Market Exclusivity for 'novel' biological drug productsExclusivity 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 abbreviated new drug applications (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.
Under the Inflation Reduction Act (IRA), brand-name and biologic drugs without generic or biosimilar equivalents covered under Medicare Part D (retail prescription drugs) or Part B (administered by physicians) are provided exclusivity for nine (small-molecule drugs) or 13 or more years (biologicals) from the time of FDA approval. After this period of exclusivity brand-name and biologics are subject to generic or biosimilar equivalents competition and drug price reduction.