Novartis milestones be proud ! Management take a bow !

Quote
05-03-2012
Novartis Consumer Health initiates product recall

Public Health Announcement

Novartis Consumer Health (NCH) is voluntarily recalling all lots of select bottle sizes of Excedrin® and NoDoz® Alertness Aid products with expiration dates of Dec. 20, 2014 or earlier. Also being recalled are Bufferin® and Gas-X® Prevention® products with expiration dates of Dec. 20, 2013 or earlier, in the United States.

NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules or caplets from other products, or may contain broken or chipped tablets.

A comprehensive recall was initiated as a precautionary measure due to potential product mix-ups and is not based upon adverse events reported in relation to the recalled products.

NCH personnel believe this voluntary action is in the best interest of consumers who trust and rely on the company's products.

Consumers with questions or who have experienced an adverse event are advised to contact their physician or healthcare provider as soon as possible. Consumers should also report the adverse event to the Novartis Consumer Relationship Center at 1-888-477-2403.

As this is a voluntary recall at the consumer level, NCH advises consumers who have purchased these recalled products to discontinue use and return them to NCH for a full refund.

These actions have been communicated to the US Food and Drug Administration (FDA). "We are working closely with the FDA and will continue to do so throughout this process," said a company spokesman.

Additional information may also be found on the FDA website at www.fda.gov and at www.nodoz.com/otc/.

Consumers with questions regarding the recall should contact the Novartis Consumer Relationship Center at 1-888-477-2403, from 8 am until midnight, EST, Monday through Saturday, for information on how to return the affected products and receive reimbursement.
 






FOLDING LIKE A HOUSE OF CARDS !!!!!!!LMAO !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Novartis may weigh Lucentis price cut in U.K.
May 8, 2012 | By Tracy Staton

A one-two punch from new studies has Novartis ($NVS) weighing a price cut on its eye drug Lucentis. Last week, data comparing that product to its close cousin, Avastin, in macular degeneration patients found the two meds roughly equivalent, efficacy-wise. This week, a U.K study concluded that the two offered similar results with a similar safety profile.

That U.K. study also figured the National Health Service could save £85 million annually by using Avastin off-label in those patients, rather than the much-more-expensive Lucentis. Avastin, intended as a cancer treatment, runs about £60 per injection in the U.K., in doses small enough for eye use, InPharm reports. Lucentis costs £750 per dose.

Now, as InPharm reports, the Swiss drugmaker says it's in talks about "the cost effectiveness of Lucentis across all indications" with the U.K.'s National Institute for Health and Clinical Excellence. If those talks go the way of similar negotiations in Switzerland, NICE could well nab a discount. Last fall, the Swiss health minister extracted a 30% price cut on the drug, using earlier head-to-head Avastin data as a talking point.
 






GlaxoSmithKline, Novartis, Eli Lilly face Indian collusion charges

by: Robin Pagnamenta
From: The Times
May 11, 201211:14AM

SOME of the world's biggest drug-makers have been accused of putting lives at risk by colluding with India's medicines regulator to win approval for drugs without expensive human safety trials.

The accusation, was contained in a report this week from India's parliamentary committee on health.

It is one of a series of claims made against global drug groups, including Novartis and Eli Lilly, that suggested that they had "colluded" with India's Central Drugs Standard Control Organisation (CDSCO) to speed lucrative drugs through the approval process.

The 78-page report, the result of an 18-month investigation, strongly criticised the CDSCO. It named 11 drugs, including ambrisentan, which had been licensed for sale in India without Phase III clinical trials - the mass human studies necessary before they can be sold in Europe or the US.

"There is sufficient evidence...to conclude that there is a collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts," the report said.

"Such irregular approvals spare drug producers the cost and efforts, but put Indian patients at risk."

Some medicines are approved for sale in India without local Phase III trials, as such tests have been conducted in other countries. But critics say that this disregards ethnic differences that could make Indian patients more vulnerable to dangerous side-effects.

Yesterday Novartis, whose drugs everolimus and aliskiren were also named in the report, said that it planned to investigate the claims.

India's $US12 billion ($11.93bn) pharmaceutical market is the fourth-largest in the world in volume terms, according to the Organisation of Pharmaceutical Producers of India.

International drug companies are betting heavily on emerging markets to make up for declining revenues and the expiry of patents in the US and Europe.

The report painted a picture of lax regulation over drug licensing in India, and said the CDSCO was chronically under-resourced in a country where about 10,000 drug manufacturers operate.
 






