US 505(b)(2) Regulatory Pathway and Strategies
US 505(b)(2) Regulatory Pathway and Strategies US 505(b)(2) Regulatory Pathway and Strategies
505(b)(2) Benefits• Able to earn exclusivity– 3 years: clinical studiesessential for approval– 5 years: NCE – old drugsnever approved under an NDA– 7 years: Orphan Drug18
Benefits of 505(b)(2)• Get out of competitive environment of Generics• Regulatory Review Period (10 months)• May be attractive for investors– 505(b)(2) allows for clinical differentiation– Market potential may be greater than generics19
- 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: Valacyclovir Regulatory Path• 505
- Page 21 and 22: 505(b)(2) Risks• Uncertain market
- Page 23 and 24: 505(b)(2) Risks• Like Generics (5
- Page 25: Thank You• Regulatory Sciences Co
Benefits of <strong>505</strong>(b)(2)• Get out of competitive environment of Generics• <strong>Regulatory</strong> Review Period (10 months)• May be attractive for investors– <strong>505</strong>(b)(2) allows for clinical differentiation– Market potential may be greater than generics19
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