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- 2025-12-23 23:29:32
- Policy
- AZ vaccine for 780,000 people will be inoculated
- by Lee, Tak-Sun Feb 18, 2021 06:28am
- AstraZeneca's COVID-19 vaccine, which starts vaccination on the 26th, received lot release from the MFDS. As a result, it is delivered from the factory and administered at each inoculation site. The lot-released vaccine is expected to be effective until June, and the KCDA plans to complete the vaccination until May. On the 17th, the MFDS approved lot release for 5 serial numbers of AstraZeneca Korea's COVID-19 vaccine. The total amount is about 1,574,000 doses, and considering that the vaccine is given twice, it is for 787,000 people in total. All of the contracts between AstraZeneca and the government, which will be inoculated in the first quarter, have been lot released. It is manufactured by SK Bioscience in Korea. The expiration date of the product released this time for lot release is mid-June. The KCDA has a policy to complete the second vaccination by May to the targets for the amount of vaccination, so the short expiration date is not expected to be a problem. The KCDA plans to inoculate this vaccine to ▲geriatric hospitals and nursing facility residents and workers (approximately 272,000 people) ▲high-risk medical institution workers (approximately 362,000 people) ▲COVID-19 first responders (approximately 78,000 people). However, elderly people over 65 years of age are not eligible for vaccination. Nursing hospitals and nursing facility residents and employees will receive the first vaccination from the 26th. It is expected that the first inoculation in Korea will come out of this group. The KCDA plans to complete the first vaccination of the subjects receiving the AstraZeneca vaccine in the first quarter by March, and the second vaccination by May. The interval between the first and second doses of the AstraZeneca vaccine is 4 to 12 weeks. The KCDA concluded that the second vaccination will be administered approximately 8 weeks after the first vaccination. The MFDS completed the lot release in 20 days, which usually took 2-3 months. For rapid lot release, Approval and lot release were simultaneously performed. The quantity of this lot release was produced before approval on the 10th. An official from the MFDS explained, "the quantity produced in advance to obtain permission is also included." An official from the MFDS explained, "All of the lot released quantities have been approved, and there will be additional lot releases according to the inoculation plan in the future." AstraZeneca vaccine will be supplied to 10 million people this year (excluding COVAX Facility quantities).
- Policy
- AZ vaccine, the first inoculation in Korea from the 26th
- by Kim, Jung-Ju Feb 18, 2021 06:24am
- The domestic schedule for the COVID-19 vaccination treatment made by AstraZeneca has been confirmed. The government plans to fully implement vaccinations from the 26th, but plans to accumulate and determine additional clinical information for those over 65 years old people. Inoculation of AZ vaccine to the elderly over 65 is virtually withheld. Pfizer vaccine is given first by medical staff in charge of COVID-19 treatment as early as this month to next month. Jeong Eun-Kyeong, head of the COVID-19 Vaccination Response Promotion Team, briefed today (15th) on the COVID-19 vaccination plan. According to her, starting from the 26th, those working in geriatric hospitals and nursing facilities under the age of 65 will be given AZ vaccine first. The government estimates that there are 270,000 people. For the elderly aged 65 or older, the timing of vaccination is determined through a review of the Korea Advisory Committee on Immunization Practices (KACIP) after confirming additional clinical information on vaccine efficacy. Regarding the reason for this restriction of vaccination to the elderly over 65, she said, “The safety of AZ vaccine are clear. There is a concern that the controversy on the efficacy of the elderly over 65 will lower the vaccination rate of the public and medical personnel." Pfizer's COVID-19 vaccine will be introduced at the end of this month or early March through the COVAX Facility. This product will be vaccinated by 55,000 medical staff who treat COVID-19 patients. About 350,000 workers in medical institutions such as general hospitals, as well as 78,000 first-line responders such as COVID-19 quarantine agents and epidemiological investigators are scheduled to receive the AZ vaccine from March.