ADDIOS EXFORGIOS BUH BYE

Novartis Sues Lupin, Torrent Over Blood-Pressure Medicine

By Phil Milford and Sophia Pearson on May 14, 2012

Novartis AG (NOVN) sued Lupin Ltd. (LPC) and Torrent Pharmaceuticals Ltd. (TRP) for infringing patents on its Exforge HCT blood-pressure medicine.

Lupin, based in Mumbai, and Torrent, based in Ahmedabad, India, are seeking to make generic versions of the drug before the expiration of two patents. Novartis requested a court order barring the companies from making, using or offering for sale copies of the drugs until the patents have expired, according to complaints filed today in federal court in Wilmington, Delaware.

Novartis, based in Basel, Switzerland, is counting on new products, including Exforge, to help replace revenue lost when the company’s best sellers, Diovan for hypertension and Gleevac for leukemia, start to lose U.S. patent protection later this year and in 2015, respectively. The two Exforge patents in dispute expire in 2017 and 2023, according to U.S. Food and Drug Administration records.

Dawn Chitty, vice president of regulatory affairs at Torrent’s U.S. offices in Kalamazoo, Michigan, said the company doesn’t comment on pending litigation. Edith St-Hilaire, a spokeswoman for Lupin, didn’t immediately return phone and e- mail messages seeking comment on the lawsuit.
 






MORE LAWSUITS AGAINST NOFARTUS ~

Bloomberg News
Merck Sues Sandoz, Intas Over Proposed Generic Copy of Emend
By David Voreacos and Susan Decker on June 05, 2012

Merck & Co. (MRK) (MRK) sued the Sandoz unit of Swiss drugmaker Novartis AG (NOVN) and Intas Pharmaceuticals Ltd. (INTAS) to block them from selling generic forms of Emend, which prevents nausea and vomiting from chemotherapy.

Sandoz, the generic-drug maker, and Intas’s Accord Healthcare unit seek U.S. Food and Drug Administration approval to sell intravenous forms of Emend, according to the lawsuits, filed in federal court in Trenton, New Jersey.

Merck, the second-largest U.S. drugmaker, said the Sandoz and Accord drugs would infringe two patents and seeks a court order to prevent sales until they expire in February 2015 and March 2019. Emend in all forms generated $419 million in sales last year, an 11 percent rise over 2010, Whitehouse Station, New Jersey-based Merck said in its annual report.

The Sandoz case was filed May 31, and the Accord complaint was filed June 1. A spokeswoman for Sandoz had no immediate comment. Samir Mehta, the president of Durham, North Carolina- based Accord, didn’t immediately return a call seeking comment on the lawsuit.

The cases are Merck v. Accord Healthcare, 12-cv-3324 and Merck v. Sandoz Inc., 12-cv-3289, U.S. District Court, District of New Jersey (Trenton).
 






THE QUALITY IS IMPRESSIVE, THINK WHAT'S POSSIBLE ! UNWANTED PREGNANCIES!!!
ALL DUE TO A COMPANY CALLED NOFARTUS , THANKS NOFARTUS OR SHOULD WE CALL YOU NOIMPREGUS ???

Novartis yanks mispackaged birth-control pills
June 7, 2012 | By Tracy Staton

White placebo pills should be in the Week 13 slot of Sandoz's Introvale--courtesy of the FDA

Contraceptive packaging has become a hazard for drugmaker. Novartis' ($NVS) generic unit Sandoz is recalling 10 lots of a birth-control pill, Introvale, after finding the pills packaged in the wrong sequence.

Introvale is a three-month regimen of 84 active, peach-colored pills taken daily for 12 weeks, followed by 7 inactive pills for the 13th week. A consumer complained that inactive pills were for use in week 9, FDA says, prompting the recall. Taking birth-control pills out of order puts women at risk of pregnancy.

"While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded," FDA said in a statement. If women find a white tablet in any position other than the 13th row, the agency said, they should immediately start using a non-hormonal contraceptive and call their doctors.
 






WOW NOVARTIS THE TAX DODGERS ??????

Novartis in tax fight over vaccine plant that HHS helped pay for

Complex arrangement leads to dispute over 40% share


June 8, 2012 | By Eric Palmer

When the Department of Health and Human Services agreed to pay for 40% of the cost of a new Novartis ($NVS) plant to reserve space for making vaccines in case of a pandemic, it was a pretty good deal for the Swiss company. But the county that houses the plant thinks Novartis is getting too much of a deal.

