Teva Launches Asthma Drug and Its Authorized Generic Against GSK’s Top-Selling Asthma Drug

Teva Pharmaceutical Industries has simultaneously launched AirDuo RespiClick (fluticasone propionate and salmeterol) inhalation powder and its authorized generic, fluticasone propionate and salmeterol inhalation powder (multidose dry powder inhaler), for treating asthma. AirDuo and its authorized generic are fixed-dose combination asthma therapies containing an inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA), the same active ingredients in GlaxoSmithKline’s (GSK) Advair Diskus (fluticasone propionate and salmeterol), but administered in Teva’s proprietary RespiClick inhaler. Advair is GSK’s top-selling product with 2016 sales of £3.5 billion ($4.5 billion).

The US Food and Drug Administration approved Teva’s AirDuo in January 2017 on the 505(b)(2) pathway, making it not directly interchangeable with Advair. However, Teva’s strategy of launching, at the same time, an authorized generic version of its branded AirDuo RespiClick allows it to offer a lower-price alternative while still having a branded product differentiated enough from Advair that it can use an above-generic price.

Another would-be competitor to GSK’s Advair is Mylan, which had filed an abbreviated new drug application (ANDA) for fluticasone propionate and salmeterol inhalation powder, its generic version to Advair Diskus, to the US Food and Drug Administration in Dec. 2015. However, Mylan’s ANDA filing stumbled over a Complete Response Letter (CRL) sent by the FDA in March 2017. Mylan is in the process of reviewing the CRL and expects to provide an update as soon as practicable, the company said.

GSK, which lost patent exclusivity on Advair when the US patent expired in 2010, had been immune to competition so far because of an additional patent on its Diskus inhaler, used to administer the drug. However, the patent for GSK’s Diskus inhaler is set to expire in 2017, according to GSK in its annual report. 

Source: Teva Pharmaceutical Industries

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