After months of anticipation, the FDA last night finally gave a Ranbaxy Laboratories its formal blessing to sell a generic version of Lipitor. The best-selling cholesterol pill, as you know, lost patent expiration yesterday and the event symbolized the end of an era for the pharmaceutical industry, which rose to riches in past years on the backs of such one-size-fits-all blockbuster meds.

Although details remain sketchy, Ranbaxy has a deal with Teva Pharmaceuticals, which already sells a generic Lipitor in Canada, to help supply the pill. The arrangement was first reported early last month (read this), and a portion of the profits from the 180-day exclusivity period will be paid to Teva, according to a Ranbaxy statement.

The last-minute FDA approval (read here) occurred just as the 180-day exclusivity period was about to begin, although there was an on-again, off-again feel to the announcement. Last night, the FDA issued a press release signaling approval, but retracted its statement moments later, only to formally post the approval on its web site shortly afterwards.

The FDA move came after a period of intrigue, because Ranbaxy ran afoul of agency regulations. Three years ago, federal prosecutors cited Ranbaxy for allegedly falsifying records resulting in the production and sale of meds that failed to meet FDA standards. The charges included fabricating bioequivalence and stability data. Later, the FDA issued warnings letters and banned more than 30 meds made at two plants (see this).

As a result, there had been rampant speculation that Ranbaxy may not win FDA approval to sell a generic Lipitor by the time the Pfizer patent expired. In 2002, Ranbaxy was the first to file an application with the FDA for clearance to sell generic Lipitor. Meanwhile, Mylan Laboratories filed an unsuccessful lawsuit in hopes of forcing the FDA to act on the Ranbaxy application (look here), although there is speculation that Mylan may return to court. An authorized generic from Watson Pharmaceuticals went on sale yesterday.

However, the FDA approval did not mention any of the manufacturing issues. Ranbaxy will rely on its Ohm Laboratories facility in Princeton, New Jersey, but not its two plants in India that caused the manufacturing problems. An FDA spokeswoman wrote us last night to say that, “for this approval, the facilities being used in the production of this product were inspected and found acceptable. On more broad Ranbaxy issues and issues involving other plants, we cannot comment.”

[UPDATE: Wall Street, meanwhile, speculates Teva may jump in. "It is uncertain whether Ohm has enough supply for the US market. If it does not, Ranbaxy and Teva may choose to launch Teva's product as well," write Bernstein Research analyst Ronny Gal. "This can be done as a selective waiver (after it sells the first pill, Ranbaxy can selectively waive exclusivity). The question is whether the Teva product is approvable. There are no tentative approvals on the FDA site, yet."]

There was also no word about any settlement for the manufacturing violations, a related topic that similarly generated significant settlement, given that some reports suggested Ranbaxy may eventually pay hundreds of millions of dollars in fines. Ranbaxy, meanwhile, may reap an equivalent amount in generic Lipitor sales over the next months, according to analyst estimates. Neither the FDA nor Ranbaxy have commented on this particular topic.

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