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DaubersUP

08/12/18 4:54 PM

#236943 RE: DaubersUP #236942

In addition to representing a faster, less expensive path to market, products approved under the 505(b)(2) pathway can also sometimes qualify for several types of market exclusivity such as orphan drug exclusivity (seven years), new chemical entity exclusivity (five years), “other” exclusivity (three years for a “change” if certain criteria are met), and pediatric exclusivity (six months added to existing patents/exclusivity).



Let’s hope for 7 additional years!