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Hatch-Waxman Review

To combat the rising costs of litigating Hatch-Waxman cases, XDD recently developed an internal Hatch-Waxman Division comprised of seasoned attorneys, project managers and technical experts who focus solely on helping pharmaceutical companies and outside counsel reduce time and costs associated to eDiscovery.

In parallel, we developed “BlackBar 2.0”, a proprietary Excel Native Redaction Tool that empowers users to redact and produce Microsoft Excel files in native format to dramatically minimize time, cost and errors.

Since inception, the XDD Hatch-Waxman team has successfully completed 150+ complex projects for clients.  To learn more about BlackBar or our Hatch-Waxman services, please contact us via our quick online form.


What is Hatch-Waxman?

  • Bill passed in 1984 that outlines the process for pharmaceutical manufacturers to file an Abbreviated New Drug Application (ANDA) for approval of a generic drug by the FDA
  • Generic drugs no longer need to prove their safety and efficacy
  • Generic drug manufacturers need only submit an Abbreviated New Drug Application (ANDA) to prove their product’s bioequivalence to the original branded drug
  • Since approved, the number of generic drugs available to consumers has increased exponentially
  • Branded drugs typically lose more than 40% of their market share to their generic counterparts

eDiscovery Implications

  • Exponential number of Hatch-Waxman cases filed annually
  • Discovery typically includes thousands of Excel documents
    • Multiple tabs
    • Multiple columns / rows
    • Multiple references to responsive data
  • Antiquated Excel discovery process is costly, time-consuming and prone to human error
  • Nearly impossible to print, align, find, redact and produce responsive data accurately

XDD Solution – BlackBar Excel Native Redaction Tool

  • Proprietary tool that empowers users to redact and produce Microsoft Excel files in native format to minimize time, cost and errors
  • Fully integrated into XDD Relativity review platform
  • Natively redacts XLS files within the tool
  • Optimizes traditional workflow productions
  • Produces newly redacted XLS files in Native File Format
  • Forever banishes the need to TIFF and print XLS files
  • Fully defensible process that tracks all actions
  • Adaptable design fits into different workflows seamlessly
  • Provides full administrative and redaction functions

XDD Hatch-Waxman Team

  • Dedicated Hatch-Waxman team comprised of seasoned attorneys, project managers and technical experts
  • Focus solely on helping pharmaceutical companies and outside counsel reduce time and costs associated to eDiscovery
  • Experts in using XDD BlackBar Excel Native Redaction Tool
  • Successfully completed 150+ complex projects for clients

Experience BlackBar Via Live Demo

To learn more about BlackBar or our Hatch-Waxman services, please contact us via our quick online form.

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