Orphan Drug Exclusivity (ODE) ' FDA Continues Its Attack

• Published date: 30 June 2023
• Law Firm: Oblon, McClelland, Maier & Neustadt, L.L.P
• Author: Mr Richard D. Kelly

Orphan drug exclusivity was created in 1983 to encourage pharmaceutical companies to develop drugs for diseases which affect less than 200,000 persons in the U.S. Jazz Pharmaceuticals developed Xwav^' to treat narcolepsy, a rare sleep disorder characterized by excessive daytime sleepiness and cataplexy, voluntary muscle weakness. Xywav^' received orphan drug exclusivity until July 2027 when it expires. Xywav^' comprises the drug oxybate as mixed salts of calcium, magnesium, potassium, and sodium oxybate. The Orphan Drug Act 21 U.S.C. 360 cc (b) provides the exclusivity can be broken if:

(1) The exclusivity holder cannot meet the needs of the persons with the condition; or

(2) The exclusivity holder provides written consent to the FDA to issuing additional licenses for the drug;

A drug with an existing...