India’s largest drug-maker, Ranbaxy, has locked horns with the US-based world’s largest drug-maker

Pfizer in 17 countries over infringement of patent of the latter’s blockbuster cholesterol-lowering drug Lipitor. The company’s 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 world’s largest selling drug with sales worth about US$13 billionin 2006. The patent for Lipitor expires in 2010. During 2004–2005, Ranbaxy had to reportedly shell out around Rs 160 crore (US$3.69 million) to fight against Pfizer’s 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.

Italy and Australia. Pfizer has already invested more than $800 million into research and development for Lipitor. would prevail. a partner at Herbert Smith in London who is not involved in the litigation. 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. 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. Germany. Ranbaxy has already agreed three settlements in the past year. Under the agreement.7 billion. Ranbaxy retains 180-day exclusive rights to sell generic versions of Lipitor in the US from November 30 2011. Pfizer's vice chairman and top legal counsel. the Netherlands. David Wilson. and research. have been hampered by industry worries over patent expirations as well as growing challenges of some of their existing patents by aggressive generic manufacturers. "It is obviously a big deal. This is the biggest drug out there.based companies would have no incentive to pursue this work without a stable patent system. after Pfizer and Ranbaxy settled most of their multi-billion dollar worldwide litigation over patents for the drug Lipitor on June 18. Given the stakes on both sides it was expected. (The Day. and its extensive testing has involved more than 80. New London. 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. A substantial amount of that R&D spending would likely end up at its research and development campuses in southeastern Connecticut. Belgium. a principal at Fish & Richardson. with AstraZeneca (Nexium) . and most have assumed that Pfizer. "No generic company would make this commitment. I think what drove this was the US market which is this still the largest market for this product. Cholesterol drug Lipitor is one of the largest-selling prescription drugs with worldwide sales in 2007 of $12. "Given the bigger stakes it was favourable to do it.Industry analysts have been closely following Ranbaxy's challenges to Lipitor's patents. Ranbaxy can sell generic versions of Lipitor on varying dates in an additional seven countries: Canada. which has deep pockets and top legal talent. Many of the industry's largest pharmaceutical companies. Astellas Boehringer (Flomax) and GlaxoSmithKline (Valtrex). litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five European countries — Finland. However. Pfizer's worldwide R&D headquarters is based in New London." said Jonathan Singer. said that the deal looks good for Pfizer as it extends the company's monopoly past the basic compound patent. Denmark and Romania. Next year. an industry record. . Pfizer expects to spend about $7. Kindler." said Jeffrey B. Conn – Dec 17 2005) Branded and generic drugs companies could be more willing to compromise on IP rights. dubbed "Big Pharma" by analysts. Sweden. 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.000 patients worldwide." he added. Portugal. Spain.6 billion on research and development.

according to court records. The companies on Aug. Reddy's Laboratories Ltd. Lipitor is set to lose U. A U. Under U. said Wednesday they settled litigation surrounding the patents for Pfizer's blockbuster cholesterol drug Lipitor. However.4 billion to $4.S. to begin selling an "authorized" generic version of Lipitor in November.8% stake in Ranbaxy held by the family of Malvinder Mohan Singh. The Japanese company will also launch a tender offer to buy up to 20% of Ranbaxy from the market. saying they entered an agreement to resolve it. and Dr. The companies said the terms of the agreement are confidential. under which Ranbaxy is to begin selling generic Lipitor in the U.S. Reddy's said.S. 30 because it is under scrutiny by the FDA for certain manufacturing problems.~~~~~~~~ By Eklavya Gupte. Pfizer previously settled Lipitor patent litigation with Ranbaxy Laboratories Ltd. In 2009. In a transaction expected to be worth $3.7 billion globally and $5. Lipitor had 2010 sales of $10.S. Food and Drug Administration approval to sell a generic version of Lipitor. Reddy's in federal court in Delaware. seeking to block the generic while the patents were still in force. Daiichi-Sankyo will buy the 34.S. Dr. chief executive and managing director of Ranbaxy. and asserted that certain Pfizer patents for Lipitor were invalid. Watson also would be permitted to sell its authorized version during this period. London Ranbaxy set for takeover Within a few days of the settlement being agreed. Also. which will erode sales of the branded drug. Pfizer filed a patent-infringement lawsuit against Dr. .S. Japanese pharmaceutical company DaiichiSankyo bought a controlling stake in Ranbaxy. Dr.S. Reddy's filed for U. triggering the availability of cheaper generic versions of the best-selling drug in the world. 26 filed a joint motion to dismiss the litigation. there has been some uncertainty about whether Ranbaxy will be in a position to begin selling its product Nov.. 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. Dr. on Nov.6 billion. Pfizer Inc. law. The agreement is subject to review by the U. and a Pfizer spokesman confirmed the news.3 billion in the U. 30. market exclusivity in November. Reddy's announced the settlement in a press release. Justice Department and Federal Trade Commission. Pfizer has granted permission to Watson Pharmaceuticals Inc. judge granted the motion Monday.

