Risk management is a critical concern for pharmaceutical businesses, especially when introducing new products to consumers. Glenmark, a worldwide pharmaceutical firm, confronted an obstacle when it created a low-cost variation of the proprietary medication Tarka, which is used for the treatment of adult hypertension.
Tarka’s patent was scheduled to expire in February 2015, and Glenmark had requested approval from the US Food and Drug Administration (FDA) to sell the low-cost variation in the US (Chandrasekhar, 2021, p. 1). However, Sanofi-Aventis challenged the request in the United States District Court for the District of New Jersey in December 2007 (Chandrasekhar, 2021, p. 1). Glenmark management considered starting its version of Tarka while anticipating the hearing for the ultimate decision at the District Court of New Jersey. Glenmark management was divided on whether to continue with Launch @ Risk and whether it should bargain with Sanofi-Aventis to postpone the launch until six months before the patent expired.
Based on the information provided in the piece, it can be determined that Glenmark’s risk management methods for Launch @ Risk were prudent and well-considered. The business was mindful of the possible legal and financial risks of releasing the generic form of Tarka before settling outstanding patent cases. Glenmark management considered Launch @ Risk and bargaining with Sanofi-Aventis to postpone the debut until six months before the patent expired. In November 2007, the firm filed an Abbreviated New Drug Application (ANDA) with the FDA, requesting approval to sell the low-cost variant in the United States (Chandrasekhar, 2021, p. 1). The filing procedure was shortened because the FDA canceled the prerequisite of performing extensive clinical trials, which the patent proprietor had already finished. Furthermore, Glenmark was the only organization to obtain FDA clearance to sell the generic form of Tarka, showing that the company had observed all regulatory processes and standards. The business also evaluated the product’s intricacy and market share, which were parameters other generics firms did not consider when choosing whether to conduct a Launch @ Risk.
In conclusion, the risk management practices at Glenmark regarding Launch @ Risk were careful and well-prepared. The company had weighed the potential legal and financial dangers associated with launching the generic version of Tarka before resolving outstanding patent lawsuits against it. Glenmark had observed the necessary regulatory processes and requirements and had taken into account the complexity of the product and the extent of the market.
Reference
Chandrasekhar, R. (2021). Glenmark Generics Inc.: Launch @ risk (No. W15238). Richard Ivey School of Business Foundation.