- LOGIN
- MemberShip
- 2026-04-17 11:08:06
- Policy
- Amendment to cascading drug price revision revealed
- by Kim, Jung-Ju Jan 30, 2020 06:33am
- Finally came the result. The reinstatement of the cascading drug price system was revised and revised to change the generic insurance price according to whether or not it had its own bioequivalence test. As is known, there is a difference in the price of IMDs and generics. Revisions were included to keep the addition in recognition of the effort and innovation. However, in the case of listed drugs, the application sentence linking permit and drug prices after three years of preparation period is missing from the readministrative notice. This was confirmed that there would be no change as a result of the planned re-evaluation process (3 years) to be carried out through a re-evaluation procedure separately announced according to the 'Criteria for Decision or Adjustment on Drugs'. The Ministry of Health and Welfare announced ‘a partial revision of the Criteria for Decision or Adjustment on Drugs’ today (Jan 28) morning and looked up opinion in the industry. When the first notice amendment was issued on July 2 last year, the government decided to revise the notice in early September and enter into full-scale implementation this year. However, due to the high impact of drug price reform, some additions were inevitable due to continued protests and protests. ◆Standard to estimate the drug price (including eye drops)= Looking at the contents, the first relevant revision notice and the basic framework of July 2 last year are the same. The revised bill for the price standard system, which cuts the generic price by 15% according to its own and co-prosperity into 'stairs' and limits the same number of generics as the so-called 'cut line', was also included in the revised proposal. In detail, a new set of criteria for applying differential prices (submission of biometric data or evidence of clinical trials and the use of registered ingredients) has been established. The cascading reorganization will change the price of the drug depending on the criteria, provided that the same formulations are listed under 19 products. 53.55% if all are met, 45.52% if only one is met, and 38.69% if there is no requirement. In the case of 'A cut off point system', when more than 20 products of the same formulations are listed, it is calculated automatically 85% of the lower amount between the lower price of the upper limit of the same system and the amount calculated as 38.69%. Eye drops are also multi-use or single-use eye drops. However, if the applied product is a single-use or multi-use product, the calculation criteria will be pushed forward. Eye drops are also multi-use or single-use eye drops. However, if the applied product is a single-use or multi-use product, the calculation criteria will be pushed forward. If revised, it will take effect on July 1st. ◆Reorganization of Addition System= The industry's current focus is on this reform. The reorganization plan includes all the contents of the first draft made last year, including the comprehensive maintenance of synthetic and biologic drugs, and the extension of the period of addition. Looking specifically at the addition of IMDs, the IMD maintains the addition until the IMD or the individual single or complex constituting the product and the same route of administration, ingredient, and formulation are listed. This includes IMD complexes. Just this has a condition. Excludes two or more listed companies that have the same dosage, route, ingredient, and formulation as the individual single compound and compound listed in the combination. Also, products added after the addition period has passed cannot be added. In addition, the addition requirements for both synthetic (chemical) and biologics are the same as those published last year. The addition period and the number of companies that have been set for each standard have been unified and maintained. Specifically, the period for adding synthetic and biopharmaceuticals is one year, and if the number of companies is three or less, the period for adding and maintaining all of them is up to two years. However, if the pharmaceutical company wants to extend the addition period, the government prepared a system to adjust the addition rate and extend the addition period within the two-year limit through the review of the Pharmaceutical Benefits Advisory Committee. The government plans to implement this addition system by January 17, next year after receiving opinions.