Lipitor is the world's largest selling drug with worldwide sales of $12. 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. CEO and MD of Ranbaxy Laboratories. The patent for the fixed-dose combination expires in 2018. The agreement also covers the fixed-dose combination of Atorvastatin-Amlodipine besylate. which expire in 2016 and 2017. which expires in 2011. Netherlands." said Malvinder Mohan Singh. Sweden. 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 . a fixed-dose combination product indicated for patients suffering from both high blood pressure and high levels of cholesterol. The agreement pertains solely to Ranbaxy and its affiliates and does not cover legal challenges to the Lipitor patents involving other generic manufacturers. Peru and Vietnam. Under the terms of the agreement. and crystalline form patents. The Atorvastatin patents involved in this agreement are the basic compound patent. the world's most-prescribed cholesterol-lowering medicine. Germany.7 billion in 2007. the enantiomer patent. 2011. It also provides certainty and visibility to the launch of Ranbaxy's generic Atorvastatin. as Ranbaxy was the first generic challenger to the listed Lipitor patents.Business and Maanagement . 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. "This comprehensively settles outstanding issues between Ranbaxy and Pfizer bringing to closure a number of ongoing patent disputes. Italy and Australia. In addition. However.Sept 2011Dow Jones DBR High Yield Jun. and the combination patent for fixed-dose combination product which expires in 2018. Ranbaxy will also have a license to sell Atorvastatin on varying dates in an additional seven countries. 19--MUMBAI. This decision will allow for an earlier introduction of a generic formulation that will benefit patients and many healthcare systems throughout the world.Ranbaxy Laboratories has entered into an agreement with Pfizer Inc. to settle most of the patent litigation worldwide involving Atorvastatin (Lipitor). and various processes. 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. Brunei. it retains the right to the marketing exclusivity of 180 days in the US. with l80 day market exclusivity in the US and an early entry in other markets. including Canada. which expires in the US in 2010. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia. India -. Belgium. Such patent challenges by Ranbaxy regarding Lipitor have been underway in numerous markets since 2003.

Portugal. The agreement pertains solely to Ranbaxy and its affiliates and does not cover legal challenges to the Lipitor patents involving other generic manufacturers. Pfizer settle Lipitor litigation worldwide Anonymous. Ranbaxy Laboratories Ltd. Credit: The Economic Times.. Malvinder Mohan Singh. the lawsuits between Pfizer and Ranbaxy regarding Atorvastatin will be dismissed in select countries and the lawsuits between Pfizer and Ranbaxy regarding the . Brunei. with 180-day market exclusivity in the US and an early entry in other markets. 2011. including: Canada. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia. Italy and Australia. announced that it has entered into an agreement with Pfizer Inc. Under the terms of the agreement. Lipitor is the world's largest selling drug with worldwide sales in 2007 of $12. Patents. However.7 billion. In addition.(NewsRx. "This comprehensively settles outstanding issues between Ranbaxy and Pfizer bringing to closure a number of ongoing patent disputes. Germany. 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 and Pfizer Settle Lipitor Litigation Worldwide 564 words 4 July 2008 Drug Week DRGW 2370 English (c) Copyright 2008. Spain. said. This decision will allow for an earlier introduction of a generic formulation that will benefit patients and many healthcare systems throughout the world. Peru and Vietnam. Drug Week via NewsRx.Finland.com) -. as Ranbaxy was the first generic challenger to the listed Lipitor patents.com 2008 JUL 4 . Welcoming the development. Denmark and Romania." Ranbaxy will also have a license to sell Atorvastatin on varying dates in an additional 7 countries. McClatchy . 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. the world's most-prescribed cholesterol-lowering medicine.Tribune Business News [Washington] 19 June 2008. it retains the right to the marketing exclusivity of 180 days in the United States. It also provides certainty and visibility to the launch of Ranbaxy's Generic Atorvastatin. Sweden. 30. Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -. Belgium. Netherlands.litigation with Ranbaxy relating to generic formulation of Quinapril hydrochloride in the United States and Sildenafil in Ecuador. CEO and MD. to settle most of the patent litigation worldwide involving Atorvastatin (Lipitor).Ranbaxy Laboratories Limited (Ranbaxy). India Ranbaxy.

