem for ease of use. The CPAC chairman said, “Our members concluded that when considering the mechanism of action of how the drug binds to the virus, the drug is not expected to be sensitive to ethnic factors, and the actual data also proved as such. Based on the data confirming that the binding site of the virus has not mutated or developed resistance, and the unmet medical need, the drug’s marketing authorization is deemed feasible.” If and when Beyfortus is approved, Sanofi will be responsible for its domestic marketing and sales.
- Policy
- 'Need patient engagement for reimb of high-priced drugs'
- by Lee, Tak-Sun Apr 08, 2024 05:46am
- A study has shown that there is a need for a formal process for patient organizations and patients to participate in discussions for the reimbursement of high-priced drugs in Korea. With the reimbursement of high-priced drugs rising as a social issue and patient organizations and others raising concerns, the opinion has risen on the need for an official window for the patients’ participation. These findings were presented in the Health Insurance Review and Assessment Service's own 'Comparative Research on the Reimbursement Management Systems for High-Priced Drugs in Korea and Abroad' (Principal Investigator: Associate Researcher Yoo-Jung Kim). The results of the study were released on HIRA's website on April 4. After reviewing the cases of high-priced drugs Spinraza, Hemlibra, Enhertu, and Jakavi that arose as issues through press conferences or public petitions by patients or patient organizations, and explained the need for an official window that allows patient participation. In the final report, the research team wrote, "While domestic patients are represented by members of the Drug Reimbursement Evaluation Committee, there is no formal process for patient organizations to participate in the decision-making process for drugs. There needs to be a formal administrative process for domestic patient organizations and patients to formally submit their opinions and participate in the decision-making process. "Until now, Korean patient organizations have made demands in a one-time, informal manner in the form of complaints or petitions. Due to the large amount of pressure the media puts on the government to accept such demands, and the fact that the Health Insurance Review and Assessment Service responds to complaints on a case-by-case basis rather than through a formal process, the one-time complaints increase the workload and stress of HIRA employees." The researchers added, “The lack of a formal process means that the opinions of all patient organizations cannot be objectively and fairly reflected, and only the demands of some patient organizations may be expressed.” Other countries had formal processes for patient organizations’ input. The UK, France, Germany, Canada, Australia, and Taiwan all had such processes, leaving only Italy and South Korea without. Excerpt from the As policy recommendations for managing high-cost drugs, the researchers suggested the need to internalize the price-volume agreement system, evaluate the effectiveness of high-priced drugs, and expand the outcome-based risk-sharing system in the short term. In particular, this should be preceded by the establishment of a high-priced drug follow-up management system. In addition, the research team added that a pharmacoeconomic evaluation exemption system needs to be changed into a pharmacoeconomic evaluation deferral system, and the existing PE exemption drugs should also undergo reevaluations. In addition, improving the pre-approval system was also cited as a short-term improvement task. Based on the research results, HIRA has recently started implementing the improvements. In the long term, the team emphasized that early access to rare diseases and anticancer drugs should be improved through a separate fund outside of health insurance finances to generate evidence to confirm the effectiveness and safety of new drugs.
- Policy
- Recalls of antiplatelet drugs containing 'clopidogrel'…
- by Lee, Hye-Kyung Apr 05, 2024 05:44am
- The recall of the products due to exceeding safety standards for miscellaneous impurities in safety tests for the antiplatelet drugs containing the ingredient 'clopidogrel' is expanding. The Ministry of Food and Drug Safety (MFDS) reported that a total of 29 items have been recalled until April 2, starting with Daewoong Bio’s 'Clovons Tab' on March 17. Products containing clopidogrel bisulfate and clopidogrel sulfate are recalled. As these products are primarily contract manufacturing items, recall measures are rising. Daewoong Bio manufacturing plant items, including Korea Syntex Pharmaceutical, Daewoo Pharm, Mirae Pharm, Rp Bio, Spc Pharm, Kwang Dong Pharmaceutical, Bukwang Pharm, and Guju Pharm, are recalled. The first instances of exceeding impurities standards were detected in 13 items of Daewoong Bio. Among these, the Daewoong Bio manufacturing plant items, including Korea Syntex Pharmaceutical, Daewoo Pharm, Mirae Pharm, Rp Bio, Spc Pharm, Kwang Dong Pharmaceutical, Bukwang Pharm, and Guju Pharm, are recalled. Hanlim Pharm and Kyongbo Pharmaceutical have recently switched their CMO partner to Youngil Pharm, but the recalled products were confirmed to be those previously manufactured by Daewoong Bio. Some CMO companies announced in a public statement that “We received an official letter from Daewoong Bio, which is responsible for contract manufacturing the whole process of clopidogrel, to voluntarily withdraw the product.” They added, “The reason for the voluntary recall is that products exceeded impurities standards in the safety test.” It appears that the products that exceeded impurities standards were confirmed during the safety test for long-term storage. Testing the long-term storage of medicines is a safety test for drugs with a maximum shelf life of three years. Medicines undergoing the test are stored for at least six months before the test. The MFDS sees that the drugs had no issues when manufactured, but impurities occurred during the long-term storage process. According to UBIST, a market research agency, the outpatient prescription amount for the market of antiplatelet drugs containing clopidogrel was KRW 532.7, up 7.9% from KRW 493.5 in 2022. The market of antiplatelet drugs containing clopidogrel topped KRW 400 billion in 2019. Despite the ongoing COVID-19 pandemic, this market maintained steady growth of around 7%. The drugs with clopidogrel ingredients are used to improve symptoms of atherosclerosis in patients with ischemic stroke and myocardial infarction. It is also prescribed as a maintenance therapy following stent surgeries.
