DC District Courthouse

Hatch-Waxman ANDA

Sterne Kessler excels at every phase of Hatch-Waxman ANDA litigation, with deep experience at the interface between patent law and FDA drug approvals.

Sterne Kessler has particular depth and expertise at the interface between patent law and the FDA drug approval process. Our team excels at every phase of the Abbreviated New Drug Application (ANDA) process — assisting generic drug and branded pharmaceutical companies navigate the process to achieve their objectives.

An Abbreviated New Drug Application (ANDA) contains data which, when submitted to the Food and Drug Administration (FDA), provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

We counsel clients in matters arising at the interface between patent law and the FDA approval process. Our practice includes:

  • Patent validity & infringement analyses
  • Exclusivity strategies
  • Preparation of patent certifications for ANDAs and 505(b)(2) applications
  • ANDA- and 505(b)(2)-related litigation
  • Prepare and file patent term extension applications
  • Orange Book listing strategies
  • Appeals before the Court of Appeals for the Federal Circuit