Axinn’s FDA Practice Group provides counseling and litigation services relating to the approval, development and marketing of new and generic drug products.  The firm actively represents clients before the Food and Drug Administration – both informally and formally through the Citizen Petition process and in litigation.  By coupling the firm’s knowledge of the regulatory landscape with the firm’s in-house scientific capability and patent litigation expertise, the firm offers a comprehensive team to enable companies to bring drug products to market in the most efficient, competitive and profitable manner.

The group has extensive experience navigating the intricacies of the Hatch-Waxman Act,  including: ANDA requirements; patent listing and certification issues; Paragraph IV certifications and notice letters; 180-day generic marketing exclusivity; forfeiture of the exclusivity period under the 2003 Medicare Modernization Act; 30-month stays; Bioequivalence; Pediatric exclusivity; New Chemical Entity and New Dosage Form exclusivity; patent term extensions and labeling carve-outs and requirements.

Representative examples of FDA litigation include:

• Litigation for Watson of case involving pioglitazone
• Litigation for Alvogen of case involving vancomycin
• Litigation for Actavis of case involving lisdexamfetamine
• Litigation for Purepac of case involving metformin

News

• Chad Landmon Named to Law360's Life Sciences "Rising Star" List
• Axinn Obtains Favorable Decision in FDA Suit
• Axinn, Veltrop & Harkrider Obtains Summary Judgment Victory Against FDA
• Axinn Partner Chad Landmon Honored as Hartford Business Journal “40 Under 40” Winner

Articles & Newsletters

• 2012 Court Decisions Impact the Life Science Industry