Structured monitoring of FDA drug patent and exclusivity data from public sources
HW App organizes publicly available regulatory and patent information into a single reference interface, allowing practitioners to monitor loss-of-exclusivity timelines, patent listings, litigation activity, and related developments across the FDA Orange Book and other official sources — without manually cross-referencing multiple government databases.
Registration is required for access during this early evaluation period.
Capabilities
Each FDA application has a consolidated page displaying its listed patents (classified by type), exclusivity periods, approval history, calculated LOE estimate, Paragraph IV filer activity, PTAB proceedings, litigation cases, SEC-reported revenue, Medicare spending data, clinical trials, and related news — drawn entirely from public records.
The platform tracks patent listings and exclusivity codes across the full Orange Book, identifies upcoming expirations, and flags changes such as new listings, delistings, or code modifications on a daily basis.
Hatch-Waxman cases (NOS 835) from PACER, IPR/PGR proceedings from the USPTO, and ITC Section 337 investigations from the USITC are indexed and associated with the relevant drug applications and Orange Book patents where matches can be identified from public filings.
Paragraph IV certifications, citizen petitions filed under 21 CFR 314.93 and section 505(q), FDA approval letters, and Federal Register notices are collected and organized by drug and applicant.
When data changes across any monitored source — a patent delisted, a new PTAB proceeding filed, a generic application approved — the platform identifies the change and can deliver a notification summarizing what was modified.
Structured browse views allow filtering and sorting across patent cliffs, NCE expirations, biologics and biosimilars, therapeutic areas, company portfolios, drug pricing, clinical trials, and other dimensions. All views support CSV export for offline use.
Public Data Sources
All data is drawn from publicly available federal sources. The platform collects, structures, and cross-references records from the following agencies and databases on a recurring basis.
FDA Orange Book
Patent listings, exclusivities, products
Drugs@FDA
Approvals, submissions, labels, marketing status
USPTO PTAB
IPR, PGR, CBM proceedings and patent families
Patent Reexaminations
USPTO ex parte and inter partes proceedings
Regulations.gov
FDA citizen petitions (505(q), suitability)
News & Federal Register
20+ pharma RSS feeds, Federal Register, Google News
SEC EDGAR
10-K/10-Q filing intelligence, 8-K events, XBRL revenue
ClinicalTrials.gov
Active and recently updated trials by ingredient
NADAC Pricing
Pharmacy acquisition costs per NDC
Purple Book
Licensed biologics, biosimilars, interchangeables
VA FSS Pricing
Government-negotiated drug prices
Medicare Part D
Drug spending, claims, beneficiaries
Medicare Part B
Physician-administered drug spending and ASP pricing
PACER
Hatch-Waxman ANDA litigation (NOS 835)
FDA Paragraph IV PDF
Paragraph IV certifications
USITC IDS
ITC Section 337 investigations, patents, orders
openFDA API
Drug enrichment, labels, NDC crosswalk
Access
HW App is in an early refinement phase. Access is available by registration to allow for structured evaluation and feedback. If you would like to review the platform, please request an account below.
HW App is not a law firm and does not provide legal advice or engage in the practice of law. Access to or use of this platform does not create an attorney-client relationship. The platform is intended as an informational reference and data-organization tool. It is not a substitute for independent legal analysis, regulatory advice, or professional judgment. Calculated dates and automated associations are derived algorithmically from public records and should be independently verified for any matter-specific use.
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