Last Updated on January 10, 2025 by The Health Master
Patent
The US pharmaceutical market is poised for significant change in the coming years, with the patent expiration of several blockbuster drugs.
This presents a golden opportunity for Indian generic drug manufacturers to capitalize on increased demand and expand their market share.
Key Drugs Losing Patent Protection
These are the top 10 expiration of patent in the US are:
- Keytruda (Pembrolizumab): A leading cancer immunotherapy drug.
- Eliquis (Apixaban): A widely used blood thinner.
- Eylea: A treatment for age-related macular degeneration.
- Opdivo (Nivolumab): Another immunotherapy drug for cancer.
- Ibrance (Palbociclib): A treatment for breast cancer.
- Xarelto (Rivaroxaban): Another blood thinner.
- Trulicity: A medication for type 2 diabetes.
- Prevnar 13: A vaccine to prevent pneumococcal disease.
- Ocrevus: A treatment for multiple sclerosis.
- Prolia/Xgeva (Denosumab): Medications for osteoporosis and bone metastases.
US Market Significance for Indian Pharma
The US market remains a cornerstone for Indian pharmaceutical companies, contributing significantly to their overall revenue.
With approximately 48% of global pharmaceutical spending concentrated in the US, it presents a highly lucrative market.
Easing Pricing Pressures and Growing Demand
Recent quarters have witnessed a moderation in pricing pressures within the US market.
This, coupled with increasing drug shortages, has created a more favorable environment for generic drug manufacturers.
- Increased Revenue Growth: Indian pharma companies are experiencing robust revenue growth from the US market, driven by higher volumes and improved pricing opportunities.
- Moderate Growth Forecast: While growth in FY2025 is expected to moderate from the exceptional growth observed in FY2024, a significant increase of 9-11% is still anticipated.
Challenges and Mitigating Strategies
- USFDA Scrutiny: A key risk for Indian pharma companies operating in the US market is the stringent regulatory environment. High incidences of warning letters and import alerts from the US Food and Drug Administration (USFDA) can lead to delays in product launches, significant penalties, and increased costs.
- Risk Mitigation Measures: To navigate these challenges, Indian pharma companies are implementing several strategies:
- Portfolio Optimization: Focusing on high-growth segments and diversifying their product offerings.
- Cost Control Measures: Streamlining operations and improving efficiency.
- Complex Molecule Focus: Increasing investment in the development and manufacturing of complex molecules, such as injectables, inhalations, and biosimilars.
In conclusion, the US pharmaceutical market presents a significant growth opportunity for Indian generic drug manufacturers.
By capitalizing on patent expirations, addressing regulatory challenges, and focusing on innovation, Indian companies can solidify their position in this crucial market and continue to contribute to global healthcare access.
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What is the impact of patent expiries on the US drug market?
Patent expiries increase competition, leading to lower drug prices and potentially increased access to affordable medications.
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How do Indian pharma companies benefit from patent expiries?
They can develop and market generic versions of the original brand-name drugs, capturing a significant portion of the market share.
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What are the key challenges faced by Indian pharma companies in the US market?
Stringent regulations, high incidences of USFDA scrutiny, and potential for import alerts.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Disclaimer: This article is for informational purposes only and should not be considered financial or investment advice.
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