Lannett enters into distribution agreement for generic Advair Diskus

Lannett has entered into an exclusive U.S. distribution agreement for Respirent’s generic Advair Diskus (fluticasone propionate – salmeterol xinafoate powder inhaler), which is still pending approval with the Food and Drug Administration.

Advair Diskus had a market value of $3.6 billion for the 12 months ending July, 2019, according to IQVIA, although actual generic market values are expected to be lower.

Under the agreement, Lannett will commence U.S. distribution of the product after FDA approval.  Lannett will make an upfront payment, as well as future milestone payments, and receive a portion of the net profits once it commences distribution of the product.  The term of the agreement is 10 years, which begins upon commencement of distribution.  Other terms were not disclosed.

"We are pleased to establish a strategic alliance with Respirent, a respiratory focused company developing dry powder inhaled respiratory pharmaceutical products," Lannett CEO Tim Crew said, adding,  "Moreover, Respirent has substantial capabilities around inhalation products and the distinction of being one of the few companies that have progressed generic Advair Diskus through the clinical stage.  We are working with the Respirent team to complete the product filing, which we expect to submit to the FDA in the second half of our current fiscal year.

"Generic Advair Diskus represents a potentially large market opportunity, especially for a company of our size.  Over the last 18 months, our strategy for in-licensing products has been focused on near-term opportunities; more recently, we have begun layering in products that have the potential to drive substantial growth to our business over the medium term and beyond."

GlaxoSmithKline is the brand manufacturer of Advair Diskus.