On January 26, 2017, AstraZeneca announced that the FDA granted six months of pediatric exclusivity for Symbicort (budesonide/formoterol) inhalation aerosol, a fixed-dose inhaled corticosteroid and long-acting beta2-agonist bronchodilator (ICS/LABA), for the treatment of asthma in children ages six to 12 years.
Symbicort, also approved for the treatment of asthma in patients 12 years and older and as a maintenance therapy for adult chronic obstructive pulmonary disease (COPD) patients, will have an additional six months of patent protection in the US for each of its licensed indications. Pediatric exclusivity marks a substantial win for AstraZeneca, as Symbicort, with 2015 sales totaling $1.52 billion in the US alone, now has the potential to generate hundreds of millions of dollars in additional revenue.
The FDA’s decision to grant pediatric exclusivity was based on the evaluation of clinical trials conducted by AstraZeneca assessing the use of Symbicort in children ages six to 12 with asthma in response to a Written Request from the FDA, a prerequisite to qualify for pediatric exclusivity. The FDA extends a Written Request for a pediatric study to a company with a drug that has the potential to provide significant health benefits to the pediatric patient base. Fortunately for AstraZeneca, pediatric exclusivity will delay opening Symbicort up to generic brand competition by six months, holding off what could be a significant decline in US sales.
Outside the US market, Symbicort has been under pressure for the last few years following the patent expiry of GlaxoSmithKline’s ICS/LABA Seretide (fluticasone/salmeterol) Diskus in 2013 in the EU, opening up the ICS/LABA drug class to generic competition. Although Symbicort’s patent does not expire until 2018 at the earliest in the EU, drug sales dropped by 14% in 2015 due to pricing competition from the generic market, including from Teva’s Aerivio Spiromax(fluticasone/salmeterol) and Sandoz’s AirFluSal Forspiro (fluticasone/salmeterol). Therefore, GlobalData anticipates a six-month extension to Symbicort’s patent expiration date will give AstraZeneca a much needed advantage in the ICS/LABA market space for the treatment of asthma and COPD.