Part 2 – Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry

March 13, 2024 3:45pm

Maarika L. Kimbrell
Morgan, Lewis & Bockius LLP


  • 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)


  • 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