Exclusivity Start Date

Generic Name

Trade Name

Indication for Original Approval


Ibuprofen lysine


For closure of a clinically significant patent ductus arteriosus in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support) is ineffective


Balsalazide disodium


Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older




Treatment of juvenile rheumatoid arthritis

NOTE: This list includes drugs that received approval only for a pediatric orphan indication. Remicade, which received a pediatric orphan approval for the treatment of pediatric Crohn’s disease, is also approved for an adult orphan indication and was therefore included in a previous list of drugs. The drugs are sorted by the exclusivity date (i.e., date of approval of orphan indication) for first orphan approval with a relevant indication. Drugs with multiple orphan designations often have different exclusivity dates associated with each approved indication. The text for some indications has been abbreviated.

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