Indias largest drug-maker, Ranbaxy, has locked horns with the US-based worlds largest drug-maker Pfizer in 17 countries

over infringement of patent of the latters blockbuster cholesterol-lowering drug Lipitor. The companys launch of the atorvastatin (the generic drug of Lipitor) is crucial in its plan to generate nearly US$2 billion in sales over the next five-six years. The countries where Ranbaxy is into litigations with Pfizer for atorvastatin include the US, the UK, Norway, Austria, Denmark, Finland, Australia. Lipitor is the worlds largest selling drug with sales worth about US$13 billionin 2006. The patent for Lipitor expires in 2010. During 20042005, Ranbaxy had to reportedly shell out around Rs 160 crore (US$3.69 million) to fight against Pfizers Lipitor drug. Ranbaxy has about 20 first-to-file (FTF) applications pending in the US, of which about ten are in litigations with atorvastatin being the big bet. FTF gives 180-day exclusive marketing period along with the patent holder ( Asia Pacific Biotech News World Scientific Publishing Company Mar30,2007)
Dec. 17--Pfizer Inc. won a major court victory Friday when a Federal judge in Delaware ruled in its favor in a patent fight over its blockbuster Lipitor drug, an $11 billion best-seller used by more than 18 million Americans to lower their cholesterol. U.S. District Judge Joseph J. Farnan ruled that two patents covering atorvastatin, the active ingredient inLipitor, were being infringed upon by a generic version of the drug made by Ranbaxy Laboratories Ltd., a major pharmaceutical manufacturer in India. Pfizer's shares soared more than 11 percent in after-hours trading Friday night after news of the court decision was released, and Pfizer's executives hailed the court ruling as a decisive legal win. Last year, Lipitor rang up sales of $10.9 billion, representing more than 20 percent of Pfizer's worldwide revenues of $52.5 billion. Ranbaxy officials said Friday that they will appeal the federal court decision. Pfizer brought the lawsuit late last year against Ranbaxy after the Indian generic drug manufacturer attempted to market its own version of the global blockbuster, which is now sold in more than 70 countries. Ranbaxy is India's largest pharmaceutical company. The ruling in U.S. District Court in Wilmington, Del., is the second decisive victory for Pfizer as it battlesRanbaxy's aggressive efforts to market a generic version of Lipitor, the world's most-prescribed pharmaceutical. In October, Ranbaxy lost a court battle over Lipitor's patents in England. With Friday's U.S. ruling, Lipitor's exclusivity is protected until June 2011. "Today marks a major victory for medical innovators and the patients who depend on them for important new therapies," said Hank McKinnell, Pfizer's chairman and chief executive officer. McKinnell hailed the second Pfizer victory over Ranbaxy, saying "we will continue to defend against any and all patent challenges that seek to undermine our mission of finding new therapeutic innovations for the patients we serve." Pfizer, the world's largest pharmaceutical company, must protect its drugs' unique chemistry and sales from generic competitors looking to siphon off sales, McKinnell said. New York-based Pfizer has substantial operations in southeastern Connecticut, where it employs about 6,000 people in research, development and manufacturing. Lipitor was first introduced in 1997 and was marketed by the former Warner-Lambert of Morris Plains, N.J., which Pfizer acquired in 2000. Some industry analysts believed Lipitor was a major incentive for Pfizer to grab Warner-Lambert and add the cholesterol medicine to its growing stable of "blockbuster drugs," those with sales of more than $1 billion.

Industry analysts have been closely following Ranbaxy's challenges to Lipitor's patents, and most have assumed that Pfizer, which has deep pockets and top legal talent, would prevail. Many of the industry's largest pharmaceutical companies, dubbed "Big Pharma" by analysts, have been hampered by industry worries over patent expirations as well as growing challenges of some of their existing patents by aggressive generic manufacturers. Pfizer has already invested more than $800 million into research and development for Lipitor, and its extensive testing has involved more than 80,000 patients worldwide. "No generic company would make this commitment, and research- based companies would have no incentive to pursue this work without a stable patent system," said Jeffrey B. Kindler, Pfizer's vice chairman and top legal counsel. Next year, Pfizer expects to spend about $7.6 billion on research and development, an industry record. A substantial amount of that R&D spending would likely end up at its research and development campuses in southeastern Connecticut. Pfizer's worldwide R&D headquarters is based in New London.

