Hub

Browse all FDA Orange Book products, patents, and exclusivities. Search by drug name, applicant, or application number.

Browse FDA-licensed biological products: reference products (351(a)), biosimilars (351(k)), and interchangeable biosimilars.

Browse drugs with patents expiring soon. Filter by time horizon and Paragraph IV / PTAB activity.

Track upcoming New Chemical Entity (NCE) exclusivity expirations. Identify when 5-year market protection ends and generic competition can begin.

NDA drugs with no Orange Book patents and no marketed generic equivalents.

Pre-publication ANDAs and NDAs found in litigation complaints before they appear in official FDA data.

Patents discovered via PatentsView API for Purple Book biologics. AI-classified by category and relevance to specific products.

Browse drugs grouped by Established Pharmacologic Class (EPC). Search or filter A-Z to explore drug classes.

Browse drugs by dosage form: tablets, injectables, capsules, solutions, and more. Filter by category and search within.

Browse active pharmaceutical ingredients and applicants alphabetically, with NDA/ANDA application counts for each.

Browse pharmaceutical companies by drug portfolio, patent position, and market presence.

Per-drug revenue extracted from SEC EDGAR filings (10-K, 20-F). Browse by company, sort by revenue, and track year-over-year growth.

Filing intelligence and corporate events from SEC EDGAR. Browse LOE disclosures, settlement terms, litigation updates, and 8-K events.

Track ANDA patent litigation cases across federal courts. Filter by status, court, and filing year.

Section 337 patent infringement investigations at the International Trade Commission involving pharma companies. Matched to products via patents.

Browse IPR, PGR, and patent reexamination proceedings challenging Orange Book patents. Track institution decisions, outcomes, and linked drugs.

FDA citizen petitions (505(q), suitability) that delay or affect generic drug approvals. AI-summarized.

Browse FDA approval letters for ANDA (generic drug) applications. Links to original letter PDFs.

Top drugs by Medicare spending and cost trends. Identify outliers and year-over-year changes.

Physician-administered drug spending (infusions, injections, biologics). Includes HCPCS codes and Average Sales Price (ASP).

Browse government-negotiated drug prices from the VA Federal Supply Schedule, including FSS, Big4, and National Contract rates.

National Average Drug Acquisition Cost data from Medicaid. Browse weekly acquisition costs for brand, generic, and OTC drugs.

Clinical trials for Orange Book drugs. Filter by phase, status, and sponsor.

Browse FDA Drug Master Files (DMFs). Track API suppliers, identify supply chain risks, and detect new generic competition signals.