FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Otsuka Loses Again in Challenge to FDA Green Light for Competing Drug

Sept. 13, 2017

A federal appeals court rejected a challenge by Otsuka Pharmaceuticals to the FDA’s decision to deny exclusive marketing rights to Otsuka’s antipsychotic injectable Abilify Maintena vis-a-vis a competing antipsychotic drug.

The ruling by the U.S. Court of Appeals for the District of Columbia Circuit upheld a lower court ruling against Otsuka. The appeals court found that the FDA acted reasonably when it rejected Otsuka’s claim to exclusivity on the grounds that the competing drug, Alkermes’ Aristada, relies on a different active ingredient for its effects.

To foster competition, federal law allows drug developers to piggyback on research conducted by other drug companies in seeking approval of similar medications. But to deter “free riders” and protect the inventor of the original drug, the law allows for periods of marketing exclusivity for the original product.

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