In this month's issue, Sanjay Reddy and coauthors examine patent challenges and litigation on inhalers for asthma and chronic obstructive pulmonary disease (COPD).

Limited generic competition for inhalers raises questions about whether current policies for challenging patents are adequately facilitating the entry of complex generic drug-device combinations, explain the authors.

The authors posit that the reason for low generic competition may be that the system is “failing to motivate the timely availability of generic versions of complex drug-device combinations.”

To evaluate this, Reddy and coauthors examine abbreviated new drug applications with paragraph IV certifications for all brand-name inhalers approved during the period 1986–2020.

The authors' findings point to several policy reforms that could facilitate the entry of generic inhalers.

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