Part 2 – Hatch-Waxman and BPCIA Overview

March 10, 2015 3:15pm

Christopher E. Jeffers Ph.D.
Mintz Levin Cohn Ferris Glovsky and Popeo PC

Kurt R. Karst
Hyman, Phelps & McNamara, P.C.


  • Comparing the NDA, 505(b)(2) and ANDA (Abbreviated New Drug Application) drug approval routes
  • ANDA filing: what does the FDA require?
  • Showing bioequivalence in an ANDA
  • ANDA Paragraph IV Certification, and response to Notice Letters
  • The role of the Orange Book in the drug approval process: what is it, why is it Orange, and why is it important?
  • Regulatory Exclusivity (FDA)
    • Categories of regulatory (data) exclusivity—NCE (new chemical entity); new indication; NDF (new dosage formulation);
      ODE (orphan drug exclusivity); PED (pediatric exclusivity)’ New antibiotic exclusivity
    • overview of Hatch-Waxman and reforms under MMA
    • the role of Orange Book under Hatch-Waxman vis-à-vis the MMA
      • 30-month stay
      • patent extensions
      • ANDA-filer exclusivity (180 day)


  • Identifying products approved/regulated as biologics
  • Overview of biosimilar (FOB) legislation and regulations
  • The rationale for safety and efficacy concerns surrounding second generation biologics

Exclusivity for Combination Products

  • Exploring exclusivities for combination products comprised of two new Orange Book listed drugs, two old drugs, a new and an old, a listed drug and device, and a listed drug and biological product