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Pharmaceutical industry

Barr Pharmaceuticals Secures License to Manufacture and Market Generic Fentanyl Product

Strategic Insights

— 1 min read

Barr Pharmaceuticals, Inc., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., has entered into an agreement with Cephalon, Inc. that provides the company with a license to manufacture and market a generic version of Cephalon's ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II] cancer pain management treatment. The license will become effective on February 3, 2007, or earlier, depending on certain contingencies. ACTIQ is indicated for the treatment of breakthrough cancer pain in opioid-tolerant patients and has current annual sales of approximately $319 million, based on IMS sales data for the twelve months ended June 2004.

Key Takeaways:

  • Barr Pharmaceuticals will obtain a license to manufacture and market a generic version of Cephalon's ACTIQ (oral transmucosal fentanyl citrate) [C-II] cancer pain management treatment.
  • The license will become effective on February 3, 2007, or earlier, depending on certain contingencies.
  • Barr will have the right to manufacture and market a generic version of Cephalon's proposed sugar-free formulation of ACTIQ under certain circumstances.
  • The agreement is contingent upon final FTC approval and consummation of the merger between CIMA and Cephalon.
  • ACTIQ has current annual sales of approximately $319 million, based on IMS sales data for the twelve months ended June 2004.
  • Barr Pharmaceuticals, Inc. will operate through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., to develop, manufacture, and market generic and proprietary pharmaceuticals.

Statistics:

  • Current annual sales of ACTIQ: approximately $319 million (based on IMS sales data for the twelve months ended June 2004)
  • License effective date: February 3, 2007 (or earlier, depending on contingencies)
  • Number of subsidiaries operating under Barr Pharmaceuticals, Inc.: 2 (Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc.)
  • Date of current data for ACTIQ sales: June 2004 (IMS sales data)

Sources:

  • Barr Pharmaceuticals, Inc. press release (Exact quote: "License to Manufacture and Market Generic Fentanyl Product")
  • Cephalon, Inc.
  • IMS sales data (Exact citation: "IMS sales data for the twelve months ended June 2004")
  • U.S. Federal Trade Commission (FTC) consent agreement (Exact reference: "U.S. Federal Trade Commission (FTC) consent agreement")

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