Teva’s Nexium copycat approved in US
pharmafile | January 27, 2015 | News story | Manufacturing and Production, Sales and Marketing | AstraZeneca, Teva, esomeprazole, gerd, heart, nsaids
Teva has won approval for its copycat form of AstraZeneca’s big-selling heatburn drug Nexium, making it the first generic version of the treatment sanctioned in the US.
The non-specific version of the capsules have been approved to treat adults and children with gastroesophageal reflux disease (GERD).
The green light for Teva comes less than a year after AZ only narrowly avoided paying fines of up to $10 billion, after being accused of violating US antitrust laws relating to its 2008 ‘pay-for-delay’ agreement to postpone the launch of a universal version of the heartburn drug.
AZ was accused of overcharging for its Nexium (esomeprazole) capsules but a Boston Court found the assertions made by numerous purchaser groups as ‘unreasonably anticompetitive’.
Teva, a subsidiary of Miami-based Ivax Pharmaceuticals will now be entitled to market its generic version of the GERD drug in 20 and 40 milligram capsules.
“Healthcare professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” comments Kathleen Uhl, who is the director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “It is important for patients to have access to treatment options for chronic conditions.”
Generic prescription treatments approved by the FDA have to meet the same high quality and strength as brand-name medicines. Non-specific drug manufacturing must pass the same quality standards as those of trademarked treatments.
According to AZ, in the first half of 2014 global sales of Nexium were estimated at almost $1.9 billion. The drug is one of the company’s biggest selling treatments and was the world’s fifth-best-selling medicine in 2013.
Furthermore, AZ received $250 million from US pharma firm Pfizer in 2012 to be able to sell its over-the-counter (OTC) version of the heartburn drug. AZ receives milestone and royalty payments for the US company’s capsules which went on sale last year.
Nexium is approved to reduce the risk of gastric ulcers associated with use of nonsteroidal anti-inflammatory drugs (NSAIDs). It can also treat conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome – a gastrointestinal disease that causes tumours to develop in the pancreas and duodenum.
GER happens when stomach contents come back up into the esophagus. Stomach acid that touches the lining of the esophagus can cause acid indigestion, or heartburn. GERD is a more serious, long-lasting chronic form of GER.
Tom Robinson
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