(The Day, New London, Conn Dec 17 2005)

Branded and generic drugs companies could be more willing to compromise on IP rights, after Pfizer and Ranbaxy settled most of their multi-billion dollar worldwide litigation over patents for the drug Lipitor on June 18. The battle began when Ranbaxy challenged Pfizer's Lipitor patents in August 2003 and said that extensions to the patents were obtained to fend off generic versions. Cholesterol drug Lipitor is one of the largest-selling prescription drugs with worldwide sales in 2007 of $12.7 billion. Under the agreement, Ranbaxy retains 180-day exclusive rights to sell generic versions of Lipitor in the US from November 30 2011. The Indian company also has a licence to sell generic versions of Lipitor and the fixed-dose combination of atorvastatin-amlodipine besylate (Caduet) in the US from November 30 2011. Ranbaxy can sell generic versions of Lipitor on varying dates in an additional seven countries: Canada, Belgium, the Netherlands, Germany, Sweden, Italy and Australia. The settlement also resolves additional patent litigation between the companies involving the branded drugs Accupril (US) and Viagra (Ecuador) and all patent litigation relating to the generic formulation of quinapril hydrochloride in the United States and sildenafil in Ecuador. However, litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five European countries Finland, Spain, Portugal, Denmark and Romania. "It is obviously a big deal. This is the biggest drug out there. It shows that pharma companies and generics are more willing to compromise on IP and that a settlement is a route both parties want to pursue. Given the stakes on both sides it was expected," said Jonathan Singer, a principal at Fish & Richardson. David Wilson, a partner at Herbert Smith in London who is not involved in the litigation, said that the deal looks good for Pfizer as it extends the company's monopoly past the basic compound patent. "Given the bigger stakes it was favourable to do it. I think what drove this was the US market which is this still the largest market for this product," he added. Ranbaxy has already agreed three settlements in the past year; with AstraZeneca (Nexium) , Astellas Boehringer (Flomax) and GlaxoSmithKline (Valtrex).

~~~~~~~~ By Eklavya Gupte, London

Ranbaxy set for takeover

Within a few days of the settlement being agreed, Japanese pharmaceutical company DaiichiSankyo bought a controlling stake in Ranbaxy. In a transaction expected to be worth $3.4 billion to $4.6 billion, Daiichi-Sankyo will buy the 34.8% stake in Ranbaxy held by the family of Malvinder Mohan Singh, chief executive and managing director of Ranbaxy. The Japanese company will also launch a tender offer to buy up to 20% of Ranbaxy from the market.
Pfizer Inc. and Dr. Reddy's Laboratories Ltd. said Wednesday they settled litigation surrounding the patents for Pfizer's blockbuster cholesterol drug Lipitor.

The companies said the terms of the agreement are confidential. The agreement is subject to review by the U.S. Justice Department and Federal Trade Commission, Dr. Reddy's said. Dr. Reddy's announced the settlement in a press release, and a Pfizer spokesman confirmed the news. Lipitor is set to lose U.S. market exclusivity in November, triggering the availability of cheaper generic versions of the best-selling drug in the world, which will erode sales of the branded drug. Lipitor had 2010 sales of $10.7 billion globally and $5.3 billion in the U.S. In 2009, Dr. Reddy's filed for U.S. Food and Drug Administration approval to sell a generic version of Lipitor, and asserted that certain Pfizer patents for Lipitor were invalid. Pfizer filed a patent-infringement lawsuit against Dr. Reddy's in federal court in Delaware, seeking to block the generic while the patents were still in force. The companies on Aug. 26 filed a joint motion to dismiss the litigation, saying they entered an agreement to resolve it, according to court records. A U.S. judge granted the motion Monday. Pfizer previously settled Lipitor patent litigation with Ranbaxy Laboratories Ltd., under which Ranbaxy is to begin selling generic Lipitor in the U.S. on Nov. 30. Also, Pfizer has granted permission to Watson Pharmaceuticals Inc. to begin selling an "authorized" generic version of Lipitor in November. Under U.S. law, Ranbaxy is due to receive a 180-day period of exclusivity as the only thirdparty provider of generic Lipitor because Ranbaxy was the first to file for FDA approval of a generic version of Lipitor and to challenge the Lipitor patents. Watson also would be permitted to sell its authorized version during this period. However, there has been some uncertainty about whether Ranbaxy will be in a position to begin selling its product Nov. 30 because it is under scrutiny by the FDA for certain manufacturing problems.

