More Benicar Generics Poised for US Market, Benicar Lawsuits Keep Coming

Trenton, NJAs each year draws to a close it’s useful to look back at the year just past and take stock of the previous 12 months. With Benicar side effects and, specifically sprue-like enteropathy, 2017 should see continuing litigation activity with Benicar lawsuits filed as late as December 30. With the arrival on the market of at least two sets of generics from competing manufacturers, it will be interesting to scan the horizon for even more litigious activity given the availability of olmesartan to more Americans.

Benicar (olmesartan) is an oft-prescribed drug for the treatment of hypertension (high blood pressure), a condition that impacts a sizable sector of the American population. Causes of high blood pressure can include poor diet and lack of exercise, but genetic predisposition and aging can also be a factor. Benicar (olmesartan) has been shown to effectively treat hypertension by lowering blood pressure. However, Benicar side effects continue to be a concern.

The most grievous is Benicar illness and weight loss in association with sprue-like enteropathy, a nasty gastro-intestinal condition characterized by nausea, chronic diarrhea and severe weight loss. The painful condition has landed many a patient in hospital, and subsequent Benicar lawsuits allege Benicar defective products.

Over the last several years, mounting reports of sprue-like enteropathy prompted the US Food and Drug Administration (FDA) to issue a warning about the link between olmesartan and sprue-like enteropathy, suggesting in no uncertain terms the regulator’s finding of “clear evidence of an association between olmesartan and sprue-like enteropathy,” in its warning issued in 2013. An update to the Benicar label was undertaken at the behest of the FDA, with the regulator indicating it would be keeping a close eye on the file.

Now, olmesartan is available to even more Americans thanks to the expiry of the olmesartan patent which gave Daiichi Sankyo exclusive manufacturing and distribution rights. At least two competing pharmaceutical companies have announced generic versions of olmesartan: Mylan Pharmaceuticals Inc., which rolled out generic versions of Benicar and Benicar HCT (Olmesartan Medoxomil and Hydrochlorothiazide) earlier this year, and Lupin Limited (Lupin), a more recent player in the US pharmaceutical market.

Based in Mumbai, India Lupin Limited set up shop in Baltimore, Maryland as Lupin Pharmaceuticals Inc. The manufacturer announced last month that it has secured tentative FDA approval for a generic version of Benicar.

Generics are inherently less expensive than branded, heritage drugs with the expectation that olmesartan will be available to more people. Increased use is presumed to translate into additional complaints of Benicar side effects, including sprue-like enteropathy.

Meanwhile, the Benicar lawsuits keep coming. Three of the most recent were filed December 30 2016 in New Jersey: Ward v. Daiichi Sankyo, Inc. et al, Case No. 1:16-cv-09591, Hank et al v. Daiichi Sankyo, Inc. et al, Case No. 1:16-cv-09590 and Williams v. Daiichi Sankyo, Inc. et al, Case No. 1:16-cv-09610. Benicar lawsuits are consolidated in multidistrict litigation before US District Judge Robert B. Kugler in MDL 2606.