JAZZ PHARMACEUTICALS, INC. v. BECERRA et al

Track this case

Case Number:

1:23-cv-01819

Court:

District Of Columbia

Nature of Suit:

Administrative Procedure Act/Review or Appeal of Agency Decision

Judge:

Firms

Companies

Jazz Pharmaceuticals Inc.

Government Agencies

Sectors & Industries:

Healthcare
- Biotechnology

May 10, 2024
Pharma Cos., FDA Debate 'Same Drug' In Orphan Drug Case

Two pharmaceutical companies and the U.S. Food and Drug Administration faced off in D.C. federal court Friday over allegations that the federal agency wrongly approved a treatment that rivals Jazz Pharma's narcolepsy drug despite Jazz's exclusivity rights under the Orphan Drug Act.
June 22, 2023
Jazz Pharma Says FDA Again Defied Orphan Drug Exclusivity

Jazz Pharma on Thursday asked a D.C. federal judge to block the U.S. Food and Drug Administration's "unlawful" approval of a rival narcolepsy treatment despite Jazz's exclusivity rights under the Orphan Drug Act, arguing that it showcases the FDA's "stark refusal" to implement the ODA as it should.