Here are some helpful tips and reminders regarding ANDA submissions, patent certification requirements, notice requirements and a couple of Orange Book gems. Please note that not all requirements are listed, and that this just highlights some of the issues discussed.

  • Later listed patents after ANDA submission but before approval must be addressed if the patent is submitted in a timely manner. A timely filed patent is one that is submitted for listing by the NDA holder within 30 days of issuance of the patent, or within 30 days after approval of an innovator labeling change that relates to the patent.
  • A newly approved use of a product where the same patent is referenced and the new use is certified as being covered by that patent, must be addressed by the ANDA applicant as it relates to the newly approved use of the innovator product. The ANDA applicant must submit an appropriate patent certification or little viii statement if a PIV certification is made in regard to the new use. The ANDA applicant must provide notice and evidence of notice to its application, however, there is no 30-month stay of approval for the ANDA in that instance.
  • Note that documentation of the date the notice is sent to the innovator is confirmed by a copy of receipts of certified mail, registered mail or a designated delivery service. Receipt of the notice by the innovator is required to be by return receipt, signature of proof of delivery by a designated delivery service or a letter acknowledging receipt of the by the person provided the notice.
  • The notice of receipt must contain a signature proof of delivery and document the address to which the notice was delivered and name of the individual that received the notice.
  • Notice must be provided to FDA within 14 days of legal action filed with 45 days of receipt of the PIV notice along with information regarding the suit.
  • Notify the Agency if no legal action is taken within the 45-day period after notice by submission of an amendment to the ANDA.
  • There is a requirement to submit final court actions within 14 days. If a licensing agreement is reached, the applicant should file a statement under 21 CFR 314.94(a)(12)(v).
  • Notice of first commercial marketing for 180-day patent challenge exclusivity must be made to the FDA by a first applicant within 30 days of initial marketing. For 180-day Generic Competitive Therapy (GCT) Exclusivity the first applicant must begin commercial marketing with 75 days of approval, if not the exclusivity is forfeited. You certainly don’t want that to happen! To safeguard your eligibility for the 180-day GCT exclusivity, it is suggested to provide notice of the date of first marketing be made to the FDA on the first available date of marketing. Remember that other ANDAs can still be approved prior to the award of CGT exclusivity. GCT only blocks subsequent applications from approval until the 180-day period is over.
  • Patents are published in the Orange Book daily. Approvals are also published daily.
  • Proprietary names changes are listed in the Orange Book only after a supplement is approved for the new name. [Author’s note – Remember that FDA does not approve distributor labeling or trade names associated with those used by a distributor, but that is a whole other story!]

The information addressed in this post covers a certain number of the key topics covered in various Agency presentations. Please use these tidbits recognizing that they may not fully address a scenario you are experiencing and be certain to use other available FDA information and guidances to assure you have the complete and necessary information.