- Company
- ‘No Japan’ no effect on drug trade with Japan last year
- by Kim, Jin-Gu Jan 30, 2020 06:33am
- Apparently, imported drug volume from Japan has gone up in last year by 8.3 percent. Experts analyze Koreans boycotting Japanese products took off from the latter half of last year had not affected the pharmaceutical industry. According to import and export statistics disclosed by Korea Customs Service on Jan. 28, Korean drug export volume to Japan last year has reached USD 250.6 million, making a significant increase of 48.9 percent from 168.35 million dollars in 2018. The import drug volume was increased by 8.3 percent in the same period from 364.27 million dollars to 394.36 million dollars. Overall, Korea’s pharmaceutical trade deficit with Japan improved from 195.93 million dollars to 143.76 million dollars in the same period. The massive increase in drug export volume has narrowed the gap with the import volume. Trade with Japan in last five years (Unit: USD 1 million) Source: Korea Customs Service ◆ Drug trade unaffected by ’Boycott Japan,’ but trade deficit improved The industry experts see that the so-called ‘No Japan,’ or the boycott on Japanese product, had unnoticeable effect on drug trade and resulted in increased Japanese drug import volume. In fact, the Japanese drug import volume last year hit the highest peak in the recent five years (from 2015 to 2019). However, the trend vastly contrasts with other industry of food and beverage, automobile, consumer goods and tourism. Last year, 39.76 million dollars of Japanese beer was imported to Korea, which halved from 78.30 million dollars made in 2018. The polarizing trend was even more prominent with statistic data from July last year when the boycott was encouraged seriously. In the second half of last year, 202.91 million dollars of drugs were imported from Japan, which leaped by 22.39 million dollars (12.4 percent) from latest three years (from 2016 to 2018) with 180.52 million dollars. Japanese drug volume Korea imported in 2019 (Unit: USD 1 million) Source: Korea Customs Service ◆ Drug export volume hits highest at USD 3.7 billion Last year’s drug export volume from Korea has reached a historic high at 3.7 billion dollars. Regardless, the import volume also hit the highest and the overall trade deficit worsened by a bit. Korea exported 3.7 billion dollars worth of drugs in 2019. It jumped by 13.0 percent from 3.3 billion dollars in 2018. The export volume in last decade surpassed the one-billion-dollar line for the first time in 2012, and broke the two-billion-dollar and three-billion-dollar lines in 2016 and 2018, respectively. Korean drug export volume in last decade (Unit: USD 1 million) Source: Korea Customs Service Despite breaking the highest record of export volume, last year’s trade deficit has gotten slightly bigger from 2.8 billion dollars in 2018 to 3.0 billion dollars in 2019. The deficit worsened because the import volume was broke the highest record. The drug import volume last year marked 6.7 billion dollars, a 9.20-percent increase from 6.1 billion dollars in 2018. As a result, the trade gap widened from 2.8 billion dollars to 3.0 billion dollars. ◆ Top importing country rank changes from the U.S. to Germany The top ranking of countries importing Korean drug the most has been shuffled. The U.S. has been on the top since 2017, but Germany took over last year. Germany and the U.S. have respectively imported 521.31 million won and 435.16 million won worth of Korean drugs last year, and Turkey (402.12 million dollars), Japan (250.64 million dollars) and China (248.05 million dollars) followed the top two countries. Top 10 Korean drug importing countries (Unit: USD 1,000) Source: Korea Customs Service
- Policy
- Rafinlar-Meqsel combination done with pricing negotiation
- by Lee, Hye-Kyung Jan 30, 2020 06:33am
- A combination therapy of Rafinlar and Meqsel treating patients with ultra-rare late stage BRAF-mutant lung cancer would be available for reimbursed prescription from next month at earliest. Korea’s National Health Insurance Service (NHIS) has recently announced pricing negotiations on four items—Novartis’ Rafinlar (dabrafenib) 50 mg and 75 mg, and Meqsel (trametinib) 0.5 mg and 2 mg—have been wrapped. First released for the Korean market in December 2017 as a melanoma treatment, Rafinlar and Meqsel have been additionally indicated to treat patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation in March 2018. And to win reimbursement on the combination therapy of the two, they have been deliberated by Health Insurance Review and Assessment Service’ (HIRA) Cancer Disease Deliberation Committee and Drug Reimbursement Evaluation Committee (DREC) and started a drug pricing negotiation with NHIS from last year. Rafinlar and Meqsel combination therapy has been raised as an issue at the National Assembly audit session last year. During the audit, Liberty Korea Party Lawmaker Kim Se-yeon strongly appealed the need to provide reimbursement on the combination therapy of Meqsel and Rafinlar to treat patients with stage IV lung cancer. However, Ministry of Health and Welfare (MOHW) answered negatively by stating, “Reimbursement for a drug is decided by comprehensively reviewing clinical efficacy, cost-effectiveness and other various factors based on ‘Detailed Evaluation Standard of New Drug for Negotiation,” and “the combination therapy has uncertainty in cost-effectiveness.” While an alternative option of chemotherapy costs 20 million won a year with progression-free survival (PFS) of 8.9 months, MOHW claims the combination therapy of Meqsel and Rafinlar costing 120 million won a year to achieve PFS of 10.9 months is not cost-effective. However, the health authority and Novartis have negotiated financial means to cover the uncertainty in cost-effectiveness, and reached an agreement to complete the pricing negotiation in early January. Health Insurance Policy Deliberation Committee (HIPDC), under MOHW, is scheduled to discuss about the reimbursement decision on Rafinlar and Meqsel combination therapy and to finalize the data providing the reimbursement. Meanwhile, NHIS has also announced Yooyoung Pharmaceutical’s chronic constipation treatment Rucalo tablet (prucalopride succinate) 1 mg and 2 mg, and Astellas Pharma Korea’s overactive bladder treatment Betmiga PR (mirabegron) 25 mg and 50 mg have also finished the pricing negotiation as of Jan. 21.
