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The Fight to Launch Generics in Multiple Sclerosis: A Look at Recent Inter Partes Review Activity in This High-Cost, Blockbuster Market

Five disease-modifying therapies for the treatment of multiple sclerosis achieved block­buster sales in the United States in 2016. As such, it is not surprising that generic manufacturers have targeted several small molecule brands through Paragraph IV challenges, and over the last several years, through inter-partes review (IPR) as a parallel platform to attack key patents. Several key rulings have been released already in 2017, with more coming. What impact did recent inter partes reviews have on the market exclusivity of blockbusters Copaxone and Tecfidera? How will the IPR rulings, along with ongoing district court litigation, change MS market in near future? This white paper summarizes DRG’s view on how the final rulings will affect the dynamics of the broader MS market.