Add a comment
  • Kristabelle on 2016-Jul-18 12:02:10 Kristabelle said

    Dear Shamnad,There is an option to file ANDA during the term of patent under the Hatch Waxman Act. A generic company may file an ANDA under Para 3 certification during the term of the patent. The FDA would accept the application and take it for reawii/exvmenation but will not approve the ANDA till the patent term expires (i.e. FDA will give only a tentative approval). ANDA filing with para 3 certification would not trigger litigation.

Photo info

Popular tags