Impax Laboratories Initiates Patent Challenge for Generic Version of Daiichi Sankyo's Welchol

Strategic Insights -

Impax Laboratories Inc has taken the first step in challenging the patents associated with Daiichi Sankyo's Welchol by filing an Abbreviated New Drug Application (ANDA) with a paragraph IV certification with the US Food & Drug Administration (FDA). Following acceptance of the ANDA for filing, Impax notified the patent owners of its paragraph IV certification, leading to a patent infringement lawsuit filed by Daiichi Sankyo and Genzyme Corp in the US District Court for the District of Delaware. This marks the beginning of the patent challenge process under the Hatch-Waxman Act, with Global Pharmaceuticals, Impax's generic division, poised to commercialize the generic version of Welchol once the ANDA is approved. Welchol is a widely used medication for treating high cholesterol and diabetes.

Key Takeaways:

  • Impax Laboratories Inc has filed an ANDA with a paragraph IV certification for a generic version of Daiichi Sankyo's Welchol with the US FDA.
  • The notice to the patent owners triggered a patent infringement lawsuit by Daiichi Sankyo and Genzyme Corp in the US District Court for the District of Delaware.
  • Welchol is indicated as an adjunct to diet and exercise to reduce LDL-C in patients with primary hyperlipidemia and as a treatment for heterozygous familial hypercholesterolemia and Type 2 diabetes mellitus.
  • Impax Laboratories Inc is a technology-based specialty pharmaceutical company with expertise in formulation and drug delivery technology.
  • Global Pharmaceuticals, Impax's generic division, will commercialize the generic version of Welchol once the ANDA is approved.
  • US sales of Welchol for Oral Suspension were approximately $39 million for the twelve-month period ending September 2010.
  • Daiichi Sankyo and Genzyme Corp's lawsuit formally initiates the patent challenge process under the Hatch-Waxman Act.
  • Impax was notified of the lawsuit on November 19, 2010.

Statistics:

  • $39 million: US sales of Welchol for Oral Suspension for the twelve-month period ending September 2010.
  • 19 November 2010: Impax was notified of the patent infringement lawsuit by Daiichi Sankyo and Genzyme Corp.
  • 3.75 gm/packet and 1.875 gm/packet: The multiple potencies of Welchol's Oral Suspension presented in the patent challenge.

Sources:

  • Impax Laboratories Inc news release
  • Daiichi Sankyo and Genzyme Corp's patent infringement lawsuit
  • US FDA letter accepting Impax's ANDA for filing
  • Wolters Kluwer Health, US sales of Welchol for Oral Suspension
  • Impax Laboratories Inc's corporate website