Lannett (LCI) Sings Exclusive Distribution Agreement for Generic SPIRIVA® Handihaler®

July 29, 2021 6:53 AM EDT

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Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into an exclusive U.S. commercialization agreement for a therapeutically equivalent generic of Spiriva® Handihaler® (Tiotropium Bromide inhalation powder) with Respirent Pharmaceuticals Co. Ltd. The 10-year term of the agreement commences upon distribution of the product. U.S. sales of Spiriva Handihaler were $1.5 billion for the 12 months ending May, 2021 according to IQVIA, although actual generic market values are expected to be lower.

"We continue to add drug and device combination respiratory medications to our pipeline. We believe such products provide durable sales opportunities with relatively fewer competitors, due to the technical expertise, specialized manufacturing and financial commitment required to develop these products," said Tim Crew, chief executive officer of Lannett. "With generic Spiriva Handihaler, our strategic relationship with Respirent now includes three inhaler products, each of which has the potential to be a meaningful contributor to our company's financial performance. The generic Spiriva Handihaler product is currently in development and tracking to Abbreviated New Drug Application (ANDA) submission in 2023."

As previously disclosed, Lannett and Respirent are collaborating on two other inhaler products. For generic of ADVAIR DISKUS® (Fluticasone Propionate – Salmeterol Xinafoate Powder Inhaler), Lannett announced in June 2021 that the U.S. Food and Drug Administration (FDA) had accepted the ANDA, with priority review. For generic Flovent® Diskus® (Fluticasone Propionate Powder Inhaler), the company said development is underway and an ANDA submission is expected in 2022.

Spiriva® Handihaler® is a registered trademark of Boehringer Ingelheim. ADVAIR DISKUS® and Flovent® Diskus® are registered trademarks of GlaxoSmithKline.



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