ANDA What type of patent and/or exclusivity protection is a 505(b) (2) application eligible for
{"Image DocumentName": "ANDAWhat type of patent and/or exclusivity protection is a 505(b) (2) application eligible for?", "Image ImageDescription": "Granted 3 years of Waxman-Hatch exclusivity if one or more of the clinical investigations other than BA/BE studies was essential to approval of the application and was conducted or sponsored by the applicant (21 CFR (j); (b)(4) and (5)). Granted 5 years of exclusivity if it is for a new chemical entity (21 CFR (j); (b) (2)). Eligible for orphan drug exclusivity (21 CFR ) or pediatric exclusivity (section 505A of the Act).", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}