October 22, 2024

4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA

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FDA Regulatory partner, George O’Brien will discuss “Comprehending the Intricacies of Non-Patent/ Regulatory Exclusivity” during ACI’s Hatch-Waxman and BPCIA Proficiency Series, a virtual three-week program designed to provide new lawyers and executives for the life sciences industry with a solid foundation for understanding the essentials as well as the intricacies of Hatch-Waxman and BPCIA litigation and regulation.

The panel will discuss:

  • Understanding which drug products are eligible for regulatory exclusivity
    • small biologics v. biologics
  • The different modes and methods of regulatory exclusivity (non-patent)
    • NCE (new chemical entity): 5 years marketing exclusivity/5 years data exclusivity
    • indication (new indication or use): 3 years marketing exclusivity
    • NDF (new dosage formulation)
    • ODE (orphan drug exclusivity)
    • PED (pediatric exclusivity)
  • FD&C 505b2 (alternate pathway to ANDA) a/k/a paper NDA
  • What role does the FDA play in regulating these modes of exclusivity?
  • When are each of these methods sought?
  • Using trade dress as means of exclusivity

For more information and to register, please visit the event webpage.

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