AstraZeneca And Ranbaxy Settle Nexium Dispute

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handshake-flickrThis looks like a win-win, at least for the drugmakers. For AstraZeneca, the deal means a generic version of its best-selling ulcer med, which racked up $5.2 billion in sales last year, won’t appear in pharmacies this week. That’s when a 30-month stay barring a generic would have expired. “The agreement allows us to spend more of our time and money in the laboratory and less in the courtroom,” says AstraZeneca ceo Dave Brennan, according to Bloomberg News.

For Ranbaxy Laboratories, the deal offers different enticements - the Indian generic maker will become the US distributor for authorized generic versions of two other meds, Plendil and a 40 mg version of Prilosec, for which it will be compensated. Ranbaxy, which acknowledged all six AZ Nexium patents are valid and enforceable, will be allowed to sell a generic Nexium starting in 2014. And Ranbaxy will also manufacture the active pharmaceutical ingredient in Nexium, beginning next year, a move that underscores AZ’s desire to outsource its API manufacturing, although the drugmaker last fall tried to deny its plans.

“This move is absolutely consistent with our supply chain strategy,” Brennan told reporters. “We have been looking to outsource our manufacturing where we can… we have long term plans to exit all API production over the next five to 10 years.”

In its statement, AstraZeneca maintains the deal is “in compliance with the Medicare Modernization Act of 2003,” and the drugmaker will file all of the agreements with the US Federal Trade Commission and Department of Justice. This refers to the ongoing scrutiny given what have come to be called “pay-for-delay” settlements, in which a brand-name offers a generic maker some deal to delay introduction of a copycat while the brand-name med continues to generate big sales.

The FTC recently filed a lawsuit against Cephalon accusing the drugmaker of paying more than $200 million to four rivals for keeping generic versions of its Provigial sleep-disorder pill off the market. Such deals were called “unconscionable” by Jon Leibowitz, one of five FTC commissioners, and a contributor to rising health care costs. Brennan, not surprisingly, argues that the deal is “perfectly lawful.” Whether the FTC agrees remains to be seen.

pic thx to o5com on flickr

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