Methodology
Data sources
The Phase 1 MVP combines FDA Orange Book product and patent files with ClinicalTrials.gov trial activity. USPTO and SEC modules are present as future enrichment stubs only.
Candidate filtering
The watchlist prioritizes NDA products that are reference listed drugs or reference standards, have listed patent coverage, and fall inside a conservative near-term expiry screen.
Patent-expiry window
The current near-term window centers on listed patent expiry patterns roughly 18 to 36 months out, while still preserving wider context for records 12 to 48 months away.
Clinical-trial matching
Trial linking is deterministic and based on brand, ingredient, and text evidence. It may miss code names, synonyms, combination therapies, and indication-only nuance.
Scoring
Expiry attractiveness, patent complexity (0–5), and clinical competition (0–5) are calculated separately so users can inspect the reasons behind each screening signal.
Confidence labels
High confidence requires Orange Book product and patent support, valid parsed dates, completed trial search, and at least one high-confidence trial link. Lower confidence reflects missing or ambiguous evidence.
Limitations
Orange Book patents are sponsor-submitted. Patent dates may include extensions as submitted. Trial matching may miss code names, synonyms, and combination therapies. The product does not determine freedom to operate. The product does not predict exact generic launch timing. Manual expert review is required for commercial decisions.
Not legal advice
This product is an intelligence screening tool. It does not provide legal advice, freedom-to-operate opinions, or generic-launch recommendations. Patent and exclusivity interpretation requires qualified legal review.