An appeals court in North Carolina will now decide if the company is entitled to an exemption on real property taxes for the 40% ostensibly owned by the federal government for now, reports the Charlotte/Raleigh CityBizList.

The matter started in 2006, when the town of Holly Springs, NC, gave Novartis land on which to build its vaccine plant. In 2009, HHS offered to pay $316 million, which was 40% of the cost, and to buy up to 96 million flu vaccines a year from Novartis when the plant was operating. Earlier reports pegged the contract amount at $486 million. In exchange, HHS got the right to produce flu vaccine in the plant in case of a flu pandemic, CityBizList reports. For whatever reason, the terms are that HHS owns 40% of the property until it is built and then Novartis gets full ownership.
 






Judge OKs $99 Million Overtime Settlement For More Than 7,000 Novartis Sales Reps

Monday, June 11, 2012

from Human Resources Report

By John Herzfeld

NEW YORK--A federal judge May 31 gave final approval to a $99 million settlement of a nationwide wage and hour class action on overtime claims by more than 7,000 Novartis Pharmaceuticals Corp. sales representatives (In re Novartis Wage & Hour Litig., S.D.N.Y., No. 06-MD-1794, settlement approved 5/31/12).

Judge Paul A. Crotty of U.S. District Court for the Southern District of New York approved the settlement following a fairness hearing held the same day. In January, he granted preliminary approval to the settlement, which stems from a pair of 2006 lawsuits filed under the Fair Labor Standards Act and California and New York laws (30 HRR 91, 1/30/12).

The final order and judgment allocated $70,758,500 to settlement awards for class members; $27,608,000 to attorneys' fees; $400,000 to reimbursement of litigation fees; and $233,500 to class representatives and others involved in the case.

The $233,500 included compensatory damages and service awards ranging from $20,000 to $40,000 for each of five named plaintiffs.
 






DEJA VU .....AGAIN !!!!

THE HINDU
Business » Companies
NEW DELHI, June 15, 2012

Alembic settles patent case with Novartis

Alembic Pharmaceuticals, on Friday, said it, along with Breckenridge Pharmaceutical of the U.S., has settled a patent case with Novartis for Rivastigmine Tartrate capsules used for treating dementia.

The companies have settled their Paragraph IV patent litigation with Novartis for Rivastigmine Tartrate capsules, which are a generic version of Exelon capsules of Novartis, Alembic Pharmaceuticals said in a filing to the BSE.

Under the terms of the settlement agreement, Novartis had granted the two companies a licence to market their generic capsules before the date of the patent expiry, it added. The companies would launch the product immediately in the American market, Alembic Pharmaceuticals said.
 






JIMENEZ GIVES EUROPE'S POOR THE MIDDLE FINGER SWISS SALUTE !

Novartis CEO Says Could Restrict Hospital Credit

Jun. 22, 2012 - Joe Jimenez, chief executive officer of Novartis AG, talks about drug distribution, cash collection and the impact of the European crisis on the pharmaceutical industry. He speaks with Ryan Chilcote on the sidelines of the St. Petersburg International Economic Forum on Bloomberg Television's
 






" NOVARTIS THE ULTIMATE HYPOCRITS IN BRANDED PHARMA !!!"

June 27, 2012, 11:35 a.m. EDT

Novartis battles Ranbaxy over generic Nexium
•By Rumman Ahmed

BANGALORE--Sandoz, the generic pharmaceuticals division of Novartis AG /quotes/zigman/171707/quotes/nls/nvs NVS +1.78% , has filed a citizen petition requesting the U.S. drug regulator revoke the sales exclusivity given to India's Ranbaxy Laboratories Ltd. for a copy of AstraZeneca PLC's /quotes/zigman/134653/quotes/nls/azn AZN +0.81% drug Nexium, a blockbuster treatment for heartburn.

Ranbaxy was the first company to file a generic application for Nexium, making it eligible to get 180 days of sales exclusivity under U.S. federal law.

It received tentative approval from the U.S. Food and Drug Administration for generic Nexium on Feb. 5, 2008, which Sandoz said was a day after the end of the statutory 30-month period counted from the day of filing the generic plea.

Sandoz in the citizen petition dated June 19, said Ranbaxy should forfeit its sales exclusivity as it failed to obtain the approval within the stipulated time frame.