- Company
- A Employee, ahead of retirement at Merck, took his own life
- by Eo, Yun-Ho Jan 29, 2020 10:55am
- There was a pity that a salesperson at Merck Bio Pharma, who was about to leave, took his own life. According to the industry, Mr. A, a sales representative from Daejeon Branch of Merck, was found dead. Mr. A was included in the Early Retirement Program (ERP) during the sale of Merck's General Medicine primary care (GM) division, and retirement was confirmed in May. The exact cause of suicide is not known yet, and companies, unions, etc. are trying to figure out the truth. Meanwhile, Merck Korea has been experiencing considerable labor and management conflicts until recently after the sale of its GM division last year. The company decided to sell its business units to strengthen its capabilities in areas such as oncology, infertility, neurology and specialty care. Merck signed a sales contract for Glucophage, a diabetes drug, with GC Green Cross in last October, formulating a business division in November. In last November, the company signed a sales contract with Daewoong Pharmaceutical for its hypertension drug 'Concor'.
- Policy
- Janssen prepares to close Hyangnam plant, renewing licenses
- by Lee, Tak-Sun Jan 29, 2020 06:27am
- Janssen Korea is to close Hyangnam plant in 2021 and the company is speeding up the process of transferring items manufactured in Hyangnam to other facilities. Apparently some of them would be transferred to other Korean manufacturing companies, whereas some would be manufactured abroad and imported to Korea. As of Jan. 28, Korea’s Ministry of Food and Drugs Safety (MFDS) cleared Janssen Korea’s antipsychotic medicine, Invega (paliperidone) ER tablet in 3 mg, 6 mg, and 9 mg doses. These items are the same items approved back in April 2010. But the newly approved items would be imported to Korea, unlike the previously approved ones manufactured in Hyangnam plant. Janssen Korea has preemptively notified the change to drug distribution channels in Korea and forewarned the drug supply would be suspended until coming May. With the new license in Korea as an imported drug, Invega is expected to be listed for reimbursement from April. UBIST reported Invega has generated 2.3 billion won in Korea for outpatient prescription last year. The drug manufacturing plant is reportedly moving to Italy from Hyangnam, Korea. And the global company would obtain more new drug import licenses, as Janssen has notified Jurnista SR tablet and Topamax springkle capsule would also be manufactured abroad and imported back to Korea. The existing license on Invega has been returned as of passed Jan. 17. Janssen Korea canceling the license and leaving void period in between licenses are inevitable at the moment. Regardless, Invega Sustenna injection would be supplied without a break. Invega Sustenna, unlike the tablet form, was approved as an imported drug in July 2010. Janssen has already registered the injection’s DMF with Irish and Belgian plants as manufacturer of active ingredient paliperidone. Some items are transferring to other Korean manufacturers. Pain reliever Ultracet is transferred to Handok, and gastro-oesophageal reflux disease treatment Pariet is running bioequivalence test for approval to be transferred to Kolmar Korea. And Tyrenol 8-hour ER tablet is highly likely to be transferred to Handok. Janssen’s Hyangnam plant, built in 1983, would stop its production life of 38 years after a year. As it was the center of global drug manufacturing plant in Korea, the Korean pharmaceutical industry is left with bittersweet sentiment of the plant.
