Generic Version

Wanda Ferrin fills her husband's prescription for the generic antibiotic doxycycline at a Target in Simi Valley. For years, the medication has cost her $6 a month. In February, however, the price tripled to $18 for 30 pills. And this month, it skyrocketed to $133. This is noteworthy enough. But what happened next makes the entire business of drug pricing a study in lunacy. "A pharmacy clerk at Target suggested running the prescription through the company's discount program," Ferrin, 61, recalled.

Federal regulators said Friday they would continue to allow sales of generic Opana, a narcotic painkiller similar to OxyContin, even though the pills are prone to abuse. Like OxyContin, Opana is an extended-release narcotic designed to offer pain relief over several hours. Crushed extended-release pills are popular among addicts who snort the powder or liquefy and inject it, releasing the full dose at once. In response to growing criticism of its widely abused OxyContin, Purdue Pharma introduced a tamper-resistant formulation in 2010.

In a closely watched decision, the Food and Drug Administration on Friday approved an application by German drug maker Sandoz and Momenta Pharmaceuticals Inc. of Cambridge, Mass., to make the first generic version of the widely used blood thinner Lovenox. The approval positions Momenta and Sandoz to offer a cheaper but still lucrative alternative to Lovenox, which had sales of $4.5 billion in 2009, making it the 15th-bestselling drug in the world. In its decision, the FDA also rejected an argument by Lovenox's maker, Sanofi-Aventis, that its drug, which is made from sugar molecules found in heparin, a substance derived from pig intestines, is too complex to be copied with precision by makers of generic versions of the medication.

Wanda Ferrin fills her husband's prescription for the generic antibiotic doxycycline at a Target in Simi Valley. For years, the medication has cost her $6 a month. In February, however, the price tripled to $18 for 30 pills. And this month, it skyrocketed to $133. This is noteworthy enough. But what happened next makes the entire business of drug pricing a study in lunacy. "A pharmacy clerk at Target suggested running the prescription through the company's discount program," Ferrin, 61, recalled.

The first generic versions of Zoloft received federal approval. Israel's Teva Pharmaceutical Industries Ltd. said it would make generic versions of the antidepressant in 25-, 50- and 100-milligram tablets. Roxane Laboratories Inc., based in Columbus, Ohio, would make a liquid concentrate version of the drug, the Food and Drug Administration said. Pfizer Inc.'s patent on Zoloft expires today.

A federal judge cleared the way for Ivax Corp. to sell a generic version of Bristol-Myers Squibb Co.'s breast cancer drug Taxol. U.S. District Judge Colleen Kollar-Kotelly in Washington rejected a request by Santa Monica-based American BioScience Inc. that was aimed at blocking the generic version.

Eli Lilly & Co. could face generic competition on its blockbuster antidepressant drug Prozac as early as next month. Lilly had hoped to extend its patent on the drug through 2003, but the federal appeals court in Washington, D.C., would not reconsider a ruling that the drug company's 2003 patent is invalid. Lilly plans to appeal to the Supreme Court. "For business planning purposes we continue to operate under the assumption that fluoxetine [Prozac] will enter the generic market on Aug.

Generic-drug makers including Ivax Corp. and Teva Pharmaceutical Industries Ltd. aren't infringing patents on Pfizer Inc.'s epilepsy drug Neurontin by selling low-cost versions, a federal judge ruled. U.S. District Judge John Lifland in Newark, N.J., said the generic version of gabapentin, the key ingredient in Neurontin, didn't infringe. Pfizer will appeal, spokesman Paul Fitzhenry said. Teva, Ivax and Alpharma Inc.

A Canadian company's generic version of the blood thinner Plavix has been blocked from the U.S. market until at least 2011. U.S. District Judge Sidney H. Stein said Tuesday that Apotex Inc. had failed to prove during a three-week trial in New York this year that the patent protecting Plavix from competitors was invalid. Apotex said it would file an immediate appeal with the U.S. Court of Appeals for the Federal Circuit in Washington.

Bristol-Myers Squibb Co. and Sanofi-Aventis on Thursday won a bid to stop Apotex Inc. from selling its cheaper generic version of the Plavix heart pill, the world's second-biggest-selling medicine. Bristol-Myers shares surged. U.S. District Court Judge Sidney H. Stein in New York ruled that Bristol-Myers and Sanofi were likely to win their patent-infringement suit against Apotex and wouldn't be able to recoup losses if generic sales were allowed to continue.

