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

More documents

Recommendations

Info

Tale of Two Cliffs• Big Pharma Patents• GenericsLipitorFlomaxSmallPlavixmolecules100 others
Differentiated Products Now Essentially DriveEconomics of <strong>US</strong> Generics: MylanDuragesicEpiPenPaxil CRDitropan XLPlendilLevothyroxineBystolicRoyaltiesSularBase* EPSTotal EPS (%)Percent incremental contribution to 2008 cash EPS (%)1042 2 1 9Differentiatedproductscontributed**~92% of „08cash EPS271610029*Base EPS includes commodity generics, O-<strong>US</strong> generics, Matrix**Incremental contributionReference: Ronny Gal, Research Analyst, Sanford C. Bernstein & Co. Presentation atGPhA 2009 Annual Meeting
Page 1: US 505(b)(2) RegulatoryPathway and
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 and 20: Benefits of 505(b)(2)• Get out of
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

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

Create successful ePaper yourself

Delete template?

Save as template?