Lifecycle Management of Generic product in US market

  • Sakshi Dhawad Department of Regulatory Affairs, Smt. Kishoritai Bhoyar College of Pharmacy, Kamptee, Nagpur, Maharashtra, India 441002
  • Samiksha Dhote
  • Yash Shegokar Smt. Kishoritai Bhoyar College of Pharmacy, Kamptee, Nagpur
  • Vinita Kale
  • Milind Umekar
DOI https://doi.org/10.22270/ijdra.v12i3.693

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

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Dhawad S, Dhote S, Shegokar Y, Kale V, Umekar M. Lifecycle Management of Generic product in US market. Int J Drug Reg Affairs [Internet]. 2024Sep.15 [cited 2026Jan.31];12(3):47-4. Available from: https://www.ijdra.com/index.php/journal/article/view/693
Issue
Vol 12 No 3 (2024): VOLUME 12, ISSUE 3, 2024
Section
Review
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