Business and Maanagement - Sept 2011Dow Jones DBR High Yield Jun. 19--MUMBAI, India -- Ranbaxy Laboratories has entered into an agreement with Pfizer Inc, to settle most of the patent litigation worldwide involving Atorvastatin (Lipitor), the world's most-prescribed cholesterol-lowering medicine. This decision will allow for an earlier introduction of a generic formulation that will benefit patients and many healthcare systems throughout the world. Lipitor is the world's largest selling drug with worldwide sales of $12.7 billion in 2007. The agreement pertains solely to Ranbaxy and its affiliates and does not cover legal challenges to the Lipitor patents involving other generic manufacturers. However, as Ranbaxy was the first generic challenger to the listed Lipitor patents, it retains the right to the marketing exclusivity of 180 days in the US. Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of Atorvastatin and the fixed-dose combination of Atorvastatin-Amlodipine besylate in the US effective Nov 30, 2011. "This comprehensively settles outstanding issues between Ranbaxy and Pfizer bringing to closure a number of ongoing patent disputes. It also provides certainty and visibility to the launch of Ranbaxy's generic Atorvastatin, with l80 day market exclusivity in the US and an early entry in other markets. This will make the world's largest selling drug more accessible to patients who will gain from the timely availability of an affordable quality option," said Malvinder Mohan Singh, CEO and MD of Ranbaxy Laboratories. Ranbaxy will also have a license to sell Atorvastatin on varying dates in an additional seven countries, including Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia, Brunei, Peru and Vietnam. In addition, the lawsuits between Pfizer and Ranbaxy regarding Atorvastatin will be dismissed in select countries and the lawsuits between Pfizer and Ranbaxy regarding the fixed dose combination product containing Atorvastatin and amlodipine will be dismissed in the US and Ranbaxy will no longer contest the validity of Pfizer's patents in such countries. Such patent challenges by Ranbaxy regarding Lipitor have been underway in numerous markets since 2003. The Atorvastatin patents involved in this agreement are the basic compound patent, which expires in the US in 2010; the enantiomer patent, which expires in 2011; and various processes, and crystalline form patents, which expire in 2016 and 2017; and the combination patent for fixed-dose combination product which expires in 2018. The agreement also covers the fixed-dose combination of Atorvastatin-Amlodipine besylate, a fixed-dose combination product indicated for patients suffering from both high blood pressure and high levels of cholesterol. The patent for the fixed-dose combination expires in 2018. The settlement also resolves additional patent litigation between the companies involving the branded drugs Accupril (in the US) and Viagra (in Ecuador) and all patent

litigation with Ranbaxy relating to generic formulation of Quinapril hydrochloride in the United States and Sildenafil in Ecuador. Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -- Finland, Spain, Portugal, Denmark and Romania. Credit: The Economic Times, India

Ranbaxy, Pfizer settle Lipitor litigation worldwide

Anonymous. McClatchy - Tribune Business News [Washington] 19 June 2008.

Patents; Ranbaxy and Pfizer Settle Lipitor Litigation Worldwide 564 words 4 July 2008 Drug Week DRGW 2370 English (c) Copyright 2008, Drug Week via NewsRx.com 2008 JUL 4 - (NewsRx.com) -- Ranbaxy Laboratories Limited (Ranbaxy), announced that it has entered into an agreement with Pfizer Inc. to settle most of the patent litigation worldwide involving Atorvastatin (Lipitor), the world's most-prescribed cholesterol-lowering medicine. This decision will allow for an earlier introduction of a generic formulation that will benefit patients and many healthcare systems throughout the world. Lipitor is the world's largest selling drug with worldwide sales in 2007 of $12.7 billion. The agreement pertains solely to Ranbaxy and its affiliates and does not cover legal challenges to the Lipitor patents involving other generic manufacturers. However, as Ranbaxy was the first generic challenger to the listed Lipitor patents, it retains the right to the marketing exclusivity of 180 days in the United States. Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of Atorvastatin and the fixed-dose combination of Atorvastatin-Amlodipine besylate in the United States effective Nov. 30, 2011. Welcoming the development, Malvinder Mohan Singh, CEO and MD, Ranbaxy Laboratories Ltd., said, "This comprehensively settles outstanding issues between Ranbaxy and Pfizer bringing to closure a number of ongoing patent disputes. It also provides certainty and visibility to the launch of Ranbaxy's Generic Atorvastatin, with 180-day market exclusivity in the US and an early entry in other markets. This will make the worlds largest selling drug more accessible to patients who will gain from the timely availability of an affordable quality option." Ranbaxy will also have a license to sell Atorvastatin on varying dates in an additional 7 countries, including: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia, Brunei, Peru and Vietnam. In addition, the lawsuits between Pfizer and Ranbaxy regarding Atorvastatin will be dismissed in select countries and the lawsuits between Pfizer and Ranbaxy regarding the