"A lot of our plans are ready.) 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. which also contains crystalline Form I Atorvastatin). (Rappeport. Financial Times [London (UK)] 06 Dec 2011: 18. the enantiomer patent. Denmark and Romania. The world's biggest-selling drug is going off patent today in the United States and Ranbaxy Laboratories. Portugal. which expires in the United States in 2010. 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. Pfizer's blockbuster cholesterolbusting drug. which expires in the United States in 2011. The Atorvastatin patents involved in this agreement are the basic compound patent. Arun Sawhney. The reality . The patent for the fixed-dose combination expires in 2018. Such patent challenges by Ranbaxy regarding Lipitor have been underway in numerous markets since 2003. there was no word on whether a settlement had been reached and whether Ranbaxy will be able to launch its version of Lipitor soon. and Ranbaxy will no longer contest the validity of Pfizer's patents in such countries. The settlement also resolves additional patent litigation between the companies involving the branded drugs Accupril (in the U. Copyright 2008. It has pursued deals with health insurers and pharmacy benefits managers. India's third-largest company. and rumours of Ranbaxy's settlement with the US Food and Drug Administration made the rounds. MD of Ranbaxy.S. As the clock ticked away on Tuesday. The agreement also covers the fixed-dose combination of Atorvastatin-Amlodipine besylate (presently marketed under the brand Caduet.fixed dose combination product containing Atorvastatin and amlodipine will be dismissed in the U. undercut generic prices and started selling directly to patients online. Alan. company executives declined comment and huddled together in last-minute confabulations with the US authorities. and the combination patent for fixed-dose combination product which expires in 2018. which expire in 2016 and 2017. Drug Week via NewsRx.Finland. and various process and crystalline form patents. This article was prepared by Drug Week editors from staff and other reports. Ranbaxy.) 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. a fixed-dose combination product indicated for patients suffering from both high blood pressure and high levels of cholesterol. is still struggling to get approvals from the American regulator. Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -. was defiant in an analyst call last week. Spain. Till the time of going to the press.com. which has exclusive rights to the off-patent version of Lipitor.S.

it was not always supposed to be like this. No other drug in the history of pharma has achieved similar numbers." said Surjit Pal. 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. But what they did not count on was the response from multinationals. It teamed up with other generic firms and took the battle to the Indian companies' turf." said a promoter. managing director." he said. analyst at Elara Capital. 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. Pushed to the wall by competitive pressures. whose company is a big supplier to Pfizer. 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. allowing it to sell the authorised generic version of the drug. an immense reservoir of people with skills and knowhow meant the sky was the limit. the medical name for Lipitor. The ." said NR Munjal. the noise made by health industry activists over the western pharma industry's alleged high-handedness and skyhigh pricing. this strategy seemed to be working. For some time during the past 10 years. Its report told investors to sell the stock. The anti-cholesterol Lipitor. Pfizer licensed the Lipitor rights to Watson Pharma. "There is nothing left for Ranbaxy with regards to Lipitor now. 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. it is not letting the product go away to generic pharma companies. "Ranbaxy has lost the plot. Dr Reddy's. 'Pfizer won't let Bestseller Lipitor go away so easily' Munjal's company supplies active pharmaceutical ingredients to Pfizer. indicating a possible settlement. Failure to launch the generic version of Lipitor will devastate the company. the pharma industry hit back in the only way it could. Cipla. which has spent millions of dollars in product development and legal costs.5 billion during the 180-day exclusivity period. which contributed close to $10 billion to Pfizer's revenues. Aggressive. "Pfizer is going to have the cake and eat it too. The companies could manufacture in India. which on Tuesday cut the company's EPS target to Rs 15 from Rs 25. Last year. highpitched marketing by Ranbaxy. India's low costs. But for Indian companies. ETlearns that officials from the USFDA had re-inspected the pharma major's Tonsa plant in Punjab which supplies key ingredients for atorvastatin. In-Swift. "Pfizer will not let this product go away. and the drug giants' myriad problems and flat-footed behaviour all ensured a high visibility for the domestic industry. The deal will allow Pfizer to share up to 70% of the drug's revenue. the second such recommendation on Tuesday after Deutsche Bank.will be out soon. export the drugs to the world and give a tough fight to multinationals in their home turf. is the world's biggestselling drug and has generated sales of over $131 billion for the American drug giant. grappling with rising costs and facing shareholder ire over the absence of any blockbuster drugs." said the promoter of one of the leading suppliers of Pfizer.

