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A.M. Vitals: Ranbaxy Launches Generic Lipitor in U.S.

Generic Lipitor Approval: Indian drug company Ranbaxy, a unit of Japan’s Daiichi Sankyo, has received FDA approval for its generic version of Pfizer’s Lipitor, the WSJ reports. (Ranbaxy will share profits from the drug during the first 180 days with Teva, according to the company.) The FDA says Ranbaxy’s atorvastatin calcium tablets will be manufactured by Ohm Laboratories in New Jersey. Meantime, Watson Pharmaceuticals yesterday began selling a version of generic Lipitor authorized by, and in partnership with, Pfizer.
Counseling About Weight Loss: Medicare’s decision to cover screening and counseling for weight loss is being hailed as positive news for obese Americans, but experts are also warning that physicians and other health-care providers lack training and time to help patients with weight loss, USA Today reports. One physician tells the paper he thinks weight-loss counseling could be delivered via the telephone and Internet to save money, and hopes Medicare will consider reimbursing for that option.
Quorn Controversy: The Center for Science in the Public Interest is warning consumers about the rare possibility of severe allergic reactions to Quorn, a meat substitute made from a fermented fungus mixed with other ingredients, and has asked the FDA to remove the product from the market, the WSJ reports. CSPI cites 500 complaints about the food that it’s received in the U.S. over the last decade; the FDA says it’s received only seven over seven years and that it hasn’t been able to confirm that life-threatening allergic reactions were involved. The manufacturer says that “one [person] in between 100,000 and 200,000 may have a sensitivity” to Quorn.
NYC Recommendations for HIV Patients: New York City Health Commissioner Thomas Farley says people infected with HIV should be offered antiretroviral drugs at the time of diagnosis rather than waiting until the virus takes its toll on the immune system, the Associated Press reports. Experts told the AP the science backs up Farley’s recommendation, but that the high cost of the drugs remains a potential obstacle. Other issues include side effects of the drugs and the worry that patients who start the medications but don’t take them consistently can develop resistance, the AP says.

Source : http://blogs.wsj.com/health/2011/12/01/a-m-vitals-ranbaxy-launches-generic-lipitor-in-u-s/

What Are the Side Effects of LIPITOR?

Common Lipitor Side Effects:
 The most common Generic Lipitor side effect is myalgia, which tends to present itself as muscle pain and weakness, varying from mild to severe. In its most severe form this can be what is called rhabdomyolysis, a condition where muscle cells are broken down releasing large amounts of degraded proteins into the blood stream. Protein degradation can lead to acute renal injury and failure.

This severe form is very uncommon, even rare, but mild to moderate myalgia is common. Other common Lipitor side effects include arthritis/arthralgias, diarrhea, headache, rashes, elevation of liver transaminases, elevation of creatine kinase (a muscle enzyme), various gastrointestinal symptoms including flatulence, dyspepsia, and abdominal pain, and various infection symptoms.

What is Generic Lipitor ?

Generic Lipitor is simply cheaper versions of brand Lipitor, the most active ingredients that make it suitable for consumption. Gone are the days of fear. As we all know the Generic Lipitor is cholesterol lowering drug, which was introduced as a cheaper alternative and the mark was Lipitor.

Lipitor for lowering cholesterol and triglycerides suitable for certain patients. It also increases high-density lipoprotein (HDL, "good cholesterol"). It is along with a proper diet. It is also used in certain patients to reduce the risk of heart attack, stroke, blood vessels, or chest pain of angina pectoris. It can be used to treat other diseases can be determined by your doctor.

