orphan-drug-act
2 cases — ← All topics
| Case | Title | Lower Court | Docketed | Status | Flags | Tags | Question Presented |
|---|---|---|---|---|---|---|---|
| 25A304 | Jazz Pharmaceuticals, Inc. v. Robert F. Kennedy, Secretary of Health and Human Services, et al. | District of Columbia | 2025-09-16 | Presumed Complete | administrative-law chevron-deference fda-regulation market-exclusivity orphan-drug-act statutory-interpretation | Question not identified. | |
| 21-1342 | Jacobus Pharmaceutical Company, Inc. v. Catalyst Pharmaceuticals, Inc., et al. | Eleventh Circuit | 2022-04-11 | Dismissed | administrative-law circuit-split drug-exclusivity fda fda-regulation lambert-eaton-myasthenic-syndrome orphan-drug-act rare-disease statutory-interpretation | Does the ODA unambiguously foreclose FDA's decades-long, consistent interpretation that the scope of orphan-drug exclusivity is tied to a drug's appro… |