FDA Backs Teva Pharmaceutical Industries Limited's Generic Nexium in Blow to AstraZeneca PLC, Ranbaxy Laboratories

FDA Backs Teva Pharmaceutical Industries Limited's Generic Nexium in Blow to AstraZeneca PLC, Ranbaxy Laboratories
January 27, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff

Jerusalem-based biopharmaceutical company Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has approved of the first generic version of Nexium Delayed Release Capsules, also known as someprazole magnesium, for sale in the U.S.

At the moment, AstraZeneca PLC markets Nexium Delayed Release Capsules, and Ranbaxy Laboratories has a license to a generic version of the drug.

AstraZeneca makes approximately $6 billion in sales from Nexium Delayed Release Capsules in the U.S. Nexium is designed to treat heartburn, gastroesophageal reflux disease and stomach ulcers. Some patients also take the drug to prevent stomach issues that arise from pain medication. The FDA’s approval of the generic version of Nexium could impact AstraZeneca’s overall bottom line.

The Delay of Generics
In December 2014, Reuters reported that AstraZeneca reached an agreement with Ranbaxy Laboratories to delay the launch of a generic version of Nexium, and a Massachusetts jury did not find the decision to be anticompetitive. The move was considered a “pay-for-delay” settlement, which cost consumers $3.5 billion each year.

Ranbaxy had previously planned to launch a generic version of the drug in 2014, but the FDA revoked its approval after finding issues with the manufacturing process.

The Launch of Nexium Direct
In March 2014, AstraZeneca announced that it would be launching a program called Nexium Direct, which allows eligible patients to have the drug delivered directly to their door. The program is a part of AstraZeneca Direct, a Web-based service that allows AstraZeneca-produced medications to be delivered to homes.

“Today, people are taking a more active, participatory role in their healthcare,” said Linda Palczuk, vice president of Cornerstone and Commercial Excellence at AstraZeneca, at the time of the announcement. “With this in mind, AstraZeneca has created Nexium Direct, giving patients and prescribers a Nexium when it comes to how they receive branded Nexium from AstraZeneca. Nexium has been a treatment option for acid reflux disease for over 13 years, with more than 236 million prescriptions written. We’re proud to offer patients and prescribers another way to receive this important treatment.”

Nexium Direct does not require patients to utilize coupons or co-pays. Those who enroll in the program also have access to a 24-hour support center.

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