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KV Pharmaceutical Reaches Agreement with U.S. Department of Justice

evenue, assets and liquidity and capital resources;
  • changes in the current and future business environment, including interest rates and capital and consumer spending;
  • the difficulty of predicting FDA approvals, including timing, and that any period of exclusivity may not be realized;
  • the possibility of not obtaining FDA approvals or delay in obtaining FDA approvals;  
  • acceptance of and demand for the Company's new pharmaceutical products;
  • the introduction and impact of competitive products and pricing, including as a result of so-called authorized-generic drugs;
  • new product development and launch, including the possibility that any product launch may be delayed;
  • reliance on key strategic alliances;
  • the availability of raw materials and/or products manufactured for the Company under contract manufacturing arrangements with third parties;
  • the regulatory environment, including regulatory agency and judicial actions and changes in applicable law or regulations;
  • fluctuations in revenues;
  • the difficulty of predicting international regulatory approvals, including timing;
  • the difficulty of predicting the pattern of inventory movements by the Company's customers;
  • the impact of competitive response to the Company's sales, marketing and strategic efforts, including the introduction or potential introduction of generic or competing products against products sold by the Company and its subsidiaries;
  • risks that the Company may not ultimately prevail in litigation, including challenges to the Company's intellectual property rights by actual or potential competitors or to the Company's ability to market generic products due to brand company patents and challenges to other companies' introduction or potential introduction of generic or competing products by third parties against products sold by the Company or its subsidiaries, including without limitatio

  • SOURCE KV Pharmaceutical Company
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