Lannett has entered into an exclusive U.S. distribution agreement for Respirent Pharmaceuticals’ generic of GSK’s Flovent Diskus (fluticasone propionate powder inhaler).
According to the Orange Book, all patents covering Flovent Diskus have expired, the company said.
Flovent Diskus had a market value of $94 million for the 12 months ended June 2020, according to IQVIA, although actual generic market values are expected to be lower.
The company also said its previously announced exclusive U.S. distribution agreement with Respirent for the generic of GSK’s Advair Diskus (fluticasone propionate – salmeterol xinafoate powder inhaler) has been extended from 10 years to 12 years. The term of the agreement commences upon distribution of the product. The company further noted that the earlier trademark lawsuit between Respirent and the innovator company was recently dismissed, thereby clearing a potential impediment to commercialization.
"Expanding our relationship with Respirent for a second powder inhaler product for asthma speaks to the mutual respect we have for each other's expertise. Generic Flovent Diskus is a large market opportunity product that complements our increasingly important portfolio of inhalation medications," said Tim Crew, Lannett CEO. "Extending the distribution period for generic Advair Diskus reflects our growing optimism for the product. We remain on track to submit late this calendar year an ANDA for this product."
Crew added that early development is underway for the generic Flovent Diskus product and the company will provide updates as clinical milestones are achieved.