buying the American company some breathing space. in the U. as the molecule is formally known. many believe. if all goes as planned.66% up at Rs 452. Coleman & Company Limited Nov 30. federal prosecutors have been negotiating a criminal and civil settlement with the company that could lead to fines and payments exceeding $1 billion. and violated a raft of additional manufacturing standards.S. That ban remains in place today. NOW A FIGHT IS ERUPTING OVER THE MEGAPOPULAR CHOLESTEROL MEDICATION.S. 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. But in court filings and financial statements. Ranbaxy's fortunes. as did the FDA. is expected to launch generic atorvastatin calcium. and most disturbing of all. in its latest report. 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. Copyright Bennett. But after three years of high-voltage drama and many twists and turns. or at least controlled. Ranbaxy would enjoy six (very profitable) months in which it would have the exclusive right to sell it. 2011 (Rajagopal. and Zocor (another cholesterol medication).35. Aricept (an Alzheimer's drug). are starting to decline. are generic versions of Valtrex (for herpes). 30. Divya.settlement delayed the launch of the generic Lipitor to November 30. the company. whether the price will really drop. making the transition to a nonbranded version of Pfizer's vaunted cholesterol-fighting statin would be smooth. whether patients will be able to trust that the medication is safe. And indeed. Under federal rules. Meanwhile. Elara Capital has also advised a 'sell' with the target price of Rs 350. India's largest pharma company and the 12th-largest generics maker in the world. JUST AFTER THANKSGIVING THIS YEAR. has denied misconduct and asserted that it has cooperated fully with the government. Ranbaxy fabricated data in drug applications. took shortcuts in crucial quality tests. According to the federal agency. As of today. has advised a 'sell' with target price of Rs 245. market on Nov. Ranbaxy declined to comment for this article. . whose leading products in the U. that's precisely how it seemed--until just a few months ago.S. Ranbaxy shares ended 0. Ranbaxy. leaving serious questions about who will make the cheaper form of Lipitor. You'd think that in this era of generic-drug dominance. Now the process appears to have unraveled. So widespread and grave was the misbehavior that in 2008 the FDA barred Ranbaxy from importing 30 different drug products into the U. Deutsche Bank. The problem: The Food and Drug Administration has accused Ranbaxy of "a pattern of systemic fraudulent conduct" over a period of years. The Economic Times (Online) [New Delhi] 30 Nov 2011. Fortune has learned from sources with knowledge of the negotiations.S.