- Policy
- AstraZeneca Korea earns Consignment Business Authorization
- by Lee, Tak-Sun Feb 17, 2021 05:40am
- AstraZeneca Korea earned the seventh ‘Pharmaceutical Consignment Manufacturing Business Authorization’ in South Korea due to the COVID-19 vaccine manufactured by SK Bioscience. South Korea’s Ministry of Food and Drug Safety (MFDS) reported AstraZeneca Korea has been authorized for a pharmaceutical consignment manufacturing business on Feb.10. On the same day, the South Korea’s first approved COVID-19 vaccine, ‘AstraZeneca Korea Covid-19 Vaccine injection’ was also authorized for the market. The licensor of the vaccine is AstraZeneca Korea, but it would be manufactured by SK Bioscience. Prior to receiving a pharmaceutical license, the supplier has to be licensed as a manufacturer or an importer. And an approved manufacturer in South Korea can apply for an approval on domestically marketed drug or export-only drug. A company licensed as an importer can also apply for an approval on an internationally imported drug. So far, AstraZeneca Korea was only licensed as a pharmaceutical importer in South Korea as of 2016. Up until Feb. 10, the multinational company had total of 65 licensed drugs all imported. But the company needed another business license as it manufactures the COVID-19 vaccine authorized on Feb. 10 since last July through a consignment deal signed with SK Bioscience. In 2007, MFDS newly established the Pharmaceutical Consignment Manufacturing Business Authorization for such company without a manufacturer in South Korea to receive the pharmaceutical authorization. With the license, a company can apply for an approval on an item manufactured with consignment contract. The first authorization was earned by GL Pharm Tech (CEO Wang Hunsik) in September 2008. The company owns licenses over four items including G-Soren tablet, manufactured by Richwood Trading Company. Another multinational pharmaceutical company MSD Korea (CEO Kevin Peters) also took the second authorization in 2009. MSD Korea owns licenses over three items including an anti-hypertension drug Cozaar XQ tablet, manufactured by Hanmi Pharmaceutical. Corepharm Bio, Crystal Genomics, Abbott Korea, Geongang Pharmaceutical and AstraZeneca Korea are the rest of companies with the consignment business authorization. Other companies to supply COVID-19 vaccine should be licensed in South Korea. Pfizer and Janssen have no issue as they are already licensed as an importer, and would import their vaccines. But for Novavax, who licensed out the technology to SK Bioscience, would have the South Korean company to be in charge of the approval and distribution. As for a company without a license in the country like Moderna, it would have to open a branch in South Korea to apply for the imported vaccine use authorization, or to license out for the co-promotion deal to a Korean company like Novavax.
- Policy
- Hanmi’s salt-modifying drug for Galvus, re-licensed
- by Lee, Tak-Sun Feb 17, 2021 05:39am
- Hanmi, which failed to enter the market for Vildagliptin through so-called split indications, has obtained item approval again. The MFDS approved Vildagle Tab 50mg (Vildagliptin HCl) by Hanmi on the 10th. It was licensed in January of last year, and Vildagle Tab 50mg, which was voluntarily withdrawn in July of that year. The withdrawn item is used as an adjunct to diet and exercise therapy to improve blood sugar control in type 2 diabetes patients. It was approved for four types of treatment: ▲ single therapy ▲ Metformin combination therapy ▲ Sulfonylurea and Metformin combination therapy ▲ Insulin alone or Metformin combination therapy. However, in addition to the four methods of use, this product has added sulfonylurea or metformin or thiazolidinedione co-administration. The scope of efficacy and effect has become the same as the original drug, Novartis' Galvus. Hanmi previously established a Galvus patent avoidance strategy with a product with a reduced range of usage. Insurance benefits were obtained, but the strategy needed to be revised because he lost the patent lawsuit. It was withdrawn, and re-approval was obtained with the same efficacy and effect this time. In the case of Vildagliptin, original Novartis products and products by Ahn-Gook and Hanmi are licensed. Ahn-Gook's product is Vildagliptin, the same as the original Galvus. Ahn-Gook acquired generic exclusivity through the success of the first patent challenge, and the sale of the same active ingredient was banned from August 30, 2021 to May 29, 2022, but Hanmi's salt-modifying drug for Galvus is not applied. Not only Ahn-Gook, but also Hanmi succeeded in the first patent challenge, but did not succeed in the second patent challenge. In the first (the KIPO) challenge, Galvus' material patent period was reduced by 187 days through a trial for invalidation of the extended duration, but in the second (Patent Court of Korea) challenge, only 55 days were recognized as invalid. Therefore, it must be released later than in August this year, which was originally planned for the release date. It is a burden that other generics are developing their products in line with the material patent end date of March 4, 2022. This is because it is advantageous to preoccupy the generic market by promoting product release as much as possible. Currently, Ahn-Gook and Hanmi's patent challenge was contested in the Supreme Court due to Novartis' appeal. Depending on the final outcome of the Supreme Court, the strategies of the two companies to dominate the market are expected to change.
