British drug maker AstraZeneca’s blockbuster stomach acid drug –“Nexium” is threatened by the launch of a Nexium (NDA esomeprazole strontium product) by South Korea’s Hanmi Pharmaceutical and its US marketing partner Amneal Pharmaceuticals.

The drug formulations of two companies are so strikingly similar (differs in just their salt forms) that it led to a patent battle between AstraZeneca and Hanmi. Amidst the ongoing lawsuit, after a U.S. federal court lifted a stay on Hanmi’s launch permitting the company to launch its version. AstraZeneca appealed against this decision and is still awaiting the result which is expected to come in early 2014. If Hanmi loses, it might have to shell out huge sum of money in patent infringement damages. However, what both the companies fail to realize is that when Nexium patent expires in 2014, regardless of the outcome of the patent infringement suit, the involved companies will have to compromise on Nexium’s revenues.

Nevertheless, there is a fuss around Nexium and it can be attributed to the fact that it is one of the top 5 branded drugs whose global sales figures have touched the groundbreaking number of $3.94 billion in 2012. Thus, it contributes 14% of total branded drug sales of AstraZeneca. Of this, $2.27 billion comes from the U.S., and Hanmi’s product could compromise these revenues.

Note that AstraZeneca had suffered bitter sales losses in last year with its Seroquel patent expiration also. AstraZeneca’s type-2-diabetes treatment, called dapagliflozin that it developed in collaboration with with U.S. firm Bristol-Myers Squibb Co. is also awaiting US FDA approval for which decision will be taken in Jan, 2014. Dapagliflozin is already marketed in the EU and 37 other countries under the trade name Forxiga, having gained EU approval in November 2012. So, if copycats descend on Nexium, AstraZeneca is in big trouble as even the patent rights for OTC version of the treatment are also with Pfizer who bought it for a whopping $250 million.

About Nexium (esomeprazole)

Nexium belongs to a group of drugs called proton pump inhibitors. The drug decreases the amount of acid produced in the stomach.

• It is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome.

• To promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).

• To prevent gastric ulcer caused by infection with helicobacter pylori (H. pylori), or by the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

We have extensively discussed the problem of patent cliff and some of the positive points of the problem of patent cliff in our previous blog article titled “Scaling Ahead of The Problem of Patent Cliff”. Patent cliff is nothing but phenomena of patent expiration and consequent drop in sales that follows for a group of products capturing high percentage of a market.

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