Amarin Corporation Receives New Notice from Apotex Amid Ongoing Patent Litigation

Strategic Insights -

Amarin Corporation, a pharmaceutical company specializing in the development and commercialization of cardiovascular and metabolic therapies, received a new notice from Apotex, a generic drug manufacturer, amidst ongoing patent litigation involving the company's flagship product, VASCEPA (icosapent ethyl) 1 gram capsules. This development follows a similar notice sent by Apotex in 2016, highlighting the ongoing efforts by generic companies to challenge Amarin's intellectual property rights.

Key Takeaways:

  • Amarin Corporation received a new notice from Apotex, a generic drug manufacturer, regarding a paragraph IV certification for VASCEPA (icosapent ethyl) 1 gram capsules.
  • This development comes amidst ongoing patent litigation involving Amarin and other generic companies seeking approval for their respective generic versions of VASCEPA.
  • The new notice from Apotex alleged that certain patents listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for VASCEPA are invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of the proposed generic product.
  • Amarin is currently considering an effective response to the new notice and plans to update investors at an appropriate time after making a decision.
  • The company has not received notice of a paragraph IV certification from Apotex for patents listed just for the cardiovascular risk reduction indication, which was based on results from the REDUCE-IT cardiovascular outcomes study.
  • Amarin may receive additional paragraph IV certifications in the future and plans to update investors on any such certifications.

Statistics:

  • Amarin has been engaged in ongoing patent litigation involving VASCEPA since 2016, with various generic companies seeking approval for their respective generic versions of the product.
  • The current notice from Apotex underwent a review of FDA's website, with no approval of the Apotex ANDA obtained to date.
  • The Hatch-Waxman Amendments provide for a 30-month stay on FDA's ability to grant final approval to the proposed generic product in the event of patent litigation.

Sources:

  • Amarin Corporation
  • Apotex
  • U.S. Food and Drug Administration (FDA)
  • Amarin's Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2020
  • Comtex SmarTrend Alert