Ranbaxy, a unit of Japan's Daiichi Sankyo Co. Ltd. , had received the FDA's approval for 20 milligram and 40 mg base strengths of esomeprazole magnesium, the generic version of Nexium.

Sandoz's move could jeopardize Ranbaxy's chances of starting exclusive sales of its copy of Nexium from May 27, 2014 on patent expiry in the U.S., thus hurting its chances of making significant profits in the six months before other generic competitors like Sandoz enter the market and push down prices.
 






July 3, 2012 6:28 pm

Novartis’ Gilenya prescriptions slowing, company working on increasing number of monitoring sites
by Kimberly Ha in New York and Abigail Moss in London

Novartis’ (NYSE:NVS) multiple sclerosis (MS) pill Gilenya faces slowing prescriptions in New York because of a lack of facilities to perform first-dose observations, neurologists told Biopharm Insight.

A US Food and Drug Administration (FDA) review was initiated after a patient died within 24 hours of taking the first dose of Gilenya. Regulatory authorities also re-evaluated study data regarding the drug’s effect on heart rate and blood pressure.

Gilenya is now contraindicated for use in patients with certain pre-existing or recent heart conditions or stroke, or those taking certain antiarrhythmic drugs, according to FDA. Extended monitoring is recommended in patients with QT prolongation and in patients who are already taking medication that slows heart rate. Observation includes continuous overnight electrocardiography (ECG) monitoring.
 












VASELLA & JIMENEZ SAY SCREW THE POOR WE NEED A FEW MORE MANSIONS & FRANK GHERY MAYA LIN PALACES TO VISIT

Fears for future of cheaper generic drugs

Updated July 10, 2012 10:43:00

India's generic drug manufacturers, global suppliers of cheap medicines, say a court challenge by the Swiss pharmaceutical giant, Novartis, could cripple their ability to provide drugs to the world's poor. Novartis is challenging Indian law as it fights for a new patent on one of its drugs.

Richard Lindell

TONY EASTLEY: India's supreme court is hearing arguments in a landmark case that could have a big impact on healthcare in the developing world.

India's generic drug manufacturers have become a global supplier of cheap medicines. They're protected by laws that prevent monopoly pricing and frivolous patent applications.

However, Swiss-based Novartis is now challenging the laws as it fights for a new patent on one of its drugs.

Healthcare providers says that a win for Novartis will cripple their ability to provide essential medicines and treatment to the world's poor.

The ABC's Richard Lindell reports from New Delhi.

RICHARD LINDELL: India is known as the pharmacy of the poor and with good reason. Globally it's the third largest producer of drugs by volume and exports generic drugs to the developing world at between 3 and 20 per cent of the cost of brand names.

The pharmaceutical industry has been able to do this because of unique laws that restrict monopoly pricing and evergreening by multinationals.

Pavan Duggal is a supreme court lawyer.

PAVAN DUGGAL: When you look at the statement of objectives of the new amendments to the patents law, the idea of the legislation is very clear - it wants to prevent evergreening, evergreening being a phenomenon where big pharmaceuticals often would seek patents on smaller frivolous changes to known substances so as to further regain and shall I say, were to extend the particular monopolies.

RICHARD LINDELL: But these laws are now being challenged in the supreme court. The Swiss-based firm Novartis is suing the Indian government for denying a patent on an updated version of its 11-year-old anti-cancer drug gleevec.

Novartis India president Ranjit Shahani told French television the new form of the drug is substantially different.

RANJIT SHAHANI: Without patents there will be no Profits in medicines, without that there will be no generics later on in any case. So there's a direct correlation between all of this, but we want are profits.

RICHARD LINDELL: But opponents argue the changes are minor and aim to protect the company's monopoly.

Supreme court lawyer Pavan Duggal says Novartis is asking the court to weaken patent law by accepting a lower threshold for innovations, with implications well beyond gleevec.

PAVAN DUGGAL: There is no two doubts in my mind that the impact of this case is not only going to be landmark but also historic. This case and its principles enunciated by the supreme court will not just impact the anti-cancer drug segment, but it's to impact the complete generic medication pharmaceutical industry in the country.

(Protesters)

RICHARD LINDELL: Medecins Sans Frontieres has been leading a global campaign demanding Novartis drops the case.

Leena Menghaney says MSF relies heavily on generic drugs produced in India and is concerned about the impact of the supreme court case on their ability to treat a range of illnesses.

