AstraZeneca sues Lupin on Nexium IV generic

AstraZeneca sued India’s Sun Pharmaceuticals Industries Ltd. to prevent it from selling a generic form of the ulcer medicine Nexium IV in the U.S. before 2014. Sun is seeking U.S. Food and Drug Administration approval to sell Nexium in a form that is delivered through intravenous injections. AstraZeneca claims the generic copy would infringe two patents that expire in May 2014 and November 2014. Nexium IV, first approved by regulators in 2005, is similar to the “purple pill” that is most commonly sold as a capsule. Nexium in all forms generated $2.84 billion in U.S. sales last year for the London-based company, AstraZeneca said Jan. 28. Global Nexium sales were $4.96 billion, making it AstraZeneca’s biggest seller. Nexium IV is a small part of sales and is typically given while people are in the hospital through an intravenous drip, said Blair Hains, a spokesman for the company. He said the company doesn’t break out sales of Nexium IV. AstraZeneca settled patent claims against Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd., with both agreeing not to sell the Nexium pill until 2014. Similar suits are still pending against Lupin Ltd. and Dr. Reddy’s Laboratories Ltd., AstraZeneca said.

Teva entered into agreement with AstraZeneca regarding Prilosec® (omeprazole) and Nexium® (esomeprazole) generics

Teva Pharmaceuticals has entered into two definitive agreements with AstraZeneca to settle patent litigation regarding Teva's US generic versions of AstraZeneca's Prilosec® (omeprazole) and Nexium® (esomeprazole), including all claims for patent infringement and damages. Under the terms of the omeprazole agreement, Teva will obtain a release for all past sales of its generic omeprazole and will continue to market its product in the US and will make a one-time payment to AstraZeneca. As part of the esomeprazole agreement, AstraZeneca has granted Teva a license, subject to regulatory approval, to enter the US market with its generic esomeprazole delayed-release capsules on May 27, 2014, or earlier in certain circumstances. Additional details were not disclosed. Merck Sharp & Dohme Corp, through KBI Inc. and KBI-E, and under the terms of Merck's restructured partnership with AstraZeneca, announced in 1998, also entered into the settlement agreements.

AstraZeneca Loses Appeal against Dr. Reddy's for generic Prilosec

The U.S. Court of Appeals for the Federal Circuit has rejected AstraZeneca AB’s appeal of a lower court decision that Dr. Reddy's Laboratories Ltd.’s generic version of popular over-the-counter antacid Prilosec did not infringe (omeprazole delayed-release) capsules OTC did not infringe two US patents, Nos 5,900,424 and 5,690,960. Judge Colleen McMahon of the U.S. District Court for the Southern District of New York dismissed the suit in March, finding thatDr. Reddy’s drug used a different form of omeprazole magnesium (with less than 1 percent crystallinity), the primary ingredient in Prilosec, than that covered in the AstraZeneca patents.

Astra argued that Dr. Reddy’s had infringed its patents based on the doctrine of equivalents, but Judge McMahon deflated that line of reasoning, as well. “Because AstraZeneca argued to the USPTO that its patented product could be distinguished from other products because it was more than 70 percent crystalline, it cannot now argue that a product less than 70 percent crystalline infringes under the doctrine of equivalents,” she said.