- Company
- Breakthrough anticancer Tagrisso makes KRW 29 billion
- by An, Kyung-Jin Jan 29, 2020 06:26am
- Tagrisso AstraZeneca’s new lung cancer treatment Tagrisso has continued to top the prescription drug market. After two years of reimbursement listing, the new drug has generated almost 30 billion won and expanded the overall epidermal growth factor (EGFR) targeted therapy prescription volume. According to pharmaceutical product research firm UBIST on Jan. 23, Tagrisso’s outpatient prescription volume reached 29 billion won last year. The treatment continued to lead the EGFR targeted therapy market as its outpatient prescription volume rose by 33.7 percent than the previous year at 21.7 billion won. Tagrisso (osimertinib) is a third generation tyrosine kinase inhibitor (TKI) developed to inhibit EGFR T790M resistance mutation. The treatment was approved by Korea’s Ministry of Food and Drug Safety (MFDS) in May 2016 as a once-daily treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), whose T790M has been mutated after being treated with other existing EGFR-TKI options like Iressa (gefitinib), Tarceva (erlotinib), and Giotrif (afatinib). In December 2018, the targeted therapy won an expanded indication as a first-line therapy on patients with locally advanced or metastatic NSCLC and an EGFR exon 19 deletion or exon 21 L858R mutation. Growth of Tragrisso outpatient prescription volume by month (Unit: KRW 1 million) Source: UBIST In December 2017, the first month of reimbursement listing, Tagrisso made 1.7 billion won and teased its future success from early on. From April 2018, its prescription volume soared as Hanmi Pharmaceutical’s Olita (olmutinib) that received reimbursement on the same day as Tagrisso was suspended from development and sales, and Tagrisso became the only third generation EGFR-TKI in the market. The prescription volume steeply peaked at 2.8 billion won in last July, and it has plateaued at around 2.7 billion won since then. But, the overall sales volume is estimated to be even higher as its inpatient prescription is significant. Due to Tagrisso’s exceptional performance, the overall EGFR targeted therapy’s outpatient prescription volume has increased up to 60.4 billion won. The figure has increased by 15.6 percent from the year before, and by 41.5 percent compared to figure prior to 2017 when Tagrisso was listed for reimbursement. Out of all four EGFR-TKIs, Tagrisso’s outpatient prescription takes 48.0 percent of the pie. During the same period, the prescription volume of first generation EGFR targeted therapies—AstraZeneca’s Iressa and Roche’s Tarceva—has been falling. Iressa’s outpatient prescription volume last year reached 17.5 billion won, or 18.3 percent less than the year before. Tarceva’s volume reached 3.6 billion won with 0.4 percent decrease. Boehringer Ingelheim’s second generation EGFR targeted therapy Giotrif’s outpatient prescription volume last year has doubled from the year before and made 10.3 billion won. Apparently, it was the highest figure the targeted therapy has reached since its release in Korea. Major EGFR targeted therapy’s outpatient prescription trend by month (Unit: KRW 1 million) Source: UBIST The pharmaceutical industry predicts the EGFR targeted therapy prescription landscape would take a sharp turn if Tagrisso successfully expands reimbursement on to the new indication as first-line treatment for lung cancer. The market experts expect that the prescription of first-line treatment for NSCLC would skyrocket, if AstraZeneca, which built a strong sales network in lung cancer for long period of time with Iressa, is to concentrate on marketing Tagrisso by differentiating it from other first and second generation drug. It also means Giotrif that just surpassed the ten-billion-won line last year for the first time could bounce back down. AstraZeneca is in the process of applying reimbursement on Tagrisso’s indication as first-line treatment for NSCLC patient. Recently, the company has reportedly applied for reimbursement expansion to Health Insurance Review and Assessment Service (HIRA) based on the findings of Phase 3 clinical study FLAURA that confirmed overall survival of patients with NSCLC, who were treated with Tagrisso as a fist-line treatment.
