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Evolution of the U.S. OTC market 1963 - 2013
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Evolution of the U.S. OTC market 1963 - 2013

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  • 1. EVOLUTION OF THE U.S. OTC MARKET 1963-2013 1970s FDA establishes OTC REVIEW/MONOGRAPH system 1980s Rx-to-OTC switch of hydrocortisone approved for use in OTC first aid and anti-itch meds 1980-1982 recession sharp spike in PL OTC sales Ibuprofen switch approved (1984) Nuprin, Advil, Motrin Many allergy, cough and cold ingredients approved for switch bringing brands like Nyquil, Benadryl, Triaminic, and Actifed to market Loperamide switch approved (Imodium) HDTK takes off with launch of new technologies 1990s 1990-1992 recession PL penetration increases across all categories Robust switch activity: Naproxen sodium (Aleve) 2000s H2 antagonists (Tagamet HB, Pepcid AC, Zantac 75, and Axid AR), Antifungals (Lotrimin AF, Lamisil AT) Yeast infection (Monistat, Gyne-Lotrimin, Vagistat, Femstat), children’s Ibuprofen (Children’s Advil and Motrin), smoking cessation new category (Nicorette, Nicoderm CQ, Nicotrol, Habitrol), eye care (Naphcon-A, Vasocon-A, Opcon-A, Visine-A) Hair regrowth new category (Rogaine) Fewer switches create huge brands Low and non-sedating antihistamines (Claritin, Zyrtec) PPIs (Prilosec OTC and Prevacid 24 Hour) Hyperosmotics (Miralax) Alli creates medicated weight loss market Plan B creates OTC emergency contraceptive market 2008 - great recession begins consumers highly cost-conscious, penetration of PL continues Great recession continues Widespread recalls impact market 2010-2013 J&J and Novartis plants shut down Fexofenadine (Allegra) switch approved FDA issues NSURE Initiative Today NSURE

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