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# FDA Explains Morphabond Exclusivity Determination
- URL: https://www.fdaweb.com/fda-explains-morphabond-exclusivity-determination/
- Published: 2017-02-23T12:00:00.000Z
- Updated: 2026-09-14T22:08:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138048

A CDER Exclusivity Board memorandum explains the reasoning the agency followed in determining the scope of three-year exclusivity for Inspirion Delivery Technologies’ Morphabond (morphine sulfate) extended-release tablets. Attorney **Kurt Karst** (Hyman, Phelps & McNamara) [writes](http://www.fdalawblog.net/fda%5Flaw%5Fblog%5Fhyman%5Fphelps/2017/02/fda-opines-on-the-scope-of-3-year-exclusivity-for-morphabond-.html?ref=fdaweb.com) in his firm’s *FDA Law Blog* that the memo “details FDA’s decision-making process on how to handle abuse-deterrence more generally” in addition to the Morphabond specifics.

The board determined that Morphabond exclusivity should protect the labeling claim that it is expected to reduce abuse of single-entity extended release morphine by the intranasal route of administration due to physiochemical properties. Thus, Karst writes, the scope of exclusivity is defined by two primary characteristics — the abuse route and the type of abuse deterrence employed. He notes that the Waxman-Hatch statute does not expressly describe the scope of exclusivity for three-year exclusivity, giving the agency discretion to make such determinations in a manner consistent with the statutory language and the intent of Congress. In making its decision, he says, the board considered and rejected both broader and narrower approaches to the scope of exclusivity.