Description
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day.” This guidance explains how FDA intends to determine eligibility for 180-day exclusivity when multiple substantially complete abbreviated new drug applications (ANDAs) that contain a paragraph IV certification to the same patent(s) are submitted on the same day or when paragraph IV certifications are submitted in an amendment or supplement on the same day.
Scope & Applicability
Stakeholders
4Submits new patents to FDA after issuance
Applicant eligible for 180-day generic drug exclusivity
Holder of the approved NDA
entity submitting marketing applications
Regulatory Context
Attributes
1ANDA will not be considered to be substantially complete when submitted
Related CFR Sections (2)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read 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 →
See Also (8)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- CPG Sec. 442.100 New Drugs - Export (Status: Final)
- CPG Sec. 400.325 Candy "Pills" Representation as Drug (Status: Final)
- CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines (Status: Final)
- CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations (Status: Final)
- CPG Sec. 450.300 OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination Products (Status: Final)
- CPG Sec. 400.500 Identical or Similar Product Names (Status: Final)