- Policy
- Orphan drug Ilaris receives conditional pass for reimb again
- by Lee, Hye-Kyung Apr 05, 2024 05:43am
- Although the government restarted reimbursement discussions for Novartis Korea's orphan drug Ilaris Inj (canakinumab) after 2 months, the results were the same. According to the "Results of the 4th 2024 Drug Reimbursement Review Committee Deliberations," which was released on the 4th by the Health Insurance Review and Assessment Service, Ilaris was deemed adequate for reimbursement for the following indications: ▲Cryopyrin-Associated Periodic Syndromes (CAPS), Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), ▲Familial Mediterranean Fever (FMF), and ▲ Systemic Juvenile Idiopathic Arthritis (SJIA). However, the approval came with a condition. Further evidence for the three indications - CAPS, TRAPS, and FMF - must be submitted for the reimbursed use of the drug. At the DREC meeting in February, Ilaris was deemed adequate for reimbursement subject to submission of further evidence, but Novartis filed an appeal, putting the decision on hold. Novartis then requested a reevaluation and received another DREC review after 2 months, but the results remained unchanged. Ilaris, which was deemed adequate for reimbursement along with Enhertu Inj, is a treatment for a rare disease called periodic fever syndrome, which affects only 13 patients in Korea. It is a drug that HIRA President Jung-Gu Kang said he would make efforts for prompt reimbursement during the National Assembly audit in October last year. Ilaris is the only IL-1 inhibitor recommended by international guidelines for the treatment of hereditary periodic fever syndrome and is approved by both the U.S. FDA and the European EMA. Based on the efficacy and safety of the drug confirmed through clinical studies, it is being reimbursed in a total of 30 countries. However, it is facing difficulties in receiving reimbursement approval in Korea. Novartis made two previous attempts for Ilaris’s reimbursement in 2017 and 2022 but failed both attempts. This is its third attempt. Ilaris is also an expensive drug, costing KRW 8 million to KRW 100 million per year for once every 8-week dose. If Novartis accepts DREC’s decision this time, the reimbursement process for Ilaris will progress rapidly, but if it doesn't, its reimbursement will again be at a standstill. Meanwhile, ‘Orkedia Tab 1mg, 2mg, (Orkedia Tab),’ Kyowa Kirin Korea’s treatment of secondary hyperparathyroidism in patients on maintenance dialysis was deemed adequate for reimbursement by DREC at the same meeting. In the case of Santen Pharm Korea’s ‘Rhopressa Ophthalmic Soln. 0.02% (Netarsudil Mesylate),’ which is a treatment for open-angle glaucoma and ocular hypertension, the drug was deemed adequate for reimbursement if the company accepted a price lower than the evaluated price. Takeda Pharmaceutical Korea’s ovarian cancer treatment ‘Zejula Cap. 100mg (niraparib tosylate monohydrate)’ was reviewed for RSA coverage expansion, but DREC determined its adequacy to be unclear.
