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Listing of Drug Product Information by Exclusivity Expiration - 2009

Range: 1 - 5

ApplicantTradenameGeneric NameNDAApproval DateExclusivity ExpirationPatented / Exclusive Use
Sanofi Aventis UsKETEKtelithromycin021144Apr 1, 2004Apr 1, 2009 NEW CHEMICAL ENTITY
Sanofi Aventis UsKETEKtelithromycin021144Feb 9, 2005Apr 1, 2009 NEW CHEMICAL ENTITY
NovartisLESCOLfluvastatin sodium020261Dec 31, 1993Apr 10, 2009ADJUNCT TO DIET TO REDUCE TOTAL-C, LDL-C AND APO B LEVELS IN ADOLESCENT BOYS AND GIRLS WHO ARE AT LEAST ONE YEAR POST-MENARCHE, 10-16 YEARS OF AGE, WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
NovartisLESCOL XLfluvastatin sodium021192Oct 6, 2000Apr 10, 2009ADJUNCT TO DIET TO REDUCE TOTAL-C, LDL-C AND APO B LEVELS IN ADOLESCENT BOYS AND GIRLS WHO ARE AT LEAST ONE YEAR POST-MENARCHE, 10-16 YEARS OF AGE, WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
NovartisFOCALIN XRdexmethylphenidate hydrochloride021802Aug 1, 2006Apr 11, 2009REVISIONS TO CLINICAL STUDIES - CHILDREN AND ADOLSCENTS BASED ON CLINICAL TRIAL DATA TO SUPPORT A DURATION OF ACTION CLAIM UP TO 12 HOURS

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All listed trade names are property of their owners or licensors.
Raw information from FDA Orange Book, USPTO and other sources. Copyright © 2009 thinkBiotech LLC


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