fixed dose combination product containing Atorvastatin and amlodipine will be dismissed in the U.S. and Ranbaxy will no longer contest the validity of Pfizer's patents in such countries. Such patent challenges by Ranbaxy regarding Lipitor have been underway in numerous markets since 2003. The Atorvastatin patents involved in this agreement are the basic compound patent, which expires in the United States in 2010; the enantiomer patent, which expires in the United States in 2011; and various process and crystalline form patents, which expire in 2016 and 2017; and the combination patent for fixed-dose combination product which expires in 2018. The agreement also covers the fixed-dose combination of Atorvastatin-Amlodipine besylate (presently marketed under the brand Caduet, which also contains crystalline Form I Atorvastatin), a fixed-dose combination product indicated for patients suffering from both high blood pressure and high levels of cholesterol. The patent for the fixed-dose combination expires in 2018. The settlement also resolves additional patent litigation between the companies involving the branded drugs Accupril (in the U.S.) and Viagra (in Ecuador) and all patent litigation with Ranbaxy relating to generic formulation of Quinapril hydrochloride in the United States and Sildenafil in Ecuador. Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -- Finland, Spain, Portugal, Denmark and Romania. This article was prepared by Drug Week editors from staff and other reports. Copyright 2008, Drug Week via NewsRx.com.

It has pursued deals with health insurers and pharmacy benefits managers, undercut generic prices and started selling directly to patients online. (Rappeport, Alan. Financial Times [London (UK)] 06 Dec 2011: 18.)

MUMBAI: Indian pharma companies' quest to make millions from the sale of copycat versions of blockbuster drugs may turn out to be a flop show as innovative companies raise defences to protect their turf. The world's biggest-selling drug is going off patent today in the United States and Ranbaxy Laboratories, India's third-largest company, is still struggling to get approvals from the American regulator. Ranbaxy, which has exclusive rights to the off-patent version of Lipitor, Pfizer's blockbuster cholesterolbusting drug, has built its business model around the generic version of Lipitor and its success rides on how much money it can make on sales of the copycat version of the drug. Till the time of going to the press, there was no word on whether a settlement had been reached and whether Ranbaxy will be able to launch its version of Lipitor soon. As the clock ticked away on Tuesday, and rumours of Ranbaxy's settlement with the US Food and Drug Administration made the rounds, company executives declined comment and huddled together in last-minute confabulations with the US authorities. Arun Sawhney, MD of Ranbaxy, was defiant in an analyst call last week. "A lot of our plans are ready. The reality

will be out soon," he said. ETlearns that officials from the USFDA had re-inspected the pharma major's Tonsa plant in Punjab which supplies key ingredients for atorvastatin, the medical name for Lipitor, indicating a possible settlement. Failure to launch the generic version of Lipitor will devastate the company, which has spent millions of dollars in product development and legal costs. It will also raise a huge question mark over the Indian pharmaceutical industry's capability to generate big bucks out of highvalue products going off patent in the next five years. "Ranbaxy has lost the plot," said Surjit Pal, analyst at Elara Capital, which on Tuesday cut the company's EPS target to Rs 15 from Rs 25. Its report told investors to sell the stock, the second such recommendation on Tuesday after Deutsche Bank. "There is nothing left for Ranbaxy with regards to Lipitor now," said NR Munjal, managing director, In-Swift. 