Expanding Access to Low-Cost Generics Act of 2023

This bill creates a new pathway for generic drug manufacturers to enter the market faster under specific conditions. It allows subsequent applicants to receive "effective approval" 180 days after a first applicant begins marketing a drug, but only if 33 months have passed since the first application and the first applicant hasn't started marketing within 75 days of approval. If a subsequent applicant fails to begin marketing within 75 days of approval, their application reverts to "tentative approval" and they lose eligibility for that pathway unless they prove an unforeseen event prevented marketing. The bill directly affects generic drug manufacturers seeking FDA approval for drugs where a first applicant has delayed commercialization.