Patent Expirations and Market Impact
Aclidinium bromide/formoterol (Duaklir Pressair)
Mechanism of Action: Beta 2 adrenergic receptor agonists; Cholinergic receptor antagonists; Muscarinic M3 receptor antagonists Drug class: Small molecules Originator: Laboratorios Almirall Developer: Allergan; Almirall S.A.; AstraZeneca; Forest Laboratories; Kyorin Pharmaceutical; NIOX Indications: Chronic obstructive pulmonary disease (COPD) Patent expiry: February 2025
Duaklir Pressair market revenue for eight years (2015-2022)
Duaklir Pressair experienced steady revenue growth in recent years, with a decline in 2019. Most of the sales were in Europe, where revenue fell by 22% (17% at CER) to $71 million, primarily due to weaker performance in Germany. Under a collaboration agreement announced in March 2017, Circassia Pharmaceuticals took over the commercialization of Duaklir in the U.S., while AstraZeneca continued to manufacture and supply the product. Revenue also dipped in 2022 after AstraZeneca sold the global rights to Eklira (Tudorza in the U.S.) and Duaklir to Covis Pharma for an upfront payment of $270 million, which was recorded under Other Operating Income and Expense. The intangible assets of $368 million were classified as Assets held for sale as of December 31, 2021.
How will the patent expiry of Duaklir Pressair affect the market?
Duaklir Pressair was a key revenue-generating drug for Covis Pharma. With its patent expiration approaching, the company is expected to face a substantial decline in sales as generic alternatives enter the market. This will likely intensify price competition and erode the market share of the branded product, potentially impacting the company's overall financial performance.
“With the patent expiry of Duaklir Pressair (a LABA-LAMA combo for COPD), generic versions can enter the market, offering cheaper alternatives. This will increase competition and could reduce sales for AstraZeneca’s branded products as patients and providers opt for more affordable generics.”