'Pfizer won't let Bestseller Lipitor go away so easily' Munjal's company supplies active pharmaceutical ingredients to Pfizer. The anti-cholesterol Lipitor, which contributed close to $10 billion to Pfizer's revenues, is the world's biggestselling drug and has generated sales of over $131 billion for the American drug giant. No other drug in the history of pharma has achieved similar numbers. "Pfizer will not let this product go away," said the promoter of one of the leading suppliers of Pfizer. But for Indian companies, it was not always supposed to be like this. The end of Lipitor's patent was meant to be a eureka moment for Ranbaxy which had the potential to earn as much as $2.5 billion during the 180-day exclusivity period. It was also supposed to be the high point of the Indian pharma industry's attempts to create cheap versions of high-priced patented drugs in the belief that people will only gravitate towards the cheaper versions. For some time during the past 10 years, this strategy seemed to be working. Aggressive, highpitched marketing by Ranbaxy, Dr Reddy's, Cipla, the noise made by health industry activists over the western pharma industry's alleged high-handedness and skyhigh pricing, and the drug giants' myriad problems and flat-footed behaviour all ensured a high visibility for the domestic industry. India's low costs, an immense reservoir of people with skills and knowhow meant the sky was the limit. The companies could manufacture in India, export the drugs to the world and give a tough fight to multinationals in their home turf. But what they did not count on was the response from multinationals. Pushed to the wall by competitive pressures, grappling with rising costs and facing shareholder ire over the absence of any blockbuster drugs, the pharma industry hit back in the only way it could. It teamed up with other generic firms and took the battle to the Indian companies' turf. Last year, Pfizer licensed the Lipitor rights to Watson Pharma, allowing it to sell the authorised generic version of the drug. The deal will allow Pfizer to share up to 70% of the drug's revenue. "Pfizer is going to have the cake and eat it too, it is not letting the product go away to generic pharma companies," said a promoter, whose company is a big supplier to Pfizer. The fight over Lipitor has been no less than a Bollywood thriller: a high-profile court battle lasting three years finally ended in 2008 with a settlement between Pfizer and Ranbaxy. The

settlement delayed the launch of the generic Lipitor to November 30, buying the American company some breathing space. But after three years of high-voltage drama and many twists and turns, Ranbaxy's fortunes, many believe, are starting to decline. Deutsche Bank, in its latest report, has advised a 'sell' with target price of Rs 245. Elara Capital has also advised a 'sell' with the target price of Rs 350. Ranbaxy shares ended 0.66% up at Rs 452.35. Copyright Bennett, Coleman & Company Limited Nov 30, 2011 (Rajagopal, Divya. The Economic Times (Online) [New Delhi] 30 Nov 2011.

INDIA'S RANBAXY WON THE RIGHT TO MAKE A GENERIC VERSION OF THE $11 BILLION DRUG--ONLY TO BE ACCUSED OF SERIOUS FRAUD AND SHODDY PRACTICES IN ANOTHER CASE. NOW A FIGHT IS ERUPTING OVER THE MEGAPOPULAR CHOLESTEROL MEDICATION. JUST AFTER THANKSGIVING THIS YEAR, if all goes as planned, the pharmaceutical industry will pass a historic milestone: A generic version of Lipitor--the biggest-selling prescription drug on the face of the earth--will go on sale for the first time in the U.S. You'd think that in this era of generic-drug dominance, making the transition to a nonbranded version of Pfizer's vaunted cholesterol-fighting statin would be smooth, or at least controlled. And indeed, that's precisely how it seemed--until just a few months ago. Now the process appears to have unraveled, leaving serious questions about who will make the cheaper form of Lipitor, whether the price will really drop, and most disturbing of all, whether patients will be able to trust that the medication is safe. As of today, Ranbaxy, India's largest pharma company and the 12th-largest generics maker in the world, is expected to launch generic atorvastatin calcium, as the molecule is formally known, in the U.S. market on Nov. 30. Under federal rules, Ranbaxy would enjoy six (very profitable) months in which it would have the exclusive right to sell it. The problem: The Food and Drug Administration has accused Ranbaxy of "a pattern of systemic fraudulent conduct" over a period of years. According to the federal agency, Ranbaxy fabricated data in drug applications, took shortcuts in crucial quality tests, and violated a raft of additional manufacturing standards. So widespread and grave was the misbehavior that in 2008 the FDA barred Ranbaxy from importing 30 different drug products into the U.S. That ban remains in place today. Meanwhile, federal prosecutors have been negotiating a criminal and civil settlement with the company that could lead to fines and payments exceeding $1 billion, Fortune has learned from sources with knowledge of the negotiations. Ranbaxy declined to comment for this article, as did the FDA. But in court filings and financial statements, the company, whose leading products in the U.S. are generic versions of Valtrex (for herpes), Aricept (an Alzheimer's drug), and Zocor (another cholesterol medication), has denied misconduct and asserted that it has cooperated fully with the government.

