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Sanofi Settles Lantus Insulin Lawsuit With Rivals

A less-expensive version of Lantus may be available next year

Insulin glargine (Lantus, Sanofi), the world’s top-selling insulin and Sanofi’s top product, could have a less-expensive competitor on the market by late 2016 following settlement of a lawsuit.

The settlement in the lawsuit over patents for insulin glargine injection (Lantus SoloStar, Sanofi), the once-daily insulin in a pen-like injector, allows rivals Eli Lilly and Co. and German drugmaker Boehringer Ingelheim GmbH to sell their version, Basaglar in their Kwikpen device, in the U.S. starting on Dec. 15, 2016.

The settlement ends all lawsuits worldwide between the companies over patents for Lantus SoloStar, the Associated Press reports. Lily will pay undisclosed royalties to Sanofi in exchange for a license to certain Sanofi patents that would have kept Basaglar off the U.S. market until April 2025. The settlement doesn't involve other Sanofi insulin products, such as Toujeo, successor to its insulin glargine (Lantus), which was launched in February and uses smaller insulin amounts.

According to Sanofi and British research firm GlobalData, 61% of the $12.4 billion 2014 insulin glargine (Lantus) sales came from the insulin glargine injection pen (Lantus SoloStar) and the rest from the vials. The pen-like devices are gaining popularity due to ease of use compared with vials.

Eli Lilly and Boehringer Ingelheim have not sought approval to sell their version in vials. They already sell Basaglar in the Kwikpen in several European countries and are seeking approval in other nations. Tentative approval for Basaglar was obtained from the FDA in August 2014 because of the ongoing lawsuit. Eli Lilly and Boehringer Ingelheim will still need full FDA approval before selling the products in the U.S. The two companies have not set a U.S. price, but it likely will be significantly lower than the price for Sanofi’s Lantus SoloStar.

The diabetes market is fiercely competitive, and top rivals recently have been introducing new products across several classes of diabetes pills, as well as easier-to-use insulins. Worldwide, the market for type-2 diabetes treatments was $23.5 billion last year and is forecast to rise to $39 billion by 2021, according to GlobalData.

Source: Associated Press; September 28, 2015.

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