‘Blockbuster’ product related patents to be end one by one… Medicine in ‘generic drugs war’
Kim Ji Seob | cloud50@ | 2018-01-10 11:19:49
Korean pharmaceutical companies are showing signs of war on generic drugs ahead of the expiration of many original drug patents this year. In the case of Viagra, a drug for erectile dysfunction, dozens of generic drugs were poured out in 2012 after the patent expired.
According to the Korea Food and Drug Administration (KFDA) on January 9, the number of patents for blockbuster products will expire this year. Gilliad`s hepatitis B treatment `Viridor`, which ranked second in total drug sales by the amount of KRW 116.9 billion in 2016, will expire in November of last year, and new salt-related patents will expire in November. Salts are substances that are not directly related to drug efficacy but affect solubility. Competition in the hepatitis B treatment market is expected to become even more intense as Viridec`s patent barriers disappear. In November last year, Gillier Ad launched the "BemliDi", which improved safety in the existing Biriard, and also defended the market.
Meanwhile, AstraZeneca`s asthma treatment "Symbicort Tabu Heller" will expire on January 13, the composition patent for the stabilization of the drug and ingredient combination. The Symbicort Tabu Heller is the only product to be released in 2016 with a prescription value of about KRW 11.2 billion, and the DuoRespie Spiromax was the only competitor. However, it is noteworthy that DuoLespie will be able to increase its market share in the subsequent generic drug market, as it is still in the KRW 170 million prescription by the third quarter of last year. Mitsubishi Tanabe`s `Diquas-es eye drops`, the market leader in the treatment of dry eye syndrome, is the drug that recorded the prescription amount of KRW 8.9 billion in 2016, and the patent for the drug will expire in July. In the case of DIKOAS, Hanmi Pharmaceutical, Chong Kun Dang, and Samchon Dang Pharmaceutical Co., Ltd. were allowed to release the product at the end of the patent after the patent was invalidated last December in the invalidation lawsuit.
Besides, Pfizer`s Vivienne, a drug for osteoporosis, which had a prescription value of W7.4bn in 2016, will expire on December 14th. Currently, Kolmar Korea, Inynth Biopharmaceuticals, and Hyundai Pharmaceuticals are reported to be developing Vivant Defibrillator.
On the other hand, Roche`s anticancer drug Avastin and Lucentis, a Novartis retinal disease drug, will expire on April 3. As of 2016, Avastin is a large product with sales of KRW 80.6 billion and Lucentis with KRW 19.6 billion. Unlike synthetic medicines, biosimilar developers are limited to Samsung and Celltrion, so their impact on the market is limited for the time being. With regard to Avastin Biosimilars, Samsung BioEpis is in Phase 3 clinical trials and Celltrion is in Phase 1 clinical trials. Samsung BioEpis and BioShindi are in Phase III clinical trials and Phase I of Lucentis biosimilars, respectively. An expert from the pharmaceutical industry said, "In accordance with the strengthening of the patent strategy of domestic pharmaceutical companies, some have preempted the market through patent invalidation and patent avoidance before the patent expiry date.
By Kim Ji Seob cloud50@
[ copyright ⓒ The Digitaltimes ]
According to the Korea Food and Drug Administration (KFDA) on January 9, the number of patents for blockbuster products will expire this year. Gilliad`s hepatitis B treatment `Viridor`, which ranked second in total drug sales by the amount of KRW 116.9 billion in 2016, will expire in November of last year, and new salt-related patents will expire in November. Salts are substances that are not directly related to drug efficacy but affect solubility. Competition in the hepatitis B treatment market is expected to become even more intense as Viridec`s patent barriers disappear. In November last year, Gillier Ad launched the "BemliDi", which improved safety in the existing Biriard, and also defended the market.
Meanwhile, AstraZeneca`s asthma treatment "Symbicort Tabu Heller" will expire on January 13, the composition patent for the stabilization of the drug and ingredient combination. The Symbicort Tabu Heller is the only product to be released in 2016 with a prescription value of about KRW 11.2 billion, and the DuoRespie Spiromax was the only competitor. However, it is noteworthy that DuoLespie will be able to increase its market share in the subsequent generic drug market, as it is still in the KRW 170 million prescription by the third quarter of last year. Mitsubishi Tanabe`s `Diquas-es eye drops`, the market leader in the treatment of dry eye syndrome, is the drug that recorded the prescription amount of KRW 8.9 billion in 2016, and the patent for the drug will expire in July. In the case of DIKOAS, Hanmi Pharmaceutical, Chong Kun Dang, and Samchon Dang Pharmaceutical Co., Ltd. were allowed to release the product at the end of the patent after the patent was invalidated last December in the invalidation lawsuit.
Besides, Pfizer`s Vivienne, a drug for osteoporosis, which had a prescription value of W7.4bn in 2016, will expire on December 14th. Currently, Kolmar Korea, Inynth Biopharmaceuticals, and Hyundai Pharmaceuticals are reported to be developing Vivant Defibrillator.
On the other hand, Roche`s anticancer drug Avastin and Lucentis, a Novartis retinal disease drug, will expire on April 3. As of 2016, Avastin is a large product with sales of KRW 80.6 billion and Lucentis with KRW 19.6 billion. Unlike synthetic medicines, biosimilar developers are limited to Samsung and Celltrion, so their impact on the market is limited for the time being. With regard to Avastin Biosimilars, Samsung BioEpis is in Phase 3 clinical trials and Celltrion is in Phase 1 clinical trials. Samsung BioEpis and BioShindi are in Phase III clinical trials and Phase I of Lucentis biosimilars, respectively. An expert from the pharmaceutical industry said, "In accordance with the strengthening of the patent strategy of domestic pharmaceutical companies, some have preempted the market through patent invalidation and patent avoidance before the patent expiry date.
By Kim Ji Seob cloud50@