LEENA MENGHANEY: Generics are going to Latin America, the generics are going to Africa, the generics are going to central Asia, Thailand and of course in India itself.

In HIV, you can count millions of people being affected in itself and we haven't even counted for example tuberculosis or cancer and other diseases. So we are convinced that for HIV treatment this will be a disaster.

For MSF, a few doctors were extremely challenging and came forward to treat AIDS when all we could offer was palliative care. For MSF doctors they do not want to go back to that era.

RICHARD LINDELL: The stakes are just as high for the Indian government and the future of its recently announced billion dollar drugs program for the poor - a policy that depends on generics as a cheap and reliable source of essential medicines.

This is Richard Lindell in New Delhi for AM.
 






Africa: Activists Push Back on Novartis' Attack on the Pharmacy of the Developing World
11 July 2012

Cape Town — Activists from around the world gather in Cape Town and rally against Novartis' attack on the 'pharmacy of the developing world' as the case heads to the Indian Supreme Court.

Health activists, academics, medical doctors, government representatives,and lawyers today held a rally protesting the drug company Novartis' court case against the Indian government, warning that the case could have a devastating impact on access to affordable medicines. The rally was part of a closing march of the 3rd People's Health Assembly, which took place from July 7-July 11 at the University of the Western Cape.

Representatives from Médecins Sans Frontières/Doctors Without Borders (MSF), the Treatment Action Campaign (TAC), Section27, and the People's Health Movement spoke at the rally.

"A win for Novartis will restrict generic access to medicines both within my country and across the world," said Leena Menghaney, manager of MSF's Access Campaign in India. "The threat to the developing world is real - millions of people rely on affordable drugs from India. If patents are granted more easily in India, patients across the world will see their supply of life-saving drugs dry up."

Ever since India refused to grant a patent to Novartis for a cancer drug more than six years ago, the company has been seeking to weaken the core part of India's patent law that formed the basis for the patent being rejected. 'Section 3(d)' of India's Patents Act limits drug patenting in the interest of public health, requiring new drugs to show improved therapeutic efficacy over existing ones in order to deserve a patent. This provision complies with international trade rules and is specifically designed to prevent pharmaceutical companies from abusively extending their patent monopolies for making obvious improvements to existing drugs. The case is meant to have a final hearing at the Indian Supreme Court on August 22.

Should Novartis win, patents would be granted far more broadly in India, blocking the competition among multiple producers that drives prices down.

It would also mean that other big pharmaceutical companies who have pending patent applications on important HIV medicines in India will be easily be able to push for patents on new forms of these medicines, including on their fixed-dose combinations (when the drug is combined with other medicines into a single pill), paediatric versions and formulations that are better suited to warm climates. This will make generic producers vulnerable to expensive lawsuits, which have a chilling effect on generic competition in the long run.

"As a person living with HIV, and reliant on generic medicines, I call on Novartis to drop the case against the Indian government. This may be about profits for them, but it is about life and death for me," said Sydney Makgai of the Treatment Action Campaign. More than 80% of the anti-retrovirals in Africa are sourced from generic producers in India.

"3d has been important in blocking patents on fixed-dose combinations and paediatric versions of drugs in India. Because South African law does not have a version of 3d and allows for new patents on old medicines, FDCs and paediatric versions of medicines, which are crucial to the battle against HIV and TB, can be patented here," said Daygan Eager, Researcher with Section27. "Patients groups and medical organisations look to Indian law as a positive example that other developing countries facing a high burden of disease can follow. If Novartis wins the case, this sets a negative precedent not only in India, but around the world."
 






Excedrin Recall: When Is The Migraine Medicine Coming Back?

Posted: 07/11/2012 11:35 am Updated: 07/11/2012 4:17 pm

It's been half a year since Novartis voluntarily recalled certain packages of Excedrin, NoDoz, Bufferin and Gas-X Prevention over stray or chipped pills, but the popular medicines are not yet back on store shelves.

"When someone finds something that works, and then they're not able to get it, it can be a real problem," Dr. Andrea Synowiec, a neurologist at Allegheny General Hospital, told CBS Pittsburgh

In January of this year, the Food and Drug Administration announced that the recall affects Excedrin and NoDoz medicines with expiration dates of Dec. 20, 2014 or earlier and Bufferin and Gas-X Prevention medicines with expiration dates of Dec. 20, 2013 or earlier.

The FDA explains why the recalled medicines have the potential to be dangerous:

Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient.
 






