Lexchin Joel
School of Health Policy and Management, York University, Toronto, Ontario, Canada.
Value Health. 2017 Sep;20(8):1139-1142. doi: 10.1016/j.jval.2017.05.004. Epub 2017 Jun 20.
This study looks at market exclusivity time for the top selling originator drugs in Canada. Total sales for drugs without competition were also calculated.
A list of the top selling originator drugs by dollar sales from 2009 to 2015 inclusive, except for 2010, was compiled along with their annual sales. Health Canada databases were used to extract the following information: generic name, date of Notice of Compliance (NOC, date of marketing authorization), whether the product was a small molecule drug or a biologic, and date of NOC for a generic or biosimilar. Market exclusivity time was calculated in days for drugs.
A total of 121 drugs were identified. There were 96 small molecule drugs (63 with a generic competitor and 33 with no generic competitor) and 25 biologics (none with a biosimilar competitor). The 63 drugs with a competitor had a mean market exclusivity time of 4478 days (12.3 years) (95% CI 4159-4798). The 58 drugs without competition had total annual sales of Can$8.59 billion and were on the market for a median of 5357 days (14.7 years) (interquartile range 3291-6679) as of January 31, 2017.
Top selling originator drugs in Canada have a considerably longer period of market exclusivity than the 8 to 10 years that the research-based pharmaceutical industry claims.
本研究着眼于加拿大畅销的原创药物的市场独占期。还计算了无竞争药物的总销售额。
编制了一份2009年至2015年（含2009年和2015年，但不包括2010年）按销售额排名的畅销原创药物清单及其年销售额。利用加拿大卫生部数据库提取以下信息：通用名、合规通知日期（NOC，上市许可日期）、产品是小分子药物还是生物制剂，以及仿制药或生物类似药的NOC日期。计算药物的市场独占期天数。
共识别出121种药物。其中有96种小分子药物（63种有仿制药竞争对手，33种无仿制药竞争对手）和25种生物制剂（均无生物类似药竞争对手）。有竞争对手的63种药物的平均市场独占期为4478天（12.3年）（95%置信区间4159 - 4798）。截至2017年1月31日，58种无竞争的药物年总销售额为85.9亿加元，上市中位时间为5357天（14.7年）（四分位距3291 - 6679）。
加拿大畅销的原创药物的市场独占期比研发制药行业声称的8至10年长得多。