"This is the biggest generic opportunity in history. despite the uncertainty as to whether it will occur. has made no public statements on Lipitor's fate. competitors are permitted to jump in. as journalist Bhupesh Bhandari recounts in the book The Ranbaxy Story. this is the fight of their lives. It has yet to formally approve or deny Ranbaxy's application to sell the generic. The reward for winning this arduous two-front war is six months of exclusive rights to sell the generic. which dates to 1984. the Abbreviated New Drug Application. In March. That made Ranbaxy the first to file. . In early March they wrote to the agency's commissioner. senators has appealed to the FDA for clarity. "For Ranbaxy. The next day a company official flew from New Delhi to Washington to file an application with the FDA. During that period the winner will typically charge 70% to 80% of the brandname price. A group of five U.S. with FDA front-runner status. created a pathway. For generics manufacturers. 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. and anything but an obvious choice as the first to take on a blockbuster. which continues to prepare for its product debut. for companies that want to sell a generic version of a particular medication. 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. The FDA also has to ascertain that the generics company is capable of manufacturing the medication in commercial quantities. After that. The Lipitor stalemate is the culmination of the twisting saga of Ranbaxy." says a lawyer for a pharma company. That year Ranbaxy scientists reported they had developed a generic version of atorvastatin.The result of the uncertainty about Ranbaxy and Lipitor has been market mayhem. and the price usually drops to about 5% of the original drug's. None of us know where this is going to come out. alleging that the agency's "indecision" and delay had made planning all but impossible.S. for its part. Known by its acronym. one of the seven generic-drug makers hoping to sell Lipitor.) 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. according to analyst projections. That law." IN THE U.9 billion in revenue and $459 million in earnings in 2010. demanding timely information on who will be making generic Lipitor and when. (Indeed. 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. It's governed by the federal Hatch-Waxman Act. being first can be the difference between making a fortune and making a living. At the same time. sued the FDA.. 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. six months of exclusive rights to atorvastatin will generate about $600 million in profits for Ranbaxy. This for a company with $1. The FDA. DECIDING WHICH company gets to make the first generic version of a drug is a complex process that combines private litigation and government regulation. Mylan. the ANDA requires two simultaneous steps for any company that wants to be the first to sell a generic.S.

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

Wall Street analysts map out complex flow charts to rehearse the potential scenarios and their market impact.S.6 billion.S. A spokesperson for Daiichi Sankyo would say only. 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. Among the obstacles: The FDA is insisting on a meaningful settlement. Daiichi Sankyo spent $4. Ranbaxy's negotiations with the FDA and the Department of Justice have receded from public view. market. Meanwhile. from pharmacy benefit management companies to wholesale distributors to drugstore chains to. Just before Ranbaxy's regulatory problems burst into public view. but the law has since changed to a use-it-or-lose-it provision. We continue to cooperate fully with the FDA to resolve the issues impacting Ranbaxy operations.biggest Indian plants. in June 2008. purchased a majority share of the company.S. in cases where it has confirmed fraudulent activity.S. Ranbaxy appealed to the FDA for permission to shift the manufacturing location for atorvastatin to its U. Those decisions helped provoke an unusual twist: a congressional investigation of the FDA (which fizzled out after a change in legislative leaders). which relied on Paonta Sahib as the manufacturing site. and it permitted the company to sell another 50 drugs that were manufactured at other facilities. market. The FDA imposes the restriction. and Ranbaxy began intensive efforts to reverse the FDA's decision. 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. our standing policy is not to comment on ongoing litigation. As this has occurred. "The first-to-file status for atorvastatin was one of many reasons that Ranbaxy was an attractive acquisition for Daiichi Sankyo. and the FDA has not yet issued an opinion as to whether it will permit Ranbaxy to make atorvastatin in the U. Because of the Lipitor market's sheer size. Japan's third-largest drugmaker. It was a severe blow.S. The FDA restricted the company from bringing some 30 drug products from those plants into the U." THE POSSIBLE OUTCOMES to the generic-Lipitor mess seem endless. according to sources with knowledge of the FDA investigation. plant in New Jersey. and Ranbaxy is desperate to retain its rights to Lipitor. Daiichi Sankyo has ushered two Ranbaxy CEOs to the exit and predicted an imminent resolution to the crisis. Since then. drag on with no end in sight. patients. of course. Ranbaxy's negotiations to resolve the federal fraud allegations. Even as the agency blocked Ranbaxy from importing the drugs. However. now three years long. But within months Japanese executives were stunned to learn the depth and extent of Ranbaxy's woes. known as an Application Integrity Policy.6 billion for 63% of Ranbaxy-and a year later wrote down the value of the acquisition by $3. seemed to be on very shaky ground. but we will not speculate on the timing of any resolution or discuss any detail of those discussions. effectively choking off the company's main pipeline into the U. 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. stores. the differing scenarios could have repercussions across the entire pharmaceutical industry. it did nothing to remove existing stocks of those same medications from U. Ranbaxy had just won the rights to Lipitor. Suddenly Ranbaxy's generic-Lipitor application. Daiichi Sankyo. .