- Policy
- Korea-Switzerland promulgated an AMR on GMP
- by Lee, Jeong-Hwan Jan 29, 2020 06:26am
- The AMR (Agreement on Mutual Reliance) on GMP (Good Manufacturing Practice) between Korea and Switzerland was promulgated on the 23rd. It is a follow-up after the MFDS (Ministry of Food and Drug Safety) signed a GMP agreement with the SWISSMEDIC (Swiss Drug Agency) on December 18 last year. The agreement promulgated the mutual recognition that strengthening cooperation between Korea and Switzerland would mitigate trade barriers and create mutual benefits. Above all, it reaffirmed its importance in promoting international trade between the Republic of Korea and Switzerland and ensuring the global supply chain integrity of pharmaceuticals and the production of high quality pharmaceuticals. In conclusion, the results of the GMP survey between the MFDS and the SWISSMEDIC can be replaced by a GMP certificate issued in the country. Trust article in the GMP agreement between Korea &Switzerland This shortens the registration period for domestic pharmaceutical and bio companies by exempting GMP evaluation from the SWISSMEDIC. The GMP requirements apply to all human medicines, including investigational medicinal products (IMPs), active pharmaceutical ingredients (APIs), chemicals, biologics (including biologicals) or herbal preparations. Switzerland is one of the strongest pharmaceutical groups in A7 countries, and Korea's GMP system and management level is equivalent to that of Switzerland, which means that Korea's regulatory capacity and pharmaceutical industry are internationally recognized. The A7 countries are the United States, the United Kingdom, France, Germany, Italy, Switzerland, and Japan, which are advanced pharmaceutical countries that are used when deciding or reassessing domestic drug prices. As the ratification takes effect, Korean pharmaceutical companies are exempt from GMP due diligence when exported to Switzerland, and it is expected that market entry will be easier due to cost reduction and shortening of the permit period. In particular, as pharmaceutical quality management and regulatory levels are recognized by Switzerland, the possibility of equal treatment in the European market increases. so it will be a good opportunity for Korean pharmaceuticals to enter the European market.
- Company
- Eylea biosimilar by SCD applies for Phase 3 global IND
- by Lee, Seok-Jun Jan 29, 2020 06:25am
- Samchundang Pharm (SCD) plans to have Phase 3 global clinical trial protocol approved for Eylea’s biosimilar ‘SCD411’ within the first quarter of the year. The protocol approval would be reviewed for 90 days at longest, and green light the company to start the Phase 3 trial by the coming second quarter. The multiregional study is planned to be conducted in the U.S., Europe and Japan with a set number of participants. When the trial in Japan starts, SCD would receive USD 3 million (about 3.4 billion won) as a milestone payment stated on the substance license-out deal. According to pharmaceutical industry on Jan. 23, SCD is submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the first quarter to obtain approval on a Phase 3 global clinical trial testing a biosimilar product of anti-vascular endothelial growth factor (VEGF) medication Eylea (aflibercept). When FDA clears the Phase 3 IND application, clinical trial in each region would be carried out with respective set number of participants. The approval would be reviewed within 90 days. SCD official stated, “Clinical trials in respective regions are ready to start immediately when the IND application is passed. The protocol review takes 90 days at most, but it could be a month at earliest. We are compiling a flawless application. The target schedule is to submit the IND application within the first quarter.” Initiating the study in Japan after the IND application approval would grant SCD three million dollars. In last March, SCD has signed a deal on SCD411 with Japan-based SENJU Pharmaceutical for 50 billion won. The deal gives exclusive sales rights of the drug in Japan. The Japanese company has paid upfront payment of 2.5 billion won, and agreed to pay out 47.5 billion won for achieving each clinical milestone. The Korean company has received total of 11.5 billion won from the upfront payment (2.5 billion won) and CRO deal related to global clinical trials (nine billion won). Preparation for IND approval has already been completed. In last August, SCD announced the company had a successful pre-IND meeting with the U.S. FDA as a preparation process prior to IND application submission. The company explained, at the meeting, the U.S. health authority generally reviewed the SCD 411’s quality equivalence test outcome and clinical protocol and confirmed the candidate medicine would not have an issue proceeding with IND application. Moreover, the company elaborated about the U.S. FDA recommending execution of Phase 3 trial straight without Phase 1, as recommended by European Medicine Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Basically, the company can simultaneously process the marketing approval in the U.S., Europe and Japan and other major global markets with the Phase 3 global clinical trial. The VEGF treatment has relatively high marketability due to rarity of the treatment option. At the moment, the only options available are Bayer’s Elyea (aflibercept) and Novartis’ Lucentis (ranibizumab). The market volume is expected to grow from seven trillion won in 2017 to 13 trillion won by 2026.
