FDA to Grant Five-Year Exclusivity for More Fixed-Combo Drugs

October 17, 2014

The FDA has expanded market exclusivity from three to five years on all fixed-dose combination drugs that contain a new active ingredient, bowing to industry pressure for new incentives to develop the costly products. The agency, however, did not apply the policy retroactively.

The FDA previously allowed only three years of exclusivity for fixed-dose combination drugs, unless they were made up of entirely new ingredients. In final guidance released Oct. 10, the agency said it broadened the eligibility for new chemical entity (NCE) exclusivity to the products because the shorter exclusivity period was delaying the development of new combination therapies.

Drugmakers, for example, would submit single-entity NDAs to obtain the five-year exclusivity for their product before using it to develop a fixed-dose combination drug.

The final guidance, which varied little from the February draft, accomplished the change by reinterpreting the agency definition of a drug for NCE exclusivity purposes to apply to individual components rather than the product as a whole.

Drugmakers have been clamoring for the incentive to develop new fixed-dose combination drugs, which have become a key therapy in combating HIV/AIDS as well as conditions such as cancer and heart disease.

In recent citizen petitions, drugmakers such as Bayer and Gilead have argued that three years of exclusivity is not enough, a point that many lawmakers also have supported.

The guidance also noted that the FDA has approved 19 NDAs for fixed-dose combination therapies with at least one new active ingredient since it finalized its regulations on exclusivity almost 20 years ago. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.