- Until recently, fixed-dose combinations that included at least one new chemical entity (NCE) enjoyed three years of marketing exclusivity, while combos with two new NCEs enjoyed five years of marketing exclusivity.
- Pharma companies requested that all fixed-dose combination products be eligible for five years of exclusivity, arguing that many of the newest treatments that are both safer and more effective are fixed-dose combo drugs that contain an old NCE.
- The FDA has decided that it will alter its policy so that all fixed-dose combo drugs are eligible for five years of market exclusivity; however, this only applies to drugs approved on or after October 10, raising considerable ire among pharmaceutical companies.
In spite of several citizens' petitions, the FDA is standing by its guidance. But two years makes a big difference when it comes to market exclusivity. Pharma companies know this and are eager to find a way to gain five-year eligibility for fixed-dose combos approved before October 10.
One giant that would like to have its fixed-dose combo eligible for five-year exclusivity is Gilead, which would like the FDA to grant Stribild five years of exclusivity. Stribild, which is a combination of elvitegravir, cobicstat, emtricitabane, and tenofovir, is comprised of two old drugs and two new drugs. Stribild was previously granted three years of exclusivity, and two more years would mean billions more in sales.
Cases like the Stribild case and many others are sure to prompt a flurry of requests for special consideration by the FDA. Overall, the new guidance bodes well for pharma companies launching new fixed-dose combos.