Of the 62 inhalers approved by the U.S. Food and Drug Administration since 1986, some have proposed new drug innovations, according to a study published online May 17 in Health Affairs.

Noting that inhalers face limited competition from common drugs in the United States, William B. Feldman, MD, Ph.D., of Brigham and Women’s Hospital in Boston, and his colleagues analyzed all patents and regulations granted to treatment providers. and chronic obstructive pulmonary disease. approved by the FDA between 1986 and 2020.

A total of 53 of the 62 approved inhalers were branded products and they had an average 16-year period of protection against competition from common drugs. The researchers found that only one inhaler contained an ingredient with a new mechanism of action. Of the patents more than half were on the inhaler rather than on the active ingredients or other aspects drug-combinations of devices. Moving active ingredients from one inhaler device in another, manufacturers have increased periods of exclusivity in the brand market (“devices”). It took 28 years from the approval of the original product to the latest patent or regulatory exclusivity of the brand’s next items.

“Drug manufacturers have used a variety of strategies over the past thirty-five years to obtain exclusive rights and patents for branded inhalers to restrict generic competition,” the authors write. “Regulatory and patent reforms are crucial to ensure that the awards given to brand manufacturers better reflect the additional clinical benefits of new products.”

One author disclosed financial ties to the health insurance industry; the second author revealed links with Arnold Ventures and acted as an expert against Gilead.


The first generic symbicort has received FDA approval


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Citation: Regulatory Legal Reform, Patent Reform Required for Inhalers for Asthma Treatment, COPD (2022, May 21) Retrieved May 21, 2022, from https://medicalxpress.com/news/2022-05-regulatory-patent-reform -inhalers-asthma.html

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