US 505(b)(2) Regulatory Pathway and Strategies

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505(b)(2) Risks• Imprecise development costs and timelines– ANDA‟s have few re-do‟s of BE– Recruitment of patients not naive– Uncertain dose (Phase 2)• Unknown competition– Other companies can target the same opportunity20
505(b)(2) Risks• Uncertain market acceptance– Formulary– Sales Force– Doctors– Patients21
Page 1 and 2: US 505(b)(2) RegulatoryPathway and
Page 3 and 4: Differentiated Products Now Essenti
Page 5 and 6: 505(b)(2) RegulationPotential 505(b
Page 7 and 8: 505(b)(2) NDAReference Listed Drug
Page 9 and 10: Industry ExamplesHighlighting the B
Page 11 and 12: Corporate StrategyMr. Sims: Actuall
Page 13 and 14: Case Study: Ulesfia TM - Excipient
Page 15 and 16: Pro-Drugs• Fundamental:- Where do
Page 17 and 18: Valacyclovir Regulatory Path• 505
Page 19: Benefits of 505(b)(2)• Get out of
Page 23 and 24: 505(b)(2) Risks• Like Generics (5
Page 25: Thank You• Regulatory Sciences Co

US 505(b)(2) Regulatory Pathway and Strategies

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