International Journal of Drug Regulatory Affairs
  • Year: 2024
  • Volume: 12
  • Issue: 3

Lifecycle Management of Generic product in US market

  • Author:
  • Sakshi Dhawad*, Samiksha Dhote, Yash Shegokar, Vinita Kale, Milind Umekar
  • Total Page Count: 9
  • Page Number: 55 to 63

Department of Regulatory Affairs, Smt. Kishoritai Bhoyar College of Pharmacy, Kamptee, Nagpur, 441002, Maharashtra, India

*Corresponding author

Online Published on 01 July, 2025.

Abstract

In the US Market, lifecycle management for generic products includes developing and implementing plans to maximize an item’s market potential from launch to decline. It starts with market research and approval of regulatory involving submission of an Abbreviated New Drug Application (ANDA) to demonstrate bioequivalence to the branded product followed by comprehensive market analysis to identify opportunities and assess rivals. Companies use aggressive pricing and marketing techniques to swiftly increase their market share after a product is approved. Continuous monitoring and adaptability to changes in the market, updates to regulations, and competitive actions are crucial throughout the lifecycle. This review focuses on Market entry strategy, Product launch, Market landscape of Generic Drugs in US.

Keywords

Generic drugs, Lifecycle management, Product launch, USFDA, ANDA, OGD, CDER