BC World Pharm has won approval to sell Narco Sublingual 100㎍, the first generic copy of Abstral Sublingual 100㎍ (ingredient: fentanyl citrate) by Menarini, heralding competition in the opioid drug market, observers said.
The Ministry of Food and Drug Safety on Thursday approved the Korean company to sell Narco as the first generic copy of Abstral exclusively, an opioid pill to treat cancer patients’ acute pain, for nine months.
Under the approval-patent linkage system in Korea, the authorities allow an exclusive sale of a generic for nine months if the generic manufacturer wins a patent lawsuit against the original drugmaker. BC World Pharma is allowed to sell Narco for nine months until next August 15.
Menarini’s patent in Abstral is registered as “fentanyl compound to treat acute pain” and expires on Sep. 24, 2019. Unless patent is nullified or other drugmakers avoid the patent, it is almost impossible for rivals to launch a generic copy until the patent expires.
However, Narco will sell only in 100㎍ doses, while Abstral sells in four doses --100㎍, 200㎍, 300㎍, and 400㎍.
To get the approval for its generic, BC World Pharma in 2016 filed with the Intellectual Property Trial and Appeal Board a patent suit against Menarini over the patent of “fentanyl compound to treat acute pain.” The board recognized BC World Pharma’s claim that it avoided Menarini’s patent by using D-mannitol, smaller than fentanyl, in the compounds of Narco.
Abstral has received benefits from the national health insurance since 2014. It is administered to adult patients aged 18 or more who are on opioid medication due to persistent pain and who have drug tolerance. The pill melts under the tongue within a minute and works within 10 minutes, which is useful for cancer patients with acute pain. The drug’s prescription sales reached 4.37 billion won ($3.98 million) in 2016, according to U-BIST data.
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