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Presentation Materials in English [pdf] - United States Patent and ...

Presentation Materials in English [pdf] - United States Patent and ...

PROTECTION OF

PROTECTION OF UNDISCLOSEDINFORMATION:U.S. DATA EXCLUSIVITY SYSTEMNew Chemical Entities- protectionagainst reliance on innovator information:• Pharmaceuticals - 5 years from approval– Drug that contains no active ingredientpreviously approved by FDA– FDA grants 5-years of data protection basedon the active ingredient– Generally prohibits FDA from accepting a505(b)(2) application or an Abbreviated NewDrug Application (ANDA) for a drug productcontaining that active ingredient from 5-yearsof the date of approval of the first new drugapplication (NDA)

PROTECTION OF UNDISCLOSEDINFORMATION: U.S. DATA EXCLUSIVITYSYSTEM• Products containing a chemical entity which has been previouslyapproved - protection against reliance on innovator information:– New Clinical Information (Pharmaceuticals) – 3 years from approval• Granted for certain changes in a drug product• Application or supplement must contain reports of new clinical(human) investigations essential to approval• Protection begins at the time of product approval and coversonly the change in the product supported by the new clinicalstudies• FDA cannot approve a section 505(b)(2) application or anANDA for the same product for 3-years.• FDA can accept and review application during this period• Orphan Drug Exclusivity: 7 year protection on orphan drugs• Pediatric Exclusivity: 6-month extension to protection innovator alreadyhas

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