FDA remains silent on orphan drug exclusivity after last year’s court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

“These sponsors cannot even be certain that their orphan-designated products will be protected by orphan exclusivity, because FDA’s OOPD has effectively stopped making exclusivity determinations since late 2021. The agency appears to be seeking to avoid having to recognize an orphan exclusivity broader than a product’s approved…
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