As a result of much prodding from several drug makers, the U.S. Food and Drug Administration stated on Friday, February 21, that, “new prescription drugs that contain both original and previously approved active ingredients will be awarded five years of marketing exclusivity, up from three,” reported an article in Law360.
"In light of the increasing importance of fixed-combination products to treat serious diseases and conditions ... FDA has concluded that the new interpretation urged by the petitioners would be beneficial to the public health," the FDA wrote in their draft proposal.

The FDA’s decision was the result of citizen petitions filed by several pharmaceutical companies, including Ferring Pharmaceuticals, Inc., represented by Buchanan Ingersoll & Rooney’s Edward Allera

Read the full article – “FDA Reverses Course On Exclusivity For New Drug Combos” (Law360, February 21, 2014)