How about laying off 2,000 people in EH and the Field this year and telling the people that are left that it is all part of a master plan called "WINNING IN THE US"! Brilliant.
 






Anonymous said:
How about laying off 2,000 people in EH and the Field this year and telling the people that are left that it is all part of a master plan called "WINNING IN THE US"! Brilliant.
Click to expand...

You know how the euro trash leaders are,
big into cheese american pop culture.
They really meant SINGING "Party in the USA"
(Miley is still cool to them)
 






Here's How Novartis Is Making You So Much Cash
By Seth Jayson, The Motley Fool

Posted 10:12AM 07/24/12 Posted under: Investing


All cash is not equal
Unfortunately, the cash flow statement isn't immune from nonsense, either. That's why it pays to take a close look at the components of cash flow from operations, to make sure that the cash flows are of high quality. What does that mean? To me, it means they need to be real and replicable in the upcoming quarters, rather than being offset by continual cash outflows that don't appear on the income statement (such as major capital expenditures).

For instance, cash flow based on cash net income and adjustments for non-cash income-statement expenses (like depreciation) is generally favorable. An increase in cash flow based on stiffing your suppliers (by increasing accounts payable for the short term) or shortchanging Uncle Sam on taxes will come back to bite investors later. The same goes for decreasing accounts receivable; this is good to see, but it's ordinary in recessionary times, and you can only increase collections so much. Finally, adding stock-based compensation expense back to cash flows is questionable when a company hands out a lot of equity to employees and uses cash in later periods to buy back those shares.

So how does the cash flow at Novartis look? Take a peek at the chart below, which flags questionable cash flow sources with a red bar.



Source: S&P Capital IQ. Data is current as of last fully reported fiscal quarter. Dollar values in millions. TTM = trailing 12 months.

When I say "questionable cash flow sources," I mean items such as changes in taxes payable, tax benefits from stock options, and asset sales, among others. That's not to say that companies booking these as sources of cash flow are weak, or are engaging in any sort of wrongdoing, or that everything that comes up questionable in my graph is automatically bad news. But whenever a company is getting more than, say, 10% of its cash from operations from these dubious sources, investors ought to make sure to refer to the filings and dig in.

With 16.5% of operating cash flow coming from questionable sources, Novartis investors should take a closer look at the underlying numbers. Within the questionable cash flow figure plotted in the TTM period above, other operating activities (which can include deferred income taxes, pension charges, and other one-off items) provided the biggest boost, at 10.4% of cash flow from operations. Overall, the biggest drag on FCF came from capital expenditures, which consumed 16.0% of cash from operations.

A Foolish final thought
Most investors don't keep tabs on their companies' cash flow. I think that's a mistake. If you take the time to read past the headlines and crack a filing now and then, you're in a much better position to spot potential trouble early.
 






Bristol-Myers Sues Novartis to Block Proposed Generic Baraclude


Published July 26, 2012

Dow Jones Newswires

Bristol-Myers Squibb Co. (BMY) has filed a lawsuit seeking to block a Novartis AG (NVS) unit from selling a generic version of hepatitis B drug Baraclude before its U.S. patent expires.

Bristol-Myers filed the patent-infringement lawsuit against Novartis's Sandoz unit in U.S. District Court in Delaware in June, Bristol-Myers disclosed in a quarterly report filed with the Securities and Exchange Commission Wednesday.

New York-based Bristol-Myers said its U.S. patent for Baraclude expires in 2015. Baraclude, which was introduced in the U.S. in 2005, generated $682 million in global sales for the first half of 2012, up 20% from the year-earlier period. U.S. sales were $114 million.

Sandoz notified Bristol-Myers in May that it had applied for U.S. Food and Drug Administration approval to market a generic version of Baraclude prior to the expiration of the patent. Sandoz challenged the validity of certain claims in the patent and said it was unenforceable.

Bristol-Myers said in its lawsuit that Sandoz's proposed generic Baraclude product would infringe upon its patent, which was issued in 1993. The lawsuit seeks a court order barring sale of generic Baraclude until the patent expires in 2015.

A Novartis spokeswoman declined to comment.

Bristol-Myers previously filed a similar lawsuit in 2010 against Teva Pharmaceutical Industries Ltd. (TEVA) to block Teva's bid to sell generic Baraclude. That triggered a 30-month delay in any FDA approval of Teva's application, under federal law governing drug patent challenges.
 






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