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Pharmaceutical industry

Omeros Corporation Plans to File Patent Infringement Lawsuit Against Par Pharmaceutical

Strategic Insights

— 1 min read

Omeros Corporation announced plans to file a patent infringement lawsuit against Par Pharmaceutical in response to the Abbreviated New Drug Application (ANDA) filed by Par seeking FDA approval to market a generic version of Omeros' commercial drug Omidria. Omidria, approved by the FDA for use during cataract surgery or intraocular lens replacement, is protected by 34 issued patents worldwide. The lawsuit is expected to trigger a 30-month stay of FDA action on Par's ANDA, and Omeros has engaged a prominent Hatch-Waxman litigation team to pursue the case. Despite the potential challenge, Omeros remains confident in the strength of its patent estate and its ability to secure the market exclusivity of Omidria.

Key Takeaways:

  • Omeros plans to file a patent infringement lawsuit against Par Pharmaceutical in response to Par's Abbreviated New Drug Application (ANDA) seeking FDA approval to market a generic version of Omidria.
  • Omidria is protected by 34 issued patents worldwide, including patents listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
  • The lawsuit is expected to trigger a 30-month stay of FDA action on Par's ANDA, allowing Omeros time to pursue its patent infringement claims.
  • Omeros has engaged a prominent Hatch-Waxman litigation team at Covington & Burling LLP to pursue the case.
  • Omidria has received 36-month market exclusivity through the New Product Exclusivity provided by the Federal Food, Drug, and Cosmetic Act.
  • Omeros has also received an additional six months of market exclusivity available upon successful completion of the company's pediatric clinical plan.

Statistics:

  • Approximately 3.8 million cataract and lens replacement procedures are projected to occur in the U.S. in 2015.
  • Omeros owns 34 issued patents worldwide related to Omidria.
  • Omidria has been approved by the FDA for use during cataract surgery or intraocular lens replacement.
  • The Orange Book patents protecting Omidria have terms extending to as late as 2033.
  • Par Pharmaceutical has a history of challenging branded drug products.

Sources:

  • PR Newswire, "Omeros Corporation to File Patent Infringement Lawsuit Against Par Pharmaceutical" (Aug 17, 2015)
  • Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2015 (Source: Omeros Corporation, SEC Filing)

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