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While generic drugs that do not meet the sole source criteria in section 1860D-14B(g)(1)(C)(ii) of the Act (that is, multiple source generic drugs) are excluded from the definition of a Part D rebatable drug, CMS understands that a generic drug may meet the definition of a Part D rebatable drug on the first day of an applicable period and then cease to meet such definition later in the applicable period if, for example, the FDA approves another therapeutically equivalent generic drug under a 505(j) ANDA and that drug is marketed during such applicable period

10.14348/molcells.2016.2349 100 NodaT

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