U.S. Insights: Paragraph IV Litigation Decision Trends for Top 20 Generic Manufacturers, 2017–2023

Under U.S. law, a company that files an Abbreviated New Drug Application (ANDA) seeking FDA approval for a generic drug must submit a Paragraph IV (PIV) certification to “certify” against any patents that the brand manufacturer has listed in the FDA’s “Orange Book” database. If an ANDA filer submits a PIV certification, then the patent owner has an opportunity to sue the ANDA filer for patent infringement in an effort to block generic entry until patent expiration. Such lawsuits are often resolved by settlement agreements in which the generic manufacturer is permitted to enter the market on a mutually agreed-upon date. In some circumstances, however, the companies do not reach a settlement agreement and the lawsuit is litigated to a final decision.

IPD has released a new Data STACK report focused on trends in court decisions involving Paragraph IV (PIV) certifications that were litigated to a final decision over the last 5 years. The report features 273 certifications that IPD reviewed and analyzed from the top 20 generic manufacturers that litigated the most PIV certifications to a final decision, from January 2017 through October 2023. Our Data STACK report dives into trends by manufacturer, jurisdiction, and patent type to reveal key themes that can help predict outcomes with greater certainty.