- Policy
- Hanmi’s salt-modifying drug for Galvus was approved
- by Lee, Tak-Sun Jan 29, 2020 06:25am
- A salt alteration drug of Galvus(Vildagliptin) by Hanmi, a DPP-4 inhibitor for diabetes was approved. But one indication in the original drug is excluded. It is understood as a strategy to avoid patent The Ministry of Food and Drug Safety approved the generic product (50mg) for Galvus by Hanmi. Unlike the original galvus, this generic has the HCl of the main ingredient, Vildagliptin. There are four efficacy and effectivess (indications) of Vildagle tablet 50mg including ▲monotherapy as an adjunct to diet and exercise therapy to improve glycemic control in patients with type II diabetes, ▲combination with Metformin if no prior diabetes medication has been received and monotherapy is not enough to control blood sugar, ▲concomitant use with Vildagle if Sulfonylureas and Metformin combinations do not provide sufficient glycemic control, ▲and combination with Vildagle when Insulin (Insulin alone or with Metformin) therapy does not provide sufficient glycemic control. One indication, which is concomitant use in case of Sulfonylurea, Metformin or Thiazolidinediones monotherapy does not provide sufficient blood sugar control, is missing compared to the original Galvus 50 mg. This is due to the fact that the Galvus’ Material Patent received an extension of its duration (2 years 2 months 23 days). One of the indications is excluded that Concomitant use is possible for insulin-independent diabetic patients (type II), if diet and exercise therapy are not sufficient to control glycemic control with Metformin, Sulfonylurea, or Thiazolidinedione alone. In other words, with the exception of the indication, it seems to be a strategy to circumvent the scope of rights of the extended patent for material and to release the product at the time of expiration of the material patent (December 9 2019). Hanmi requested a passive judgment on the scope of the rights of Galvus in December last year. If the claim is quoted, the reimbursement process can be used to bring the product to market immediately. This is a different strategy from Ahn-gook Pharm, which was previously approved for the same ingredient. Ahn-gook obtained the same indication as the original Galvus 50mg with Ahn-gook’s generic drug. Instead, due to the problem of extending the life of the material patent, it succeeded to invalidate 187 days of the extended 2 years 2 months 23 days. Thus, it became the sales base from August 30 2021. In addition, the company obtained a successful patent challenge and a generic monopoly 'generic exclusivity' granted to the first applicant. In order for Hanmi to release its products earlier than Ahn-gook, it must be cited by the passive jurisdiction checker who claimed at the end of last year. Hanmi also co-sold Galvus with Novartis in 2014. It is important to note whether the company will compete as a competitor in the former peer market through patent evasion.
- Company
- General hospitals clear Norvasc for pediatric use
- by Eo, Yun-Ho Jan 28, 2020 11:18am
- More general hospitals are reportedly listing Norvasc on their drug codes for pediatric treatment. Pharmaceutical industry on Jan. 28 said respective Drug Committees in Seoul National University Hospital, Severance Hospital and Korea University Guro Hospital cleared Norvasc (Amlodipine) 2.5 mg for prescription from the release in last year to now. The 2.5 mg dose of high blood pressure medicine Norvasc is newly approved dose of the drug and the only calcium channel blocker (CCB) in Korea approved by Ministry of Food and Drug Safety (MFDS) for treating pediatric high blood pressure patients aged six to 17. The pediatric indication allows administrating minimum 2.5 mg or maximum 5 mg of the drug once daily. From 2013 to 2017, the number of child and adolescent patients treated in a hospital for high blood pressure has been increased from 4,500 to 6,497, respectively. A clinical study confirmed the drug’s effect in 268 high blood pressure patients ages six to 17, randomized to be administered 2.5 mg or 5 mg of the drug once daily for first four weeks of treatment. The study outcome found, the 2.5 mg and 5 mg arms demonstrated significantly lower systolic blood pressure than the placebo group. In particular, the study reported 5 mmHg systolic on the 5 mg dose and 3.3 mmHg systolic on the 2.5 mg dose. Pfizer Upjohn Korea has diversified the original amlodipine item’s dose and formulation into Norvasc, Norvasc T, and in lower doses to keep the high market share of the off-patent drug. According to UBIST, Norvasc in last year has generated 58.9 billion won from outpatient prescription and defended its title of top single antihypertensive drug. The drug is the first prescribed drug to have made 100 billion won in 2001. Other pharmaceutical companies in Korea have released products with the same active ingredient, and S-amlodipine drugs that maintain the equivalent effect with lowered dose are also available in the market.
