Patent and Exclusivity Issues
{"Image DocumentName": "Patent and Exclusivity Issues", "Image ImageDescription": "Waxman-Hatch Exclusivities block ANDAs and 505(b)(2) NDAs, but cannot block a full NDA. 3-year exclusivity blocks other pending 505(b)(2)s, regardless of filing date; creates race to approval. Only the first 505(b)(2) for a change can receive exclusivity. Studies for later applications deemed not essential for approval \u2013 because an ANDA would be possible. 5-year exclusivity does not block other 505(b)(2)s that were filed before first approval.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}