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  1. Clinical Trials

    a registry of federally and privately supported clinical trials conducted in the United States and around the world.
  2. FDA Listing of "Authorized" Generics

    an informative website
  3. First-Time Generics

    page where FDA reports provides monthly reports for First-Time Generics only.
  4. Intellectual Property Office- Journal Download

    Downloadable journals by publication week in a PDF format.
  5. Intellectual Property Office- Patents

    Patents pages of the IP professional section of the website including forms,online services and managing patents.
  6. Is it worth it for generics to challenge branded drugs

    an on-line summary of the patent challenge process which illustrates the points of view of all stakeholders.
  7. Orange Book On-Line

    updated daily and lists all commercial drug products (brand and generic) approved for safety and effectiveness in the United States together with dated patents relevant to the active drug substances as well as drug formulations, inert ingredients and uses.
  8. Paragraph IV Patent Certifications

    current list of Paragraph IV patent certifications received by the FDA Office of Generic Drugs (OGD). The list, updated twice monthly, includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the agency (on a prospective basis beginning 3/2/04).
  9. Waxman-Hatch Law

    an excellent summary of the legal precedents and current application of drug patent law in the interaction between the FDA, US Federal District Courts and the Court of Appeals for the Federal Circuit in determining drug marketing exclusivity periods. Provides excellent contextual definitions for terms including: Paragraph IV Certification; 45 day waiting period; thirty-month period; Bioequivalence; Substance, product, method of manufacture and method of use patents.
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