Breckenridge’s in-house legal department offers diverse expertise covering the entire spectrum of commercial, regulatory and intellectual property functions necessary for ANDA development, submission, prosecution and approval. We also possess and maintain the commercial, compliance and licensing expertise necessary to support the distribution of pharmaceuticals to our diverse customer base throughout the United States.
Breckenridge can provide full legal support to our partners, including:
- Patent assessment from initial review to detailed analysis;
- Legal, intellectual property and market landscape due diligence;
- Support for ANDA submission and prosecution; and
- Litigation expertise in federal and state courts across the United States, including Hatch-Waxman Paragraph IV litigation.