- Policy
- Novavax vaccine needed as AZ vaccine in 65 and up postponed
- by Lee, Tak-Sun Feb 16, 2021 06:08am
- The South Korean government seems to be considering on purchasing more doses of other COVID-19 vaccine options as the government has decided to hold off on inoculating the age group over 65 with AstraZeneca’s vaccine. Originally, the 65-and-up age group was supposed to be vaccinated within the first quarter, but it has been pushed to the second quarter. And now the need for Novavax vaccine is heightened. On Feb. 15, Korea Disease Control and Prevention Agency (KDCA) disclosed the first quarter COVID-19 vaccination plan. The agency official said 272,000 occupants and inmates aged under 65 admitted to long-term nursing hospital or houses and related workers would be vaccinated first from late February, followed by 352,000 high-risk healthcare providers, 78,000 COVID-19 first responders including 119 emergency service, epidemiologist and disease control workers, and 55,000 COVID-19 patient-treating hospital workers. The government has secured AstraZeneca vaccine doses for 702,000 people and Pfizer vaccine doses for 55,000 people. The age group over 65, initially planned to be vaccinated within the first quarter, would have to wait until the second quarter due to insufficient efficacy data on AstraZeneca vaccine. About 370,000 people’s vaccination schedule would be pushed from the first to second quarter. However, the delay could cause a vaccine shortage in the second quarter as the number of eligible subjects would soar. And to prepare for the shortage, the South Korean government would need to additionally purchase more vaccine doses. Also, the government should be concerned the expected date of AstraZeneca’s vaccine efficacy confirmation in the elderly group is unknown, and predictability in vaccines developed by Janssen and Moderna is unreliable as well. Accordingly, the South Korean government is working on purchasing additional doses of Novavax vaccine with completed clinical trial in the U.K. Currently, SK Bioscience is manufacturing the Novavax vaccine under a consignment contract. The two companies have reportedly working on a licensing agreement as well. If the license-in deal gets sealed, the government plans to purchase additional doses for 20 million people from SK Bioscience. Recently, Novavax presented data on clinical trial with satisfying level of efficacy in the 65-and-up age group. The trial tested the vaccine on 15,000 people in the U.K. ranging from age 18 to 84, in which 89.3 percent of them demonstrated a successful preventive effect. 27 percent of the participants aged over 65 also showed successful rate. Meanwhile, AstraZeneca’s vaccine showed only 7.4 percent response rate in participants aged over 65, not enough to confirm the efficacy in the age group. But if the South Korean government is to procure additional doses of Novavax vaccines, the vaccination gap in the elderly age group created by AstraZeneca’s vaccine could be filled. The government sees that Novavax vaccine could be introduced in the second quarter at earliest. Director Jeong Eun-kyeong of KDCA briefed that “The South Korean government has almost reached the final stage of signing a contract for the additional Novavax vaccine doses. The vaccination for the age group over 65 would start when the COVAX-AstraZeneca vaccine, Novavax vaccine and other vaccine supply schedules are set.” Nevertheless, Novavax vaccine also has its own uncertainty. First, the company has to complete the license-out deal with SK Bioscience. Moreover, other countries’ emergency use authorization application for Novavax vaccines should be processed in March at earliest. The government’s plan to introduce the vaccine in May would be possible only if all the expected schedules proceed without an issue. Regardless of the uncertainty, Novavax vaccine has comparatively less uncertainty than other imported vaccines as they are manufactured domestically. Imported vaccines tend to have more unforeseen issues in approval date and supply. MFDS has already conducted a preliminary review on Janssen’s vaccine to be supplied in the second quarter, but the ministry has not reported any update on Moderna vaccine. And because they would be manufactured outside of South Korea, they would likely to struggle to supply the vaccines on schedule. The COVAX-Pfizer vaccine, which should have been introduced in mid February, has been delayed. Ultimately, Novavax vaccine should be secured to timely unfold the vaccination plan on the 65-and-up age group in the second quarter.
