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  • 1.  ODA exclusivity if off-patent

    Posted 19-Mar-2015 11:45
    Can a drug that is already off-patent in fact still qualify for market exclusivity if it receives orphan status under ODA?

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    Christopher Shilling
    Columbus OH
    United States
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  • 2.  RE: ODA exclusivity if off-patent

    Posted 20-Mar-2015 08:02
    Hi Chris-
    Yes, the drug would receive market exclusivity for the indication under orphan status - BUT understand that the drug could marketed as a generic with a label that carves-out the the orphan indication. So even though the NDA holder has the market exclusivity, it is basically an approval that has no overall benefit.

    You can see the recent issues around Reclast and their approval for Paget's Disease, and yet the drug was widely used for osteoporosis. The generic companies carved out the Paget's indication, and only included the osteoporosis indication.

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    Shannon Wehrendt MA
    Senior Labeling Coordinator
    West-Ward Pharmaceuticals
    Eatontown NJ
    United States
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    Original Message


  • 3.  RE: ODA exclusivity if off-patent

    Posted 23-Mar-2015 08:12
    Hi Chris.

    I assume you are aware  Shannon's comment here - just because there is a required "label carve-out" for your new exclusive indication does not impact generic substitution at the pharmacy just because FDA has granted you market exclusivity on the indication.  Provided that the drugs have an equivalent therapeutic rating by FDA most states allow (if not require) that the pharmacist fill the Rx with generic product and most insurance companies will also expect the generic to be used if it is available.  So from a technical point of view, your exclusivity is really useless in this situation since it will likely not revitalize the franchise that has gone off patent.  This is, of course, different if you can convince a significant number of medical providers/prescribers to DAW your product on the Rx but your patients will likely be upset by the fact that their insurance either won't cover the costs and they will be responsible for full payment or the insurers will charge the highest tiered copay for the drug....

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    Victor Mencarelli
    Sr. Manager - Regulatory Affairs
    United States
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    Original Message


  • 4.  RE: ODA exclusivity if off-patent

    Posted 20-Mar-2015 10:50
    yes. it can still quality.  orphan exclusivity as well as Waxman-Hatch exclusivity can be awarded regardless of patent statusd

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    Michael Hamrell, Ph.D., RAC, FRAPS
    MORIAH Consultants
    Huntington Beach CA
    United States
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    Original Message