Drug maker Ranbaxy Laboratories Inc. has recalled some of its generic version of Lipitor in the U.S. after finding small glass particles in some batches. The Indian company's recall of atorvastatin calcium, a generic form of Pfizer Inc.'s top-selling Lipitor, may temporarily disrupt supplies in the U.S. while the company conducts an investigation into these problems with the drug. Ranbaxy said the recall involves 10, 20 and 40-milligram dosage strength in 90 and 500-count bottles.

The Food and Drug Administration took a highly unusual step this week: It acknowledged that a widely used generic drug -- a copycat of the antidepressant Wellbutrin XL -- was not the equivalent of the original drug produced by GlaxoSmithKline since 2003. The move prompted the world's largest manufacturer of generic drugs, Israel-based Teva Pharmaceuticals, to stop shipping its generic extended-release bupropion -- marketed as Budeprion 300 mg XL-- and to remove it from U.S. shelves.

Thanks for assisting your readers now negotiating the array of issues surrounding Lipitor (atorvastatin) and the expiration of its patent ["The New Deal With Lipitor," Jan. 16]. When a drug has generated $81 billion, the manufacturer will do all it can to preserve a portion of that income stream. They cite the drug's fine track record and play on the status of the brand. Patients should consider that neither track records nor status can lower cholesterol. It will take at least six months for this drug to be fully available with generic pricing.

Lipitor, the top-selling drug that lowers LDL cholesterol (the bad kind) will cease being Pfizer's cash cow as of Wednesday. The brand-name drug will still be available, but now patients can ask for the less-expensive generic version, called atorvastin. Lipitor generated more than $100 billion in revenue for Pfizer since it was approved in 1997. Patients need not fear that generic atorvastatin will be an inferior medication. According a 2010 study in the journal Clinical Therapeutics , patients receiving Lipitor in an eight-week study had a 48% reduction in LDL cholesterol compared to a 44% reduction among people taking the generic.

Generic drugs have long held an unusual place in the world of medicine. They have the same ingredients, the same power to treat and the same potential to harm as brand-name prescription drugs. But they’re sold under different names at bargain-rate prices. They’re often manufactured overseas , making them visitors that live under their own set of rules. Now the U.S. Supreme Court has given these drugs a sort of diplomatic immunity. In a 5-4 split -- with the conservative wing on the winning side -- the court ruled that patients can’t sue makers of generic drugs for complications or side effects not listed on labels.

In 2001, Abbott Laboratories spent nearly $7 billion on the biggest acquisition in the company's 123-year history, primarily to get access to one drug: Humira. Since then, the North Chicago drug giant has raked in more than $24 billion in sales from Humira, a pricey medicine derived from human cells and used to treat a variety of autoimmune diseases. This year, Humira is forecast to have its biggest year ever, with some analysts projecting more than $7 billion in sales. But the national healthcare law is intended to put the brakes on the profit bonanza from Humira, as well as many other biotechnology drugs, by opening up the sector to generic competition.

At least three generic versions of the popular osteoporosis treatment Fosamax are headed for pharmacy shelves with the expiration of the drug's main patent Wednesday, bringing patients hefty savings. Two of the biggest makers of generic drugs, Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals Inc., said Wednesday they would immediately begin selling generic Fosamax, which is made by Merck & Co.

A federal judge in Delaware ruled Friday for Pfizer Inc. and against Ranbaxy Laboratories Ltd. in a patent fight over rights to the blockbuster cholesterol-lowering drug Lipitor. U.S. District Judge Joseph Farnan Jr. said Ranbaxy's generic version of the cholesterol treatment infringed two Pfizer patents. He also found the New Delhi-based generic drug maker failed to prove Pfizer's patents were invalid or unenforceable.

In a closely watched decision, the Food and Drug Administration on Friday approved an application by German drug maker Sandoz and Momenta Pharmaceuticals Inc. of Cambridge, Mass., to make the first generic version of the widely used blood thinner Lovenox. The approval positions Momenta and Sandoz to offer a cheaper but still lucrative alternative to Lovenox, which had sales of $4.5 billion in 2009, making it the 15th-bestselling drug in the world. In its decision, the FDA also rejected an argument by Lovenox's maker, Sanofi-Aventis, that its drug, which is made from sugar molecules found in heparin, a substance derived from pig intestines, is too complex to be copied with precision by makers of generic versions of the medication.

A new appeal in a conflict-of-interest controversy involving the Food and Drug Administration's handling of the deadly heparin contamination crisis of 2008 has shed more light on the convoluted and costly maneuvering that can break out when billions of dollars in profits are at stake. The latest round began last week when Amphastar Pharmaceuticals Inc. of Rancho Cucamonga said it would appeal the FDA's rejection of a complaint. The privately held drug maker alleged that Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, had a conflict of interest.