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# CDER Explains MorphaBond Exclusivity
- URL: https://www.fdaweb.com/cder-explains-morphabond-exclusivity/
- Published: 2017-02-15T12:00:00.000Z
- Updated: 2026-09-14T22:06:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137988

The CDER Exclusivity Board says that the scope of Daiichi Sankyo’sMorphaBond’s three-year exclusivity is labeling describing the expected reduction of abuse of single-entity extended-release morphine by the intranasal route of administration due to physiochemical properties. In a just-released [determination](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM540646.pdf?ref=fdaweb.com), the board says the exclusivity expires 10/2/18.

MorphaBond (morphine sulfate), the document says, is the first FDA-approved, single-entity, morphine product with claims in the labeling related to deterring abuse via the intranasal and intravenous routes.

The board assessed the scope of MorphaBond’s exclusivity in light of a pending action for an application for another morphine sulfate extended-release tablet product with abuse deterrence claims in the proposed labeling. As part of its determination, the board recommended that the *Orange Book* be amended to describe the MorphaBond exclusivity code as “M-XXX, labeling describing the expected reduction of abuse of single-entity extended-release morphine by the intranasal route due to physiochemical properties.”