FTC calls out Jazz Pharma's abuse of FDA Orange Book listing process
The Federal Trade Commission is calling to keep strict statutory limits on Orange Book patent listings, explaining in an amicus brief yesterday that patents related to REMS distribution systems should not block generic or other competition.
The case at hand involves Avadel CNS Pharmaceuticals, which has sought to delist one of Jazz Pharmaceuticals’ patents related to the method for distributing its blockbuster narcolepsy drug Xyrem as part of a restricted distribution system under its REMS.
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