The result of the uncertainty about Ranbaxy and Lipitor has been market mayhem. Genericdrug companies are now feuding like greedy relatives at Lipitor's graveside as they wait to see whether Ranbaxy will maintain its status as front-runner. In March, Mylan, one of the seven generic-drug makers hoping to sell Lipitor, sued the FDA, alleging that the agency's "indecision" and delay had made planning all but impossible. A group of five U.S. senators has appealed to the FDA for clarity. In early March they wrote to the agency's commissioner, demanding timely information on who will be making generic Lipitor and when. The FDA, for its part, has made no public statements on Lipitor's fate. It has yet to formally approve or deny Ranbaxy's application to sell the generic. The Lipitor stalemate is the culmination of the twisting saga of Ranbaxy, which continues to prepare for its product debut, despite the uncertainty as to whether it will occur. "For Ranbaxy, this is the fight of their lives," says a lawyer for a pharma company. "This is the biggest generic opportunity in history. None of us know where this is going to come out." IN THE U.S., DECIDING WHICH company gets to make the first generic version of a drug is a complex process that combines private litigation and government regulation. It's governed by the federal Hatch-Waxman Act. That law, which dates to 1984, created a pathway, the Abbreviated New Drug Application, for companies that want to sell a generic version of a particular medication. Known by its acronym, the ANDA requires two simultaneous steps for any company that wants to be the first to sell a generic. That company must challenge the brand-name company in court and demonstrate that the various patents covering the original drug have run their course or are otherwise not valid. At the same time, the applicant must undergo a formal FDA review to see whether the proposed generic is the biological equivalent of the original and will achieve a similar level of concentration in the blood. The FDA also has to ascertain that the generics company is capable of manufacturing the medication in commercial quantities. The reward for winning this arduous two-front war is six months of exclusive rights to sell the generic. During that period the winner will typically charge 70% to 80% of the brandname price. After that, competitors are permitted to jump in, and the price usually drops to about 5% of the original drug's. For generics manufacturers, being first can be the difference between making a fortune and making a living. (Indeed, six months of exclusive rights to atorvastatin will generate about $600 million in profits for Ranbaxy, according to analyst projections. This for a company with $1.9 billion in revenue and $459 million in earnings in 2010.) Getting first-to-file status has become so important that generic-drug executives have actually been known to sleep overnight in their cars in the FDA parking lot to make sure they're the first to file the paperwork. So it went with Ranbaxy in a process that stretches back all the way to 2003--a time when the company was little known in the U.S. and anything but an obvious choice as the first to take on a blockbuster. That year Ranbaxy scientists reported they had developed a generic version of atorvastatin. The next day a company official flew from New Delhi to Washington to file an application with the FDA, as journalist Bhupesh Bhandari recounts in the book The Ranbaxy Story. That made Ranbaxy the first to file, with FDA front-runner status.

Though Wall Street analysts were dismissive at first, Ranbaxy's proposed formulation seemed credible. The company moved aggressively, and its legal maneuvering was deft. It embarked on litigation with a much bigger opponent, Pfizer, that would span the next five years. In June 2008 the companies announced a deal: Pfizer would no longer block Ranbaxy's efforts to sell generic Lipitor in the U.S., as long as Ranbaxy deferred its launch of atorvastatin until Nov. 30, 2011. The timetable extended Pfizer's patent by at least five months. But even this settlement, viewed as definitive at the time, did not resolve the matter. Ranbaxy still needed a green light from the FDA. As this was happening, Pfizer made plans to manufacture its own generic Lipitor, to be distributed by Watson Pharmaceuticals, even as it continues to sell the name-brand version itself. Increasingly, brand-name companies are doing this. Once a drug goes generic, "the brand goes down the tubes in a hurry," says the pharma lawyer. Launching a generic, he says, is a "mitigation strategy." Pfizer's generic could become the beneficiary of Ranbaxy's woes. If the FDA were to block or delay Ranbaxy's generic Lipitor, the Pfizer generic could have the field to itself. It "could negatively impact pricing" for consumers, says Randall Stanicky, a health-care and pharma analyst at Goldman Sachs. Pfizer could sell its generic at the highest possible price, and since Ranbaxy had been the first to apply to the FDA, no other competitor could sell it. That leaves Lipitor users in the odd position of rooting for Ranbaxy, a company with some unsavory history. IN AUGUST 2005, A WHISTLEBLOWER at Ranbaxy contacted the FDA, alleging that the