Korean pharmaceuticals are desperate to find ways to avoid the patent rights of Betmiga PR. (ingredient name: Mirabegron) made by Astellas Pharma to cure overactive bladder syndrome. They want to make similar drugs, but can’t because the patent will expire more than 10 years later.
Astellas Pharma released Betmiga PR. in 2015 to treat overactive bladder syndrome. It cures some symptoms such as urgency, frequency, or urgency incontinence. The drug is covered by insurance: 574won for 25mg one tablet and 861won for 50mg one tablet. Recommended dosage is 50mg, once a day.
Doctors and patients welcomed the release of Betmiga PR. because the drug decreased side effects of existing anticholinergic drugs. Betmiga PR. doesn’t affect bladder contraction, can improve overactive bladder syndrome by expanding bladder capacity, and decrease dry mouth and constipation. It is also effective to decrease frequency caused by benign prostatic hyperplasia.
Due to these advantages, the sale of Betmiga PR. stood at about 3.7billion won, 2 months after it had been released in October 2015 and recorded about 28.1billion won in 2016.
Because of increase in patients with overactive bladder syndrome and popularity of Betmiga PR, Korean pharmaceuticals have tried to develop ‘incrementally modified drugs’ that don’t infringe the patent rights.
A total of 10 patents about 25mg and 50mg Betmiga PR are registered in the patent list of MFDS (Ministry of Food and Drug Safety). With each patent involved in about 29-55 trials, Korean pharmaceuticals are paying a lot of attention to this drug
Korean pharmaceuticals pay much attention to the drug. The patents of the drug is involved in about 29-55 trials.
Chong Kun Dang pharmaceutical filed a negative patent scope declaration trial to Intellectual Property Trial and Appeal Board. It argued the drug that the company wanted to develop didn’t infringe the patent rights of ‘Stable Medicinal Compositions for Oral Use’ (1st August 2020) and ‘Controlled Release Pharmaceutical Composition’ (28th September 2029).
But it wasn’t easy to avoid the patent. Last year, Korean pharmaceuticals such as KyungDong Pharm, Ahngook Pharm, INTRO Pharm & Tech, ILDONG Pharmaceutical, HanWha Pharma, and Huons etc. filed patent trials, but lost all cases.
<© Korea Biomedical Review, All rights reserved.>