- Policy
- COVID-19 vaccine lot release to be authorized this week
- by Lee, Tak-Sun Feb 16, 2021 06:07am
- Minister of Food and Drug Safety Kim Gang-lip is explaining about the final authorization on AstraZeneca COVID-19 vaccine on Feb. 10. As a COVID-19 vaccine was authorized for the first time in South Korea, the lot release for AstraZeneca’s vaccine is expected to be granted this week. Although South Korea’s Ministry of Food and Drug Safety (MFDS) did not restrict inoculation on the age group over 65, the Korea Advisory Committee on Immunization Practices (KACIP) associated under Korea Disease Control and Prevention Agency (KDCA) is to make the final call. However, as a group of experts has decided the vaccine should also be accessible to population over 65, the advisory committee would be likely to follow the same direction. At the AstraZeneca COVID-19 vaccine authorization briefing presented on Feb. 10, the Minister of Food and Drug Safety Kim Gang-lip explained the lot release would be decided this week. Minister Kim said, “Currently, the lot release authorization procedure is ongoing. Probably the final decision would be made next week, and the authorization would be passed.” The lot release approval review would verify the quality and safety of the vaccine. And with the authorization, the vaccine would be available for the market. KDCA would finalize the AstraZeneca vaccine inoculation plan, including the details on the elderly group, by Feb. 19, and initiate the vaccination from Feb. 26. Minister Kim elaborated, “MFDS concluded the ministry could not find a reason to put a definite restriction on vaccinating the elderly group aged over 65 with AstraZeneca’s. However, warnings on the specific age group would be given at the clinical scene, and we expect KDCA to compile a reasonable guideline after surveying experts’ opinions and discussing with KACIP.” AstraZeneca’s COVID-19 vaccine was authorized for use in South Korea with a condition to provide additional data later. Minister Kim noted, “We have requested the company to submit interim and final reports on the currently ongoing clinical trial in the U.S. The trial is targeting 30,000 people, which includes about 7,500 elderly people.” The interim report should be submitted by the end of coming April.
- Policy
- Fosamax 10mg·Pletaal OD Tab has been withdrawn
- by Lee, Tak-Sun Feb 16, 2021 06:07am
- Otsuka MSD Korea's osteoporosis treatment Fosamax, and Otsuka Pharmaceutical's antiplatelet drug Pletaal OD Tab will be withdrawn from the Korean market due to poor performance. According to the MFDS on the 9th, as of the 8th, MSD Korea's Fosamax 10mg (Alendronic acid), Otsuka's Pletaal OD Tab 100mg, Pletaal OD Tab 50mg, and Pletaal Powder 20% (Cilostazol) have been withdrawn. Fosamax, original for Alendronic acid, is a bisphosphonate-based osteoporosis treatment and is widely used in Korea. Pletaal, original for Cilostazol also has a high market share in Korea for antiplatelet drugs. These items are not flagship items. Fosamax includes Fosamax 70mg, Fosamax PlusD, Fosamax Plus, and Fosamax 10mg, which has been withdrawn. Fosamax PlusD is MSD's flagship item. Fosamax PlusD recorded an outpatient prescription amount of ₩10.9 billion based on UBIST, ₩2 billion for Fosamax Plus, and ₩2.2 billion for Fosamax 70mg. There is no outpatient prescription sales of Fosamax 10mg because it is a non-reimbursement drug. Fosamax 10mg is taken once a day and Fosamax 70mg, once a week. Fosamax 70mg is highly preferred. Accordingly, MSD also focused on marketing Fosamax 70mg, and Fosamax 10mg was eventually converted to a non-reimbursement drug in 2018, and the prescription was virtually stopped in Korea. And this time with the withdrawal of the license, it was completely withdrawn from the market after entering Korea in 2008. Fosamax 10mg’s indication range is wider. This is because it is used for the treatment of osteoporosis by glucocorticoid (limited to postmenopausal women who did not take estrogen). It was eventually withdrawn from the market due to poor performance. Pletaal 50mg, Pletaal 100mg, Pletaal Powder 20%, Pletaal SR cap, Pletaal OD Tab 100mg, Pletaal OD Tab 50mg, and Pletaal SR cap 200mg are approved for domestic market. But, Pletaal Powder 20%, Pletaal OD Tab 100mg, and Pletaal OD Tab 50mg have been withdrawn. All drugs have been modified for convenience, but the strategy did not work well in the market. All three items are non-reimbursement drugs, and they have not been properly marketed. It was not difficult for Otsuka as products from other lineups are performing well in the market. Looking at the amount of outpatient prescriptions based on UBIST last year, other items excluding 3 items recorded ₩25.1 billion. There are many generics of Cilostazol on the market, but only the original has powder type and OD tablet type.