company had committed extensive fraud in its generic-drug applications. The whistleblower's claims raised serious questions about the integrity of Ranbaxy's manufacturing and the safety of its drugs. The ensuing four-year investigation, in which the FDA has teamed with the U.S. Department of Justice, turned up disturbing evidence, according to government filings (though none of the resulting allegations related to Lipitor). Crucial tests to evaluate how quickly drugs degrade, meant to be conducted over a months-long period, were actually performed over just a few days, with the records falsified to conceal that. On certain days quality assurance supervisors who purported to be on-site were absent, and their signatures were falsified. In yet another lapse--this one potentially life-threatening--Ranbaxy risked cross-contamination of penicillin with other drug products by manufacturing them in close proximity. Taken together, these and other forms of deception by Ranbaxy raised the possibility that what the FDA had approved and what patients were ingesting were two different things. FDA inspectors were disturbed by what they found at the company's Paonta Sahib factory in India, where it planned to make generic Lipitor. They were "clearly shocked" that Ranbaxy was "totally flouting the rules," says one congressional investigator who later interviewed the inspectors. ~~~~~~~~ By September 2008 the FDA had issued warning letters to Ranbaxy, describing what it referred to as "significant deficiencies" at Paonta Sahib and Dewas, the company's two

biggest Indian plants. The FDA restricted the company from bringing some 30 drug products from those plants into the U.S. market. It was a severe blow, and Ranbaxy began intensive efforts to reverse the FDA's decision. Even as the agency blocked Ranbaxy from importing the drugs, it did nothing to remove existing stocks of those same medications from U.S. stores, and it permitted the company to sell another 50 drugs that were manufactured at other facilities. Those decisions helped provoke an unusual twist: a congressional investigation of the FDA (which fizzled out after a change in legislative leaders). In February 2009 the FDA took another drastic step: It shut down reviews of all pending or future drug applications from the Paonta Sahib plant, effectively choking off the company's main pipeline into the U.S. market. The FDA imposes the restriction, known as an Application Integrity Policy, in cases where it has confirmed fraudulent activity. Suddenly Ranbaxy's generic-Lipitor application, which relied on Paonta Sahib as the manufacturing site, seemed to be on very shaky ground. Ranbaxy appealed to the FDA for permission to shift the manufacturing location for atorvastatin to its U.S. plant in New Jersey. Since then, Ranbaxy's negotiations with the FDA and the Department of Justice have receded from public view, and the FDA has not yet issued an opinion as to whether it will permit Ranbaxy to make atorvastatin in the U.S. Just before Ranbaxy's regulatory problems burst into public view, in June 2008, Daiichi Sankyo, Japan's third-largest drugmaker, purchased a majority share of the company. Ranbaxy had just won the rights to Lipitor. But within months Japanese executives were stunned to learn the depth and extent of Ranbaxy's woes, according to sources with knowledge of the FDA investigation. Daiichi Sankyo spent $4.6 billion for 63% of Ranbaxy-and a year later wrote down the value of the acquisition by $3.6 billion. A spokesperson for Daiichi Sankyo would say only, "The first-to-file status for atorvastatin was one of many reasons that Ranbaxy was an attractive acquisition for Daiichi Sankyo. However, our standing policy is not to comment on ongoing litigation. We continue to cooperate fully with the FDA to resolve the issues impacting Ranbaxy operations, but we will not speculate on the timing of any resolution or discuss any detail of those discussions." THE POSSIBLE OUTCOMES to the generic-Lipitor mess seem endless. Wall Street analysts map out complex flow charts to rehearse the potential scenarios and their market impact. Will the FDA allow Ranbaxy to launch atorvastatin in November? Might Ranbaxy cede its rights to the drug so that it can seal a deal--or do just the opposite and cling to the rights as a bargaining chip? Can Ranbaxy defer its exclusivity period, thereby causing a pileup of generics companies forced to wait until Ranbaxy uses up its 180-day window? Such deferrals were permitted when Ranbaxy filed its application back in 2003, but the law has since changed to a use-it-or-lose-it provision. Because of the Lipitor market's sheer size, the differing scenarios could have repercussions across the entire pharmaceutical industry, from pharmacy benefit management companies to wholesale distributors to drugstore chains to, of course, patients. Meanwhile, Ranbaxy's negotiations to resolve the federal fraud allegations, now three years long, drag on with no end in sight. Among the obstacles: The FDA is insisting on a meaningful settlement, and Ranbaxy is desperate to retain its rights to Lipitor. As this has occurred, Daiichi Sankyo has ushered two Ranbaxy CEOs to the exit and predicted an imminent resolution to the crisis.

