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orphan drug
In the U.S., the Orphan Drug Designation gives the manufacturer a 7 year market exclusivity once the drug goes to market.
In Europe, the designation - termed Orphan Medicinal Product - typically allows for 10-year market exclusivity upon commercialization in the 15-member states of the European Union.
Specific
carglumic acid (Carbaglu)
General
pharmaceutical agent
References
http://www.neurochem.com/ResearchActivities.htm