Description
The Food and Drug Administration (FDA or the Agency) is issuing this guidance to set forth a change in the Agency’s interpretation of the 5-year new chemical entity (NCE) exclusivity provisions as they apply to certain fixed-combination drug products (fixed-combinations). Historically, FDA has interpreted these provisions such that a fixed-combination was ineligible for 5-year NCE exclusivity if it contained a previously approved active moiety, even if the product also contained a new active moiety (i.e., an active moiety that the Agency had not previously approved). The Agency recognizes that fixed-combinations have become increasingly prevalent in certain therapeutic areas (including cancer, cardiovascular, and infectious disease) and that these products play an important role in optimizing adherence to dosing regimens and improving patient outcomes. As further discussed below, we are therefore revising our historical interpretation of the 5-year NCE exclusivity provisions to further incentivize the development of certain fixed-combination products.
Scope & Applicability
Product Classes
3Products typically containing a single drug substance
Drug product containing two or more active ingredients; Drug products containing multiple active ingredients
Two or more active ingredients combined at a fixed dosage
Regulatory Context
Attributes
2Certification of patent invalidity or noninfringement
A drug substance that contains no active moiety previously approved by FDA
Related CFR Sections (3)
- 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 →
- 21CFR210.3§ 210.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 , 225 , and 226 of this chapter .Read full regulation →
- 21CFR314.108§ 314.108 New drug product exclusivity.
(a) Definitions. The definitions in § 314.3 and the following definitions of terms apply to this section:Read 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)