Korea United Pharm sues 15 drugmakers to protect cough suppressant's patent - Korea Biomedical Review

Korea United Pharm took legal action to protect its patent of antitussive drug Levotics CR Tab. (levodropropizine) against generic copies.

The company said on Tuesday that it filed a lawsuit against 15 generic drugmakers that allegedly infringed upon the patent of Levotics CR Tab.

Korea United Pharm took legal action to protect its patent of antitussive drug Levotics CR Tab. against generic copies.

Korea United Pharm developed Levotics CR Tab. as an incrementally modified drug (IMD) and won the regulatory nod in 2017.

The drug improved the dosing from three times daily to twice daily.

Seventeen companies have obtained approval for generic copies of Levotics CR Tab. based on bioequivalence data. Among them, 14 companies entrusted the production of generic drugs to Genu Pharma (previously Kolmar Pharma). The 14 are Kolon Pharm, Hutecs Korea Pharmaceutical, The U Pharmaceutical, Hyundai Pharmaceutical, Sinil Pharmaceutical, Samjin Pharm, Reyon Pharmaceutical, Samik Pharm, Intro BioPharma, Samchundang Pharm, Aju Pharm, KS Pharm, Dongkoo Bio & Pharma, and Korea Prime Pharm.

Korea United Pharm said Genu Pharma and the 14 manufacturers' generic drug production infringed on its patent for "Method for Preparing Sustained-Release Tablets Containing Levodropropizine."

Korea United Pharm's patent of Levotics CR manufacturing method expires on Feb. 12, 2039.

Because of this patent, Levotics CR tablet improved transportability and long-term storage capacity compared to existing levodropropizine-based drugs, Korea United Pharm said.

To secure evidence for the argument, the company applied for a court's preservation of evidence, it said.

An application for preservation of evidence aims to secure evidence to prove patent infringement before the trial of a full-scale infringement lawsuit. The court can order on-the-spot verification to obtain evidence without prior notice to the company.

"Depending on the outcome of the infringement lawsuit, late-comers will not be able to make generic drugs of Levotics CR. According to drug safety regulations, they also may be subject to cancellation of the permit," an official at Korea United Pharm said.

The official added that they would face a disadvantage in future lawsuits for damages, so this patent suit is drawing particular attention.

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