The pressure on Ranbaxy is increasing, and Fortune has learned that in March it scheduled, then postponed, a meeting with the feds to resolve the fraud case. Some legislators seem to be growing impatient with the FDA. On March 10 the group of five U.S. senators seeking clarity from the FDA wrote to commissioner Margaret Hamburg, urging her to resolve "outstanding regulatory issues that may delay entry of generic versions of this medication." The letter focused on the costs to the government and consumers. Introducing generic Lipitor could save the public up to $6.7 billion a year, the letter states. The senators asked for a response in a week. So far they've received goodwill phone calls but no formal reply. Soon after the senators' letter, on March 21, Mylan, a generic-drug maker with headquarters in West Virginia, filed a lawsuit against the FDA in federal court in Washington, D.C. The company alleges that the FDA's foot-dragging has hampered its efforts to plan its own generic-Lipitor launch. "FDA's indecision is permitting Ranbaxy to maintain a benefit to which it otherwise is not entitled," the complaint charges, requesting that the FDA deny Ranbaxy the exclusive rights to generic Lipitor. The FDA responded on April 4 with a hard-hitting motion to dismiss Mylan's suit. The agency defended its silence, arguing that it is under no obligation to disclose confidential deliberations or to help Mylan with its business planning. Furthermore, the FDA noted that it was unclear whether the FDA would even approve Mylan's application to sell the generic. A judge was expected to rule on the motion to dismiss the case in early May. Investors interpreted the FDA's stance in the Mylan case as a hint that the agency was planning to allow Ranbaxy to sell atorvastatin in November. The Indian company's shares rose on the news. It may indeed turn out that way, but with Ranbaxy still trying to hammer out its giant settlement, the only certainty is that there will be a few more twists and turns along the way. + FEEDBACK letters@fortunemail.com
LIPITOR'S PROFILE

U.S. SALES, 2010: $5.3 billion NUMBER OF U.S. PRESCRIPTIONS: 45 million NON-U.S. SALES, 2010: $5.4 billion NUMBER OF COUNTRIES IN WHICH IT IS SOLD: 119 PEAK SALES (2006): $13 billion SOURCES: IMS HEALTH, PFIZER PHOTO (COLOR): Immediate Impact The market share of a name-brand drug crashes once a generic version goes on sale, as data from 2010 demonstrate. MARKET SHARE OF NAMEBRAND DRUGS BRAND SHARES INCLUDE LINE EXTENSIONS SOURCE IMS HEALTH, NATIONAL PRESCRIPTION AUDIT PLUS, FEBRUARY 2011

PHOTO (COLOR): Ranbaxy's research lab in Gurgoan, India. Products from two other Indian facilities were banned from sale in the U.S. PHOTO (COLOR) PHOTO (COLOR) PHOTO (COLOR) ~~~~~~~~ By KATHERINE EBAN KATHERINE EBAN, a Fortune contributor, has also written for Vanity Fair, the New York Times, and Self magazine. Her most recent article for Fortune was "Drug Theft Goes Big," in the April 11, 2011, issue. (EBAN, K. (2011). THE WAR OVER LIPITOR. Fortune, 163(7), 204-210. ) I have interest in adventure sports and mountain photography. During my exchange term, I went all they way to the Arctic Circle, alone, out of adventure. I also enjoy mountain biking, jet skiing, para sailing, rock climbing, via ferrata, deep sea diving, water skiing.

I enjoy dance and am proficient in hip hop, contemporary and several ball room styles.

I have been a part of the cricket, football, basketball, table tennis, volleyball teams all throughout my life.

I have interest in Philosophy, in particular Jain and western philosophy.

I am proficient in Research, which is evident from my academic paper competitions and the papers I wrote during my exchange term. I also have a good knack of planning which I developed during my travel expeditions during my exchange trip. 1) Initiated a new business model and confirmed future business with two clients with one business being executed, immediately after my internship.

2) Sold 150 Cafe Moments Card ( Loyalty Program) to a company as a corporate gifting solution.

3) Was the Marketing Head of Pressbox, the editorial committee of NMIMS.

4) Won 2nd Prize in the Article Writing Competition on Marketing and 2nd Prize in a Dance Competition. 1) Won 2nd Prize in Paper Presentation competition at UICT. Won 2nd Prize in debate competition.

2) Won the Best Performance for my Dance performance and my choreographed routine helped my class to win the best group dance prize.

3) Was captain of the football team.

4) Was a topper in Organic Chemistry in the first year.