TUESDAY, Nov. 21, 2023 (HealthDay News) — Insulin manufacturers have employed strategies to extend periods of market exclusivity on brand-name insulin products, including filing patents after U.S. Food and Drug Administration approval, according to a study published online Nov. 16 in PLOS Medicine.
Anders Olsen, M.D., from Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues examined how manufacturers have used patents and regulatory exclusivities on insulin products approved from 1986 to 2019 to extend market exclusivity using the publicly available FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) to identify all approved biosynthetic insulin products. The duration of expected protection was examined as the primary outcome, determined by subtracting the FDA approval date for each product from its last-to-expire patent or regulatory exclusivity. During the study period, 56 individual products across 25 originator brand-name insulin lines and five follow-ons across 3 different insulin lines were approved by the FDA.
The researchers found that manufacturers of nine products approved during the study period obtained patents filed after FDA approval that extended their duration of expected protection. Of all patents on drug-device combinations approved during the study period, about 63 percent were related to delivery devices. On insulin products and insulin lines, the median durations of expected protection were 16.0 and 17.6 years, respectively.
“Our study highlights how manufacturers have listed an increasing number of patents on insulin products over the years,” coauthor William B. Feldman, M.D., also from Brigham and Women’s Hospital and Harvard Medical School, said in a statement. “These patents can delay competition and keep prices high for patients.”
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