Part 2 – Hatch-Waxman and BPCIA Overview
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
- 30-month stay
- patent extensions
- ANDA-filer exclusivity (180 day)
- Categories of regulatory (data) exclusivity—NCE (new chemical entity); new indication; NDF (new dosage formulation);
- 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