Biocon, an Indian generic drug manufacturer, has been hit with a patent infringement complaint in the US District of New Jersey by Impax Laboratories. The complaint is related to Biocon’s Abbreviated New Drug Application (ANDA) to sell a generic version of the Parkinson’s drug Rytary. The patents-in-suit include US Patent Nos. 8,557,283, 9,089,608, 9,463,246, 9,533,046, and 9,901,640, as well as other Rytary patents listed in the FDA’s Orange Book.
This development comes as a significant challenge for Biocon, which is already facing intense competition in the generic drug market. The company is known for its innovative approaches to drug making, including the use of biotechnology and biosimilars. However, this complaint may force Biocon to re-evaluate its strategy and potentially delay the launch of its generic version of Rytary.
The patents-in-suit are a key part of Impax’s intellectual property portfolio, and the lawsuit could have significant implications for the generic drug industry. The dispute highlights the need for companies to carefully navigate the complex web of patents and intellectual property rights when developing and marketing new medicines.
The outcome of this lawsuit could have far-reaching implications for Biocon and the broader generic drug industry. As the world’s leading source of regulatory change, MLex provides real-time updates and analysis on the latest developments in the pharmaceutical industry. With our expertise, you’ll be better equipped to anticipate and respond to changes in the regulatory landscape, ensuring your business remains ahead of the curve.