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If a PMTA application is filed with the FDA during this 24-month period, then the manufacturer can continue to market its products unless and until the FDA responds to the application

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CMS intends to apply this unit exclusion at the month level and would exclude all units of a generic drug that ceases to meet the definition of a Part D rebatable drug beginning with the first day of the first month when a therapeutically equivalent drug approved under a 505(j) ANDA is marketed based on the marketing start date in the NDC Directory or when the reference listed drug, or an authorized generic of the reference listed drug is marketed based on the marketing start date in the NDC Directory

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Retrieved June 1, 2022