- Policy
- The redemption of α-GPC benefits extended until March 15
- by Lee, Hye-Kyung Feb 15, 2021 06:17am
- The contract for reimbursement of benefits related to α-GPC, a brain function improvement drug, was extended until March 15th. The MOHW ordered The NHIS to extend the deadline for negotiations on the Choline alfoscerate formulation on the 10th. February 10, which ordered an extension of the negotiation period, marks the end of the first negotiations for the MOHW to end negotiations and contracts for 129 pharmaceutical companies and 227 items of α-GPC(Choline alfoscerate). On December 14, 2020, the MOHW ordered the termination of the contract for reimbursement of benefits for Choline alfoscerate by February 10 in accordance with the Rules on the Standards of National Health Insurance Medical Benefits. A total of 56 pharmaceutical companies, including 28 pharmaceutical companies such as Chong Kun Dang and 28 pharmaceutical companies including Daewoong, among the 129 pharmaceutical companies to be negotiated, have suspended executions and administrative litigation regarding the cancellation of negotiation orders and notifications against the Minister of Health and Welfare and the Chairman of the NHIS. During the negotiation period, the Seoul Administrative Court dismissed pharmaceutical companies' applications for suspension of execution on January 27 and 29, but disapproved with the results as pharmaceutical companies filed appeals. Dissatisfaction with the results of the court had an impact on the negotiation process. This is because there was no pharmaceutical company that agreed to the NHIS' redemption contract until February 10, when the negotiations ended. The MOHW decided to extend the redemption negotiation order for one month. According to Article 2-2, Paragraph 2 of the Drug Price Negotiation Guidelines, in spite of '1 (60 days from the day after the day after the Minister of Welfare ordered the negotiation), each subparagraph (if the Minister of Welfare ordered the negotiation by setting a separate negotiation period), If the Minister of Health and Welfare has ordered a temporary suspension of negotiations or postponement of the negotiation deadline pursuant to Article 11, Paragraph 2 of the Standards for Medical Benefits), it shall be up to a period or time limit separately determined in accordance with each subparagraph. The negotiation period was specified. In the case of Choline alfoscerate, when the NHIS Chairman requests the Minister of Health and Welfare for reasons such as delay in accordance with Article 11-2, Paragraph 7 of the Rules, the deadline may be delayed or temporarily suspended within 60 days. The NHIS will conduct negotiations again for each pharmaceutical company during the extended negotiation period for an additional month. In the event of a clinical trial failure, pharmaceutical companies must agree to return or break down the entire health insurance prescription amount from the date of submission of the clinical protocol to the MFDS to the date of deletion to the NHIS. The reimbursement for the current health insurance prescription amount refers to the total medical care benefit expenses excluding the patient's copayment. However, there is a possibility that it will change during the negotiation process, such as a lawsuit.
- Policy
- NHIS refuses to disclose immunotherapy reevaluation result
- by Moon, sung-ho Feb 15, 2021 06:16am
- Although the National Health Insurance Service (NHIS) has conducted a reevaluation on immunotherapies listed for reimbursement, the government agency decided to keep the outcome undisclosed. On the contrary, the Health Insurance Review and Assessment Service (HIRA) disclosed the outcome of a consignment research done with the same topic. The NHIS’ decision to conceal the outcome has stirred up the relevant industries in South Korea. On Feb. 10, the pharmaceutical and medical industry associates told NHIS has recently injected approximately 250 million won for a year-long research on clinical evidence-based reevaluation on listed immunotherapies, but decided to keep the outcome to themselves. The research was led by the Chairperson of Lung Cancer Committee of Korean Cancer Study Group (KCSG), Professor Ahn Myung Ju at Samsung Medical Center Department of Hematology and Oncology. The study reviewed the treatment efficacy of NHI-listed immunotherapies—Keytruda (pembrolizumab) and Opdivo (nivolumab)—in the real world clinical scene in South Korea, and focused on using the collected data to evaluate the treatments’ cost-effectiveness. The study also designed post-management models by reevaluating the efficacy and cost-effectiveness based on the collected clinical data analysis. According to the study, the agency aims to set up management models based on the NHI finance monitoring. Meanwhile, HIRA also conducted a similar research prior to NHIS. HIRA started the ‘Reevaluation on Immune Checkpoint Inhibitor Treatments’ since 2018, compared to NHIS’ research started from November 2019, and presented the result in the middle of 2019. Coincidentally, the HIRA research was also led by KCSG President, Professor Kang Jin-hyoung at Seoul St. Mary’s Hospital. While the HIRA-sponsored Professor Kang’s research result is open to