Failure-to-Market Forfeiture Mobile App

This app provides critical information and answers you need about the Hatch-Waxman Act’s provisions for failure-to-market forfeiture of 180-day exclusivity. Features include:

  • Guides you through a failure-to-market forfeiture analysis under the Hatch-Waxman Act 
  • Simplifies the analysis from the cumbersome and complex statutory language, providing immediate results informing whether there has been a FTM forfeiture, and enabling users to be prepared with ready answers while on the go 
  • Gives you a convenient, quick-reference tool, appropriate for both seasoned lawyers and law students



This app reflects our guide for considering a failure-to-market forfeiture under the Hatch-Waxman Act, 21 U.S.C. § 355(j)(D)(i)(I). The statutory language, case law, and FDA interpretations should be consulted carefully before any decision-making concerning potential or actual forfeitures. This app also is only considering the failure-to-market forfeiture. The Hatch-Waxman Act, 21 U.S.C. § 355(j)(D), includes other bases for forfeiture that should also be considered.