The following may be of interest to those unfamiliar with the...

The following may be of interest to those unfamiliar with the exclusivity rights that flow from FDA approval independent of patent protection:

“Exclusivity.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. It prevents the submission or effective approval of ANDAs or applications described in Section 505(b)(2) of the Act, and was designed to promote a balance between new drug innovation and generic drug competition.

Exclusivity is granted upon approval of a drug product if the statutory requirements are met. The length of time that FDA grants new drug exclusivity depends on the type of exclusivity. Note that exclusivity is not added to the patent life. Hatch Waxman exclusivity (5-year, 3- year, and 180-day) is described in 21 C.F.R. 314.108. There are four types of exclusivity that fall under the NDA statutory requirements:

1. Orphan Drug Exclusivity (ODE) - 7 years:• Granted to drugs designated and approved to treat diseases or conditions affecting fewer than 200,000 in the U.S. (ormore than 200,000 and no hope of recovering costs)• Runs from time of approval of NDA or BLA• Bars FDA from approving any other application (ANDA, 505(b)(2) or “full” NDA or BLA) for the same drug for thesame orphan disease or condition for seven years• Covered under the Orphan Drug Act and 21 CFR 316.31

2. 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 bioavailabilitystudies) 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

4. Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity• Grants an additional 6 months of market protection at the end of listed patents and/or exclusivity for sponsor’s drug products containing the active moiety, when the sponsor has conducted and submitted pediatric studies on the active moiety in response to a Written Request from FDA• Pediatric exclusivity takes on characteristics of five year, three year or orphan exclusivity when it attaches to those protections.• Described in the Best Pharmaceuticals for Children Act (BCPA) and Section 505(A) of the Food and Drug Administration Modernization Act of 1997.

My opinion only DYOR

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