public, Professor Ahn’s NHIS research is not. Professor Ahn Myung Ju at Samsung Medical Center reserved her comment but said, “From the get-go, NHIS and the researchers agreed to have the research outcome undisclosed. The study would never be open to public. I do not have other comments to make as the consignment contract clarified the confidentiality nature of the study.” But the related industries are disputing over the reasons why NHIS is keeping the research result hidden from the public. Some suspect the government agency feels the pressure of expanding the reimbursement standard to include first-line therapy based on the outstanding analysis result of the immunotherapies. Moreover, the industry’s curiosity is heightening as some industry insiders say the NHIS study touched on wider range of subjects than the HIRA’s. For instance, HIRA’s reevaluation targeted 1,189 patients with advanced or metastatic non-small cell lung cancer (NSCLC), who failed to respond to chemotherapies at top 20 healthcare institutes in South Korea. Apparently, Keytruda and Opdivo’s overall response rate (ORR) demonstrated 35.98 percent and 31.01 percent, respectively, which did not show statistically meaningful difference between those patient groups. However, NHIS research targeted larger patient groups treated from all healthcare institutes around the country. The industry paid a closer attention to the study as it would provide detailed data of the treatments’ efficacy. An oncology department professor, who requested to be anonymous, noted, “The result of a HIRA research on reevaluating immunotherapies was disclosed, whereas the result of a NHIS research on the same topic was turned undisclosed. It is difficult to comprehend the NHIS’ decision. Many of the industry associates think NHIS is silencing the positive reevaluation outcomes of the major immunotherapies’ efficacy.” But NHIS official stated the immunotherapy reevaluation research is undisclosed, because of the principles of the market economy as the research included specific pharmaceutical companies. NHIS also argued there are plenty of other researches kept undisclosed with the similar reasoning. The government agency official added, “In accordance to the Article 9 of the Official Information Disclosure Act, the agency has decided to not open the research result to public, because the details contain various confidential data of specific drugs regarding clinical efficacy and cost-effectiveness.”
- Policy
- Janssen, to close Hyangnam plant in Korea
- by Lee, Tak-Sun Feb 15, 2021 06:16am
- Janssen Korea‘s factory in HyangnamWith the withdrawal of the Hyangnam factory this year, Janssen Korea is reorganizing its domestic product lineup of Tylenol and Ultracet The production of Tylenol 8 hours ER and Ultracet is undergoing a transition or shutdown procedure. According to the MFDS on the 8th, all Ultracet products, an analgesic combination drug containing Tramadol-Acetaminophen, which were produced in the Hyangnam factory, were all converted for export. Accordingly, Ultracet produced at the Hyangnam Plant will soon end its insurance benefits. Ultracet is largely divided into fast-acting tablet typed Ultracet, and sustained-release tablet typed Ultracet ER. It is also divided into Ultracet, Ultracet Semi, Ultracet ER, and Ultracet ER Semi according to the size (the dosage). Janssen Korea’s Ultracet and Ultracet Semi, which were previously produced at the Hyangnam factory, have been converted into export products within the last year. An export item is a product used only for export, not sold in the domestic market. When switching to export, insurance benefits are removed, and insurance claims can be made for six months to close inventory. It will not be sold in the domestic market. Ultracet was converted to an imported product produced at factories in Canada and Italy last May. Janssen of Korea recently sent an official letter to the distribution industry about Ultracet Semi, saying that the provider will be changed to Handok, and that it will be available in June after an administrative procedure. Accordingly, only Ultracet ER and Ultracet ER Semi are produced at Hyangnam Plant. Ultracet ER has a higher sales performance than Ultracet. Based on IQVIA, the cumulative sales for the first half of last year show that Ultracet ER was ₩4.7 billion, Ultracet ER Semi was ₩4.2 billion, Ultracet was ₩2.4 billion, and Ultracet Semi was ₩1.1 billion. As the Hyangnam plant operates until this year and the sale process to Whanin Pharm is completed by March next year, the manufacturer of Ultracet ER products is also expected to change. Janssen Korea is also promoting technology transfer to Handok. Janssen recently sent an official letter to the distributor, saying that it will supply Tylenol 8 hours ER 325mg by April and withdraw. Tylenol 8 hours ER 325mg will be terminated and only Tylenol 650mg will be distributed. Based on IQVIA, the cumulative sales of Tylenol in the first half of last year were ₩12.5 billion, and Tylenol 8 hours ER 325mg was ₩5.7 billion. In August of last year, Johnson & Johnson Korea received a license for Children's Tylenol 160mg from Canada. However, it is not yet known what will happen to Tylenol produced in Korea after the Hyangnam plant is closed.
