FDA Proposed Rule to Revise Hatch-Waxman Regulations

The proposal also revises the declaration that must be submitted in conjunction with an NDA application. The proposed declaration is more detailed than the one required under current regulations and is designed to prevent NDA applicants and NDA holders from attempting to list inappropriate patents. As part of the requirement for submitting this declaration, the NDA holder must confirm that an ANDA application containing the same active ingredient that is claimed by the listed patent is the "same" for ANDA approval purposes.

¹ The proposal further defines "active ingredients" to include compounds that are considered "the same as" the active ingredient based on, for example, solubility, stability, and bioavailability. According to the proposed regulations "active ingredients" include different forms of a drug substance, i.e. anhydrates, hemihydrates, dehydrates and different polymorphs (different crystalline forms of the same substance).

² The FDA's proposed regulations do not address "double patenting" patents.