180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act

Description

This guidance is intended to provide industry with information on how the Food and Drug Administration (FDA) is applying the 180-day generic drug exclusivity provisions of the Federal Food, Drug, and Cosmetic Act (the Act) in light of recent court decisions. The guidance addresses the issue of the elimination of the "successful defense" requirement, which required an abbreviated new application (ANDA) applicant to be sued for patent infringement and to prevail in the litigation to receive the 180-day period of marketing exclusivity. This guidance will remain in effect until superseded by new regulations or new guidance.

Scope & Applicability

• 21CFR314.107§ 314.107 Date of approval of a 505(b)(2) application or ANDA.

  (a) General. A drug product may be introduced or delivered for introduction into interstate commerce when the 505(b)(2) application or ANDA for the drug product is approved. A 505(b)(2) application or ANDA for a drug product is approved on the date FDA issues an approval letter under § 314.105 for tRead full regulation →

• 21CFR314.95§ 314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent.

  (a) Notice of certification. For each patent that claims the listed drug or that claims a use for such listed drug for which the applicant is seeking approval and for which the applicant submits a paragraph IV certification, the applicant must send notice of such certification by registered or certiRead full regulation →

• 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (Status: Final)
• Good ANDA Submission Practices Guidance for Industry (Status: Final)
• Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (Status: Final)
• ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs: Guidance for Industry (Status: Final)
• Providing Regulatory Submissions in Electronic Format--Receipt Date: Guidance for Industry (Status: Final)