Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Nat Biotechnol. 2022 Sep;40(9):1319-1325. doi: 10.1038/s41587-022-01451-7.
Nebulizer therapy is a cornerstone treatment for asthma and chronic obstructive pulmonary disease (COPD). We collected and analyzed all patents and regulatory exclusivities on brand-name nebulizer solutions approved for asthma and COPD from 1986–2020, quantified periods of protection from generic competition, and compared the patenting strategies employed by manufacturers of nebulizer versus inhaler therapy. The median duration of expected protection from generic competition for brand-name nebulizer solutions (n=13) was 7 years (after subtracting time lost to early generic entry), compared to 14 years for inhalers (n=53). Through the end of 2020, brand-name nebulizers faced generic competition for 62% of all follow-up time compared to 0.5% for inhalers. Unlike inhaler manufacturers, which relied heavily on device patents to build extensive patent thickets, manufacturers of nebulizer solutions listed fewer patents overall and relied more on non-device patents. Regulatory reform is critical to help ensure that patients have access to affordable inhaled medications.
雾化器治疗是哮喘和慢性阻塞性肺疾病（COPD）的基石治疗方法。我们收集并分析了 1986 年至 2020 年间批准用于哮喘和 COPD 的品牌雾化器溶液的所有专利和监管专有权，量化了免受仿制药竞争的保护期，并比较了雾化器和吸入器治疗制造商采用的专利策略。13 种品牌雾化器溶液（n=13）预计免受仿制药竞争的保护期中位数为 7 年（扣除早期仿制药进入损失的时间），而吸入器为 14 年（n=53）。截至 2020 年底，品牌雾化器在所有随访时间中面临 62%的仿制药竞争，而吸入器为 0.5%。与严重依赖设备专利构建广泛专利丛林的吸入器制造商不同，雾化器溶液制造商的专利总数较少，更多地依赖非设备专利。监管改革对于确保患者能够获得负担得起的吸入药物至关重要。
