Lannett has submitted an ANDA to the Food and Drug Administration for its strategic partner, Respirant's fluticasone propionate and salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg).
The product is the generic of GlaxoSmithKline’s Advair Diskus.
The product has a market value of approximately $3 billion for the 12 months endedFebruary 2021, although actual generic market values are expected to be lower, according to IQVIA.
"The ANDA submission of generic Advair Diskus marks a significant advancement toward our goal of adding larger and more durable products to our portfolio," said Lannett CEO Tim Crew. "We anticipate a rigorous FDA review, extending beyond one review cycle, for the ANDA, given this is a complex combination drug/device product, involves two active pharmaceutical ingredients, APIs and includes multiple dosage strengths.
"Currently, our agreements with Respirent include generic Advair Diskus, as well as a second powder inhaler product, generic Flovent Diskus (Fluticasone Propionate Powder Inhaler). A key element of our growth strategy is to further build a franchise of respiratory drug/device products, and we are currently evaluating and in negotiation for additional product opportunities. We believe we have gained valuable experience during the development of the product and will learn important insights on the regulatory front, which we can bring to bear on these potential future opportunities."
Crew continued, "We continue to build an effective, close working relationship with our colleagues at Respirent – a team that has expertise and a deep working knowledge in developing, filing and manufacturing inhalation products and is committed to bringing affordable respiratory products to market."
As previously announced, Lannett entered into an exclusive U.S. distribution agreement for the therapeutically equivalent generic of Respirent's Advair Diskus. Under the agreement, Lannett will commence U.S. distribution of the product after FDA approval and receive a portion of the net profits once it commences distribution of the product. The companies recently extended the term of the agreement to 12 years, which begins upon commencement of distribution. Other terms were not disclosed.