Opportunity map
Months to window vs annual market size, sized by score
Generic & biosimilar opportunity map
Months to window vs annual market size, sized by score
What’s Lapse?
Which drugs should a generic manufacturer file on next. Ranked, off public data.
Between 2025 and 2030, branded drugs worth an estimated $200B+ in annual sales lose patent protection. Generic and biosimilar makers have to decide which of those drugs to pursue with limited resources, and today they do it by hand, stitching together government databases.
Lapse turns that manual research into a ranked, scored intelligence layer. It joins FDA Orange Book, FDA Purple Book, CMS Medicare Part D and Part B spending data, openFDA Drugs@FDA ANDA signals, openFDA Drug Labeling descriptions, and biosimilar competition signals, then scores small molecules and biologics in one cross-modality opportunity table.
Generic and biosimilar makers, business-development teams, portfolio strategy teams, and analysts deciding which branded drugs to pursue with limited resources.
Small molecules are chemically made drugs with relatively simple, well-defined structures. When protection expires, competitors usually pursue conventional generics through ANDA filings.
Biologics are larger, more complex medicines made from living systems, often proteins or antibodies. Because they are harder to copy exactly, follow-on competitors are biosimilars or interchangeables rather than standard generics.
Lapse keeps these categories separate because their market sizes, regulatory paths, and competition patterns behave differently.
The final opportunity score blends market size, timing, match quality, and competition. Higher is better.
Scores are deterministic SQL — identical inputs always give identical ranks, and any run can be pinned to an exact as-of date for reproduction. No model or randomness touches a score.
Every run gates on 230+ data-quality checks, including revenue-conservation checks (summed market sizes reconcile to CMS totals), match-rate guards, and score-range checks.