Innovator Multiple Source Drugs definition

Innovator Multiple Source Drugs will have the same meaning as set forth in 42 U.S.C. §1396r- 8(k)(7)(A)(ii), et seq., and will include all Covered Outpatient Drugs approved under a New Drug Application (NDA), Product License Approval (PLA), Establishment License Approval (ELA), or Antibiotic Drug Approval (ADA). A covered outpatient drug marketed by a cross- licensed producer or distributor under the approved NDA will be included as an innovator multiple source drug when the drug product meets this definition.
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Examples of Innovator Multiple Source Drugs in a sentence

  • For all of its Single Source Drugs and Innovator Multiple Source Drugs that are Government Reimbursed Products, Mallinckrodt shall provide the IRO with a listing of the Medicaid rebate eligible NDCs (at the NDC-9 level) for which Mallinckrodt paid Medicaid rebates during the Reporting Period.

  • Only for Single Source and Innovator Multiple Source Drugs, otherwise zero fill.

  • In the event that the Manufacturer/Labeler has paid rebates for Single Source Drugs or Innovator Multiple Source Drugs using the CPI-U Factor pursuant to a prior CHIP drug rebate agreement with HHSC, then the Manufacturer/Labeler will be entitled to recalculate these rebates and deduct the overpayment from future Rebate Payments to HHSC.

  • More specifically, the IRO shall review (i) all NDCs for Government Reimbursed Products that are Single Source Drugs or Innovator Multiple Source Drugs; and (ii) any NDCs for Government Reimbursed Products that are Non-Innovator Multiple Source Drugs.

  • For all of its Government Reimbursed Products that are Single Source Drugs and Innovator Multiple Source Drugs Mallinckrodt shall provide the IRO with a list of all Mallinckrodt customers who purchased or contracted for those products during the Reporting Period (Selected Customers).

  • In the event that the Manufacturer/Labeler has paid rebates for Single Source Drugs or Innovator Multiple Source Drugs using the CPI-U Factor pursuant to a prior CSHCN drug rebate agreement with HHSC, then the Manufacturer/Labeler will be entitled to recalculate these rebates and deduct the overpayment from future Rebate Payments to HHSC.