On June 18, 2019, the FDA announced plans to expand its Paragraph IV Patent Certifications List, a database used to list information about applications for generic drug approval. The changes are part of the FDA’s on-going efforts “to provide the industry with greater transparency in order to provide greater certainty around timing of market entry and empower more informed decisions on how to prioritize [generic drug makers’] resources.” FDA Statement (June 18, 2019).
Prior to the expansion, the database included the drug product name, dosage form, strength, referenced listed drug (RLD) or new application number (NDA), and the date on which the first substantially completed ANDA was submitted to the Agency with a paragraph IV certification. The database will now also include (1) the number of potential first applicant ANDAs submitted, (2) whether the FDA has made or deferred a decision regarding eligibility for 180-day exclusivity for a drug product, (3) the date a first applicant’s ANDA received final approval, (4) the date of first commercial marketing, and (5) the expiration date of the last qualifying patent.
The expansion is intended to help generic drug makers understand how many other ANDA applicants are seeking marketing approval, allowing them to make more informed decisions about whether to pursue a generic drug product. The new information may also help signal abuse of the 180-day exclusivity period by delaying entry into the market. The agency’s decision to increase transparency surrounding the 180-day exclusivity period aligns with the government’s increasing focus on lowering drug costs.