Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Extended Market Exclusivity


The prospect of splitting a small market with competitors may render a project financially infeasible. Provisions for market exclusivity via the existing Orphan Drug Act and the 1984 Drug Price and Competition and Patent Term Restoration Act, and/or similar means are necessary but not sufficient for lowering the barrier of a small and uncertain market. These provisions alone cannot expand the absolute size of the small market, but they can protect against competition in it and reduce uncertainty about market penetration. LAAM and naltrexone (as Trexan) have been granted orphan drug status for specified opiate indications. Broadly interpreting the Orphan Drug Act for substance abuse medications (e.g., the standard for designating orphan status to drugs intended to treat a condition affecting fewer than 200,000 people in the U.S.) or other policies giving similar market protections to drugs for this market could encourage companies to enter this market.