Pfizer Maneuvers to Protect Lipitor from Generics

New York-based Pfizer has devised discounts and incentives for patients, insurers and companies that process prescriptions that will, at least for the next six months, make the brand name drug about as cheap as or cheaper than the generics. Pfizer also has spent tens of millions of dollars this year on marketing to keep patients on Lipitor, which loses patent protection Wednesday.
Normally when a drug's patent ends, generic rivals grab nearly all its market share in a year or less, and the original maker quietly shifts focus to its newer products.
Pfizer (PFE) , the world's biggest drugmaker, is not giving up that easy on the best-selling drug in history. Lipitor had peak sales of about $13 billion and still brings in nearly $11 billion a year, about a sixth of Pfizer's revenue. With no new blockbusters to fill that hole, the company is making an unprecedented push to hang onto Lipitor revenue as long as possible.
Pfizer's strategy is cunning and could become the new norm in the pharmaceutical industry, as most other drugmakers also face generic competition to top-selling medicines and haven't been able to come up with profitable replacements.
"People getting a month of lifesaving medicine for the price of a cup of Starbucks is … pretty impressive," said Michael Kleinrock, a research director at data firm IMS Health.
Pfizer's effort includes:
—Offering insured patients a discount card to get Lipitor for $4 a month, far below the $25 average copayment for a preferred brand-name drug and below the $10 average copay for a generic drug. Pfizer is promoting this heavily through ads, information distributed at doctors' offices and its www.LipitorForYou.com site. Pfizer said Tuesday that sign-ups have exceeded its goals.
—Paying pharmacies to mail Lipitor patients offers for the $4 copay card and to counsel patients that Lipitor lowers bad cholesterol more than rival drugs and helps prevent heart attacks and strokes.
—Keeping U.S. marketing spending nearly level until the last minute, vs. the typical two-thirds drop in a drug's final year under patent. From July through September, Pfizer spent almost $90 million on doctor sales calls and free samples, about the same as a year earlier, according to Cegedim Strategic Data. Ads targeting patients fell about 60% to $19 million. All that will soon taper off.
— Negotiating unusual deals with some insurance plans and prescription benefit managers, the companies that process prescription claims for insurers or employers, to block pharmacists from dispensing generic Lipitor. Pfizer is giving them rebates that bring their cost for Lipitor down to the price of a generic or slightly less — if they agree to dispense only Lipitor for the six months before additional generic competition slashes prices. The move has generated some controversy and means many of the 3 million Americans taking Lipitor won't be able switch to the generic.
Under those contracts, patients will pay either their plan's standard generic copayment or just $4 — the lowest copayment pharmacies at supermarkets and discounters, such as Wal-Mart, offer for the most widely used generic drugs.
For now, patients seem to be buying into the logic.
"If I can get the name brand at the same price or for pennies more than the generic, I have no motivation to switch," said Richard Shiekman, 59, who has been taking Lipitor for six years and credits the drug with sharply cutting his bad cholesterol. Shiekman, a wine and spirits importer from Redding, Conn., got a $4 copay card two weeks ago after his pharmacy sent an offer guaranteeing that price through December 2012.
While generic medicines work the same as brand drugs for nearly everyone, some patients prefer the brand.
"We want to make sure that patients who are currently taking Lipitor and want to continue … have the opportunity to do so," said David Simmons, who heads Pfizer's Established Products business. He said research shows more than a third of patients want to stay on Lipitor.
Pfizer also is continuing assistance programs that subsidize uninsured patients wanting Lipitor, which costs about $115 to $160 a month, depending on dosage. Generic Lipitor, called atorvastatin, should cost 30% to 50% less.
People without insurance also can order the generic, with a prescription, through websites such as www.HealthWarehouse.com.
Patients could save even more by taking other generic drugs in the same class that have been on sale for several years: pravastatin (Pravachol) and simvastatin (Zocor). But they're not as potent as Lipitor, the key reason its sales have held up.
Typically, brand-name drugs get one or two generic competitors initially, priced about 25% lower. Six months later, other generic companies are allowed to jump in and the price drops as much as 80%.
About 90% of the branded drug's sales ultimately vanish, as insured patients seeking a lower copayment switch over and most pharmacies automatically substitute a generic for a brand name.
Sanford Bernstein analyst Dr. Tim Anderson estimates that for a 90-day supply of Lipitor, even after paying rebates to insurers and patients, Pfizer can make a profit of roughly $100, compared with about $225 before generic competition. That's partly because administrative and advertising costs will decline, and it barely costs a dime to make a pill.
Anderson expects Pfizer's strategy to boost its earnings per share about 2% next year. The stock traded as high as $21 a share during the summer but has since dropped back to just under $20 a share.
Meanwhile, Parsippany, N.J.-based Watson Pharmaceuticals (WPI) looks to be the biggest loser in this. It has a deal to distribute an "authorized generic" version manufactured by Pfizer but sold under Watson's brand, with Pfizer keeping an estimated 70% of the price.
Watson CEO Paul Bisaro said he had thought Pfizer would retain about 25% of Lipitor users for the next six months, but now "it looks like it will be 40% to 45%."
Bisaro said that could reduce his company's anticipated profit next year.
"This is sort of the new generation of brand protection," he added.
India's Ranbaxy Laboratories (RBXD) is the only company besides Watson with the right to sell generic Lipitor the U.S. for the next six months. But Ranbaxy has had repeated manufacturing quality problems, and it's unclear whether it will have the Food and Drug Administration's approval to ship its version come Nov. 30.
Ranbaxy said it would not reveal what will happen until then. The FDA, as is its custom, declined to comment. But Pfizer executives say they expect Ranbaxy to have a generic on the market.
An independent pharmacists' group called Pharmacists United for Truth and Transparency has raised alarms that the rebate deals will stick plan sponsors — employers, unions and taxpayers — with higher costs than for generics.
But spokespeople for a few prescription benefit managers that have received Pfizer's offer say it would cost insurance plans and patients the same as, or slightly less than, for generic Lipitor.
"Next year we're going to save clients and members over $1 billion just on this drug," said Tim Wentworth, head of employer and key client accounts for Medco Health Solutions (MHS), one of the biggest pharmacy benefits managers.

Source: http://www.usatoday.com/money/industries/health/treatments/story/2011-11-29/Pfizer-maneuvers-to-protect-Lipitor-from-generics/51475288/1