Ann: IHL Provides Shareholder Information Events for Redomiciling, page-325

New Chemical Exclusivity (NCE) - 5 years:
• Granted to a drug that contains no active moiety that has been approved by FDA under section 505(b)
• Runs from time of NDA approval
• Bars FDA from accepting for review any ANDA or 505(b)(2) application for a drug containing the same active moiety
for:
- five years if an ANDA or 505(b)(2) does not contain a paragraph IV certification to a listed patent
- four years if an ANDA or 505(b)(2) is submitted containing a paragraph IV certification to a listed patent
• Described in 21 CFR 314.108

3. "Other" Exclusivity - 3 years for a "change" if criteria are met:
• Granted to drug when application or supplement contains reports of new clinical investigations (not bioavailability
studies) conducted or sponsored by applicant and essential for approval
• Runs from time of NDA approval
• Bars FDA from approving, for a three year period, any ANDA or 505(b)(2) application that relies on the information
supporting the approval of the drug or the change to the drug for which the information was submitted and the
exclusivity granted
• Described in 21 CFR 314.108