then postponed.S. Introducing generic Lipitor could save the public up to $6.S. the letter states. "FDA's indecision is permitting Ranbaxy to maintain a benefit to which it otherwise is not entitled.S. 2010: $5. 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 pressure on Ranbaxy is increasing. urging her to resolve "outstanding regulatory issues that may delay entry of generic versions of this medication. Furthermore." the complaint charges. The agency defended its silence. SALES. NATIONAL PRESCRIPTION AUDIT PLUS. PRESCRIPTIONS: 45 million NON-U. a generic-drug maker with headquarters in West Virginia. Some legislators seem to be growing impatient with the FDA. SALES.4 billion NUMBER OF COUNTRIES IN WHICH IT IS SOLD: 119 PEAK SALES (2006): $13 billion SOURCES: IMS HEALTH.S. Soon after the senators' letter. It may indeed turn out that way. So far they've received goodwill phone calls but no formal reply. On March 10 the group of five U. MARKET SHARE OF NAMEBRAND DRUGS BRAND SHARES INCLUDE LINE EXTENSIONS SOURCE IMS HEALTH. + FEEDBACK letters@fortunemail. 2010: $5. as data from 2010 demonstrate. FEBRUARY 2011 . The FDA responded on April 4 with a hard-hitting motion to dismiss Mylan's suit." The letter focused on the costs to the government and consumers. on March 21.3 billion NUMBER OF U. the FDA noted that it was unclear whether the FDA would even approve Mylan's application to sell the generic. PFIZER PHOTO (COLOR): Immediate Impact The market share of a name-brand drug crashes once a generic version goes on sale. arguing that it is under no obligation to disclose confidential deliberations or to help Mylan with its business planning. senators seeking clarity from the FDA wrote to commissioner Margaret Hamburg.com LIPITOR'S PROFILE U. a meeting with the feds to resolve the fraud case. The company alleges that the FDA's foot-dragging has hampered its efforts to plan its own generic-Lipitor launch. The Indian company's shares rose on the news. D.C. the only certainty is that there will be a few more twists and turns along the way. and Fortune has learned that in March it scheduled. A judge was expected to rule on the motion to dismiss the case in early May. Mylan. requesting that the FDA deny Ranbaxy the exclusive rights to generic Lipitor. but with Ranbaxy still trying to hammer out its giant settlement.7 billion a year. filed a lawsuit against the FDA in federal court in Washington. The senators asked for a response in a week.

the New York Times. para sailing. THE WAR OVER LIPITOR. issue. I have been a part of the cricket. I enjoy dance and am proficient in hip hop.S. contemporary and several ball room styles. out of adventure. basketball. I am proficient in Research. football. rock climbing. via ferrata. and Self magazine. which is evident from my academic paper competitions and the papers I wrote during my exchange term. a Fortune contributor. India. has also written for Vanity Fair. 2011. During my exchange term. Her most recent article for Fortune was "Drug Theft Goes Big. in particular Jain and western philosophy. . ) I have interest in adventure sports and mountain photography. 204-210. Products from two other Indian facilities were banned from sale in the U. I went all they way to the Arctic Circle. Fortune.PHOTO (COLOR): Ranbaxy's research lab in Gurgoan. K. 163(7). immediately after my internship. 2) Sold 150 Cafe Moments Card ( Loyalty Program) to a company as a corporate gifting solution. volleyball teams all throughout my life. PHOTO (COLOR) PHOTO (COLOR) PHOTO (COLOR) ~~~~~~~~ By KATHERINE EBAN KATHERINE EBAN. I have interest in Philosophy. table tennis. I also have a good knack of planning which I developed during my travel expeditions during my exchange trip. jet skiing. 1) Initiated a new business model and confirmed future business with two clients with one business being executed. water skiing. alone. I also enjoy mountain biking. (EBAN." in the April 11. deep sea diving. (2011).

the editorial committee of NMIMS. Won 2nd Prize in debate competition. 4) Was a topper in Organic Chemistry in the first year. 4) Won 2nd Prize in the Article Writing Competition on Marketing and 2nd Prize in a Dance Competition. 3) Was captain of the football team. 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 the Marketing Head of Pressbox. 1) Won 2nd Prize in Paper Presentation competition at UICT.