Sterne Kessler Goldstein Fox

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 ANDA's & 505(b)(2) Applications
• ANDA & 505(b)(2)-related Litigation
• Prepare & file Patent Term Extension Applications
• Orange Book Listing Strategies
• Appeals before the Court of Appeals for the Federal Circuit