Drugs

• Overview of Hatch-Waxman and reforms
  • 30-month stay; patent extensions; ANDA filer exclusivity (180 day)
  • ANDA filer patent challenge and competitive generic therapy 180-day exclusivities
• Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes
  • Reviewing fundamentals of applications
• Exploring the ANDA Paragraph IV Certification, and response to Notice Letters
• Examining ANDA Standards for approval and the concepts of sameness and bioequivalence
• Special considerations: local acting drugs, labeling carve outs and other nuances
  • Understanding the role of the Orange Book in the drug approval process
  • listings, de-listings and use codes
• Market exclusivities and protection
• Identifying the different types of exclusivities
  • Regulatory exclusivity (FDA)/ (data) exclusivity
    • NCE (new chemical entity)
  • 5 years data exclusivity
    • indication (new indication or use)
  • 3 years marketing exclusivity
    • NDF (new dosage formulation)
  • 7 years marketing exclusivity
    • ODE (orphan drug exclusivity)
  • 6 months marketing exclusivity
    • PED (pediatric exclusivity)

Biologics

• Overview of biosimilar legislation and regulations, i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
• Understanding the rationale for safety and efficacy concerns surrounding second generation biologics
  • Exploring the concepts of “biosimilarity” or “interchangeability”
  • FDA rule-making and guidance relative to biosimilars
  • Other points for consideration: substitution, naming, patents, and additional nuances
  • Examining biosimilar exclusivities
  • “Shall we dance” — weighing the pros and cons of participating in the patent dance
  • Deciding when to provide notice of commercial marketing