Patent Expiry and Competition Erosion: Organon faces ongoing pressure from patent expirations and the entry of generic and biosimilar competitors, particularly for its established brands, which can significantly reduce revenues and market share for key products.

R&D and Pipeline Development Challenges: The company's future growth hinges on successful research and development, particularly in women's health and biosimilars. Failure to develop or acquire commercially viable new products, or setbacks in clinical trials, could limit long-term revenue streams.

Regulatory Compliance and Approval Risks: Organon operates in a highly regulated environment. Delays or failures in obtaining regulatory approvals for new products or indications, non-compliance with manufacturing standards, or adverse regulatory actions can impede market access and incur penalties.