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Testing version — LOERadar is in active testing. Features and data may change.

FDA regulatory & patent intelligence

Loss-of-exclusivity intelligence, drawn from the public record.

LOERadar consolidates FDA drug patent listings, exclusivity periods, Hatch-Waxman litigation, and LOE timelines from seventeen public sources into one research interface — so practitioners stop cross-referencing the Orange Book, PTAB, PACER, and SEC filings by hand.

Sponsored byPolsinelli
LOERadar
LOERadarLOERadar · Drug detail
Illustrative example

Apixaban

Eliquis®

Bristol-Myers Squibb · NDA 202155 · Oral tablet

6Orange Book patents3exclusivitiesParagraph IV filed
Exclusivity timeline
LOE 2031
Formulation patent (+ PED)
Method-of-use patents
Compound patent
20242026202820302032
Estimated loss of exclusivityFeb 2031
29,000+
FDA applications indexed
17
public data sources
Daily
Orange Book change monitoring
25+
intelligence dashboards

Coverage reflects the public record. Calculated dates and loss-of-exclusivity estimates are algorithmically derived and should be independently verified.

The single pane of glass

Everything one drug touches, on one page.

The data professionals already cross-reference by hand — the Orange Book, Drugs@FDA, PTAB, PACER, ClinicalTrials.gov, Medicare pricing, and SEC filings — collected, structured, and linked together.

01

Drug-level reference pages

Each FDA application has one consolidated page: listed patents classified by type, exclusivity periods, approval history, Paragraph IV activity, PTAB proceedings, litigation, SEC-reported revenue, Medicare spending, clinical trials, and related news — all from public records.

02

Patent & exclusivity monitoring

The platform tracks patent listings and exclusivity codes across the full Orange Book, identifies upcoming expirations, and flags changes — new listings, delistings, or code modifications — on a daily basis.

03

Litigation & PTAB tracking

Hatch-Waxman cases (NOS 835) from PACER, IPR/PGR proceedings from the USPTO, and ITC Section 337 investigations are indexed and associated with the drug applications and Orange Book patents they touch.

04

Regulatory filing activity

Paragraph IV certifications, citizen petitions under section 505(q), suitability petitions under 21 CFR 314.93, FDA approval letters, and Federal Register notices are collected and organized by drug and applicant.

05

Change detection & alerts

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 moved.

06

Searchable browse views

Structured views filter and sort across patent cliffs, NCE expirations, biologics and biosimilars, therapeutic areas, company portfolios, drug pricing, and clinical trials. Every view supports CSV export.

Public sources only

Built entirely on the public record.

Every record is drawn from publicly available sources, collected and cross-referenced on a recurring schedule.

Daily

FDA Orange Book

Patent listings, exclusivities, products

Daily

Drugs@FDA

Approvals, submissions, labels, marketing status

Daily

USPTO PTAB

IPR, PGR, CBM proceedings and patent families

Daily

Patent Reexaminations

USPTO ex parte and inter partes proceedings

Daily

Regulations.gov

FDA citizen petitions (505(q), suitability)

Daily

News & Federal Register

20+ pharma RSS feeds, Federal Register, Google News

Daily

SEC EDGAR

10-K/10-Q intelligence, 8-K events, XBRL revenue

Daily

ClinicalTrials.gov

Active and recently updated trials by ingredient

Weekly

NADAC Pricing

Pharmacy acquisition costs per NDC

Weekly

USITC IDS

ITC Section 337 investigations, patents, orders

Bi-weekly

FDA Paragraph IV

Paragraph IV certification listings

Monthly

Purple Book

Licensed biologics, biosimilars, interchangeables

Monthly

VA FSS Pricing

Government-negotiated drug prices

Annual

Medicare Part D

Drug spending, claims, beneficiaries

Annual

Medicare Part B

Physician-administered drug spending and ASP

On-demand

PACER

Hatch-Waxman ANDA litigation (NOS 835)

On-demand

openFDA API

Drug enrichment, labels, NDC crosswalk

Polsinelli

LOERadar is supported by the Polsinelli Hatch-Waxman, Biologics/Biosimilars, and Life Sciences practices.

Attorney Advertising

LOERadar is an informational research and data-organization tool. It is not a law firm and does not provide legal advice or engage in the practice of law, and access to or use of the platform does not create an attorney-client relationship with Polsinelli PC or any other person. Polsinelli’s sponsorship of this tool does not constitute legal advice or a solicitation, and nothing here should be relied upon as a substitute for independent legal analysis, regulatory advice, or professional judgment. All data is aggregated from publicly available sources; LOERadar is not affiliated with, endorsed by, or sponsored by the FDA, USPTO, or any government agency. Calculated dates, loss-of-exclusivity estimates, and automated associations are derived algorithmically from public records, may contain errors or omissions, and should be independently verified before being relied upon for any matter-specific purpose.

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