[비즈한국] With 48 pharmaceutical-related patents set to expire this year, attention is focusing on whether generic drugs will be released. The pharmaceutical industry is closely watching products such as Boehringer Ingelheim Korea’s Mirapex ER, Pfizer Korea’s Xeljanz, and Bayer Korea’s Nexavar.
According to the Ministry of Food and Drug Safety’s drug patent list on the 9th, 48 patents covering a total of 94 items will expire this year. While the list initially indicated 76 patents (143 items) expiring this year, 28 of those patents (49 items) were removed due to patent invalidation trials or the cancellation of product licenses.
Industry insiders believe that competition for generic manufacturing could arise for products such as Boehringer Ingelheim Korea’s Mirapex ER (ingredient: pramipexole dihydrochloride monohydrate), Pfizer Korea’s Xeljanz (ingredient: tofacitinib citrate), and Bayer Korea’s Nexavar (sorafenib tosylate). These patents are set to expire on July 25, November 22, and September 20, respectively.
In the case of the Parkinson’s disease treatment Mirapex ER, companies like Samil Pharmaceutical000520, Myungin Pharm, and Hyundai Pharm004310 have been selling generics by bypassing the patent since 2019. For Xeljanz, a rheumatoid arthritis treatment, over 50 companies have received product approval and are considering entering the market. For the liver cancer drug Nexavar, Hanmi Pharmaceutical128940 is the only company that has developed a generic. Initially, companies like Kwang Dong Pharmaceutical009290 also attempted to enter the market, but discontinued their efforts last year due to a significant decline in sales.
Compared to last year, there are fewer major product patent expirations this year. Last year, patents for products such as Bayer’s macular degeneration treatment Eylea and Hanmi Pharmaceutical’s hypertension treatment Amosartan expired, signaling intense competition.