Economics In 2010, valsartan (trade name Diovan) achieved annual sales of $2.052billion in the United States and $6.053billion worldwide. The patents for valsartan and valsartan/hydrochlorothiazide expired in September 2012.
Combinations ) Versions are available as the combinations
valsartan/hydrochlorothiazide,
valsartan/amlodipine,
valsartan/amlodipine/hydrochlorothiazide,
valsartan/nebivolol, and
valsartan/sacubitril. Valsartan is combined with
amlodipine or
hydrochlorothiazide (HCTZ) (or both) into single-pill formulations for treating hypertension with multiple drugs. Valsartan is also available as the combination
valsartan/sacubitril. It is used to treat
heart failure with reduced ejection fraction.
Recalls In July 2018, the
European Medicines Agency (EMA) recalled certain batches of valsartan and valsartan/hydrochlorothiazide film-coated tablets distributed in 22 countries in the European Union. (ZHP) in
Linhai, China manufactured the bulk ingredient contaminated by
N-nitrosodimethylamine (NDMA), a
carcinogen. The
active pharmaceutical ingredient was subsequently imported by a number of generic drugmakers, including
Novartis, and marketed in Europe and Asia under their subsidiary
Sandoz labeling, and in the UK by Dexcel Pharma Ltd and Accord Healthcare. Authorities believe the degree of contamination is negligible. In July 2018, The
National Agency of Drug and Food Control (NA-DFC or Badan POM Indonesia) announced voluntary recalls for two products containing valsartan produced by Actavis Indonesia and Dipa Pharmalab Intersains. In July 2018, the US
Food and Drug Administration (FDA) announced voluntary recalls of certain supplies of valsartan and
valsartan/hydrochlorothiazide in the US distributed by Solco Healthcare LLC, Major Pharmaceuticals, and
Teva Pharmaceutical Industries. In August 2018, the FDA published two lengthy, updated lists, classifying hundreds of specific US products containing valsartan into those included versus excluded from the recall. A week later, the FDA cited two more drugmakers, Zhejiang Tianyu Pharmaceuticals of China and
Hetero Labs Limited of India, as additional sources of the contaminated valsartan
ingredient. According to a 2018
Reuters analysis of national medicines agencies' records, more than 50 companies around the world have recalled valsartan mono-preparations or combination products manufactured from the tainted valsartan ingredient. The contamination has likely been present since 2012 when the manufacturing process was changed and approved by
EDQM and FDA authorities. Based on inspections in late 2018, both agencies have suspended the Chinese and Indian manufacturers' certificates of suitability for the supply of valsartan in the EU and the US. In 2019, many more preparations of valsartan and its combinations were recalled due to the presence of the contaminant NDMA. In August 2020, the
European Medicines Agency (EMA) provided guidance to marketing authorization holders on how to avoid the presence of nitrosamine impurities in human medicines and asked them to review all chemical and biological human medicines for the possible presence of nitrosamines and to test the products at risk. The FDA issued revised guidelines about nitrosamine impurities in September 2024.
Shortages Since July 2018, numerous recalls of
losartan, valsartan and
irbesartan drug products have caused marked shortages of these life saving medications in North America and Europe, particularly for valsartan. In March 2019, the FDA approved an additional generic version of valsartan to address the issue. According to the agency, the shortage of valsartan was resolved in April 2020, but the availability of the generic form remained unstable into July 2020. Pharmacies in the European Union were notified that the supply of the drug, particularly for higher dosage forms, would remain unstable well into December 2020. ==Research==