- Policy
- HIRA in final stages of preparing expense report survey
- by Lee, Tak-Sun Apr 05, 2024 05:43am
- The Health Insurance Review and Assessment Service is busy preparing a survey and public disclosure of the expenditure reports on economic benefits pharmaceutical companies and medical device companies provided to doctors and pharmacists. As the data submitted by pharmaceutical companies through the survey will be subject to public disclosure, HIRA is also planning to build a system for relevant data collection. However, it plans to receive the data through a temporary system this year and open a formal system next year. According to industry sources on the 3rd, HIRA informed pharmaceutical organizations about the survey on expenditure reports. The survey will be conducted for 2 months from June to July like in the past year. In June, drug wholesalers, and in July, drug licensees, importers, and promoters must submit their previous expenditure reports to HIRA's expenditure report management system, Korea Patient Safety Reporting (KOPS). This year, consignment sales organizations (CSOs), which are entrusted with the sales promotion duties, will also be subject to submit data. CSOs are also required to prepare their own expenditure reports. However, HIRA added that it is advisable for the drug suppliers to manage and supervise the expenditure reports prepared by CSOs. The survey will cover general information such as company information and expenditure report operation status, as well as the 1-year expenditure report prepared from January to December 2023. The expenditure report includes the provision of samples, support for conferences, support for clinical trials, product presentations, post-marketing surveys, and discounts based on payment terms. In last year's survey, pharmaceutical companies uploaded the data in an Excel format, but this year's survey will be conducted in two ways: companies can directly enter the information into the temporary system or upload the data in an Excel format. The results of the survey will be posted on the MOHW website in December, just like last year. Separately, the expenditure reports submitted by pharmaceutical companies in December through KOPS will be made public for 5 years. The disclosed data will be replaced with the data the companies submitted for the expenditure report survey. HIRA plans to database the submitted data and post it according to the open principle. Last month, the Ministry of Health and Welfare announced the 'Operational Guidelines for Public Disclosure of Information,' and explained that the names of recipients, including those of the medical practitioners whose personal information may be leaked, and clinical trial information that contains the companies’ business strategies will be de-identified, then disclosed. HIRA has additionally begun hiring personnel to support the disclosure of expenditure reports and surveys. It announced on Jan. 1 that it would hire 12 people for the service through an emergency bid announcement on 'management staff dispatch service'. A HIRA official said, "This year, we plan to temporarily build an expenditure report management system, and open an official system next year. We plan to make the public disclosure in December, and we will disclose the information after discussing the scope of the disclosure and databasing the data submitted by companies."
- Policy
- Trajenta generics enter reimbursement pricing…
- by Lee, Tak-Sun Apr 05, 2024 05:43am
- DPP-4 diabetes drug Trajenta tab. The generic version of Trajenta (linagliptin), a DPP-4 inhibitor class, has applied for reimbursement pricing ahead of its launch in June. This year, generic market is drawing attention to Trajenta. With the exclusive rights for Trajenta is set to expire, after Forxiga and Januvia last year, the diabetes market is expected to see new competition this year. According to industry reports on the 4th, Trajenta generics applied for reimbursement pricing. Subsequently, the Health Insurance Review and Assessment Service (HIRA) started the pricing process. It is expected that Trajenta generics would be listed on June 9 when the substance patent of the original drug expires. Generic companies have confirmed the release date for June after winning the dispute over Trajenta’s unregistered substance patents. In January, the Intellectual Property Trial and Appeal Board (IPTAB) gave a verdict validating the claims on patent challenges by five generic companies, including Genuonesciences, for invalidating three counts of Boehringer Ingelheim’s use patents for Trajenta. Consequently, when the product patent expires on June 8, the generic companies are expected to enter the market based on the verdict. The DPP4 inhibitor formulation patent, which is set to expire in 2027, remains on the patent list of the Ministry of Food and Drug Safety (MFDS). However, most of the pharmaceutical companies have avoided this patent type. 60 Trajenta monotherapy generics and 204 Trajenta-duo (linagliptin+metformin) combination therapy generics have received approval. Most known domestic pharmaceutical companies are set to enter the market. Notably, generic companies have developed SR tablets unavailable in Trajenta-duo and have completed approval. According to UBIST last year, Trajenta accumulated an outpatient prescription amount of KRW 61.3 billion and Trajenta-duo accumulated an outpatient prescription amount of KRW 62.1 billion. Together, those two generated a KRW 120 billion-worth market. The market size is comparable to Januvia (KRW 34.9 billion), Janumet XR (KRW 41.1 billion), and the Janumet series. Following the expiration of Januvia's patent last year, over 200 products entered the market, and similar interests are observed for Trajenta generics as well. However, Januvia generics occupied the market in advance in September. As many pharmaceutical companies intensify their sales efforts to dominate the market, it is anticipated that they may not be able to put their efforts into Trajenta generics belonging to the same class as Januvia.
