The market for losartan, an active ingredient used in the treatment of hypertension and certain types of heart failure, has experienced some notable developments in recent years. Losartan is an angiotensin II receptor blocker (ARB) that works by relaxing blood vessels, thereby lowering blood pressure.
According to the Drug Patent Watch website, losartan has been available in the market under various brand names, including Cozaar and Hyzaar [1]. These brand names are associated with specific pharmaceutical companies that hold the patents for their respective formulations of losartan. However, it is important to note that losartan is also available as a generic drug, which means that multiple manufacturers can produce and sell it under different brand names.
In recent years, there have been concerns regarding the quality and safety of losartan products. In 2019, Sandoz Inc., a pharmaceutical company, issued a voluntary nationwide recall of one lot of losartan potassium and hydrochlorothiazide due to the detection of an impurity called N-nitrosodiethylamine (NDEA) [2]. NDEA is a potential human carcinogen, and its presence in losartan raised concerns about the safety of the medication.
Additionally, the European Directorate for the Quality of Medicines & HealthCare (EDQM) issued a statement regarding the risk of mutagenic azido impurities in losartan active substance [3]. This further highlighted concerns about the quality and safety of losartan products.
These developments emphasize the importance of ensuring the quality and safety of losartan products in the market. Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), play a crucial role in monitoring and addressing these concerns to protect public health.
In conclusion, the market for losartan as an active ingredient is significant, with various brand names and generic versions available. However, recent recalls and concerns about impurities have highlighted the need for stringent quality control measures to ensure the safety of losartan products.
Sources:
[1] Drug Patent Watch. "Losartan." Retrieved from: https://www.drugpatentwatch.com/p/tradename/LOSARTAN
[2] U.S. Food and Drug Administration. "Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)." Retrieved from: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-nationwide-recall-one-lot-losartan-potassium-and-hydrochlorothiazide-due
[3] European Directorate for the Quality of Medicines & HealthCare. "Risk of the presence of mutagenic azido impurities in losartan active substance." Retrieved from: https://www.edqm.eu/en/-/risk-of-the-presence-of-mutagenic-azido-impurities-in-losartan-active-substance