Entries in Generic Prescriptions (7)


Glass Particles Found in Generic Version of Lipitor

Brand X Pictures/Thinkstock(WASHINGTON) -- The pharmaceutical company that makes the generic version of the cholesterol-lowering drug Lipitor, also known as atorvastain, has shut down production while it tries to figure out how tiny glass particles got into the pills, the Food and Drug Administration announced on Thursday.

The federal agency said it had not received any reports of patients being harmed by the glass particles found in pills manufactured by Ranbaxy Pharmaceuticals.

Earlier this month, the company, which is the largest producer of the generic version of Lipitor, recalled more than 40 lots of the drug because of the glass contamination.

The company has not said where the generic drug was manufactured or how the problem occurred, but a spokesperson for the FDA said Ranbaxy has agreed to stop making the pill’s active ingredient until an investigation is complete.  The active ingredient is made in India.

The incident is the latest episode in a recent history of manufacturing lapses at the company.  Earlier this year, Ranbaxy was barred from importing 30 drugs after federal authorities discovered the company had numerous record-keeping violations and manufacturing problems at overseas facilities.

Dr. Edward Boyer at the University of Massachusetts Medical School said the contamination is not necessarily a threat to a person’s health, but it is a cause for concern.

He says eating a pill that has particles of glass a millimeter in size or less is akin to swallowing a pill containing small bits of sand.  Still, Dr. Boyer said if a patient on the medicine came to him, he would recommend they replace it with a known, safe alternative.

Copyright 2012 ABC News Radio


Report: Generic Drugs Saved Healthcare $1 Trillion

Medicine iStockphoto/Thinkstock(WASHINGTON) -- The U.S. healthcare system has saved more than $1 trillion over the last decade, new research released by the Generic Pharmaceutical Association (GPhA) showed Thursday.

An analysis of government data by researchers at IMS Health found that the healthcare system's use of generics had generated $1.02 trillion in savings from 2002 to 2011, and that number is growing.  The Generic Drug Savings Analysis revealed that just in 2011, the healthcare system had save $192 billion -- that's more than $1 billion in savings every other day, the report notes.

Here are other key observations by IMS, according to the analysis:

  • Savings from generic use in 2011 increased 22 percent over the prior year, marking the largest year-over-year increase since 1998, and 10 percentage points higher than the 10-year average increase.
  • Newer generic medicines -- those that have entered the market since 2002 -- continue to provide an increasingly higher share of the savings, totaling $481 billion over the past decade.
  • The greatest one-year savings growth rate came from cancer treatments, which produced $10 billion in savings in 2011, more than three times higher than the $3 billion saved in 2010.
  • Nearly 80 percent of the 4 billion prescriptions written in the U.S. in 2011 were dispensed using safe and effective generic versions of their brand name counterpart drugs.

With the release Thursday of this new data, the GPhA hopes to see increased use of generics to help "Congress and the White House gear up for the fiscal challenges facing them in the coming year," said Ralph G. Neas, GPhA President and CEO.

"The remarkable findings demonstrated in this report are a testament no only to the generic industry's tremendous accomplishments over the past decade, but to the even greater achievements that are still to come," Neas said.

"The sustainability of the health care system and the national economy depend in significant measure on the availability of affordable medicines."

Copyright 2012 ABC News Radio


Senators Pan Pfizer’s Plan to Block Generic Lipitor

PRNewsFoto/Amgen(WASHINGTON) -- Pfizer’s plan to persuade health insurance and benefits companies to favor Lipitor over its new generic competition has three Senators crying foul.

The patent on Lipitor, the cholesterol-lowering statin that earned Pfizer more than $5.3 billion in annual U.S. sales, has now expired, opening the door for cheaper generic versions.  But Pfizer is offering large discounts to pharmacy benefit managers -- the middlemen between drug companies and health insurance providers -- that block the competition.

“Consumers and taxpayers foot the bill when drug benefit companies and insurers manipulate the marketplace to prevent access to generic drugs for millions of Americans,” Sen. Herb Kohl, D-Wis., said in a statement.  “We hope that scrutiny into these business practices will restore fairness and open the gates to affordable prescription drug choices and tremendous cost savings.”

Kohl joined Sens. Max Baucus, D-Mont., and Charles E. Grassley, R-Iowa, in asking Pfizer, three pharmacy benefit companies and two insurance companies for more information about the agreements, citing concerns about the impact on health care costs.

“By working with manufacturers to push brand-name drugs, drug benefit companies may be abusing Medicare to boost their profits and denying generic alternatives to patients -- a practice that needs to end immediately,” Baucus said in a statement.  “We need to take a close look to ensure we’re protecting both taxpayer dollars and access to the medicine patients need.”

Under Pfizer’s plan, which was first reported by The New York Times, the co-pay for a 30-day supply of Lipitor would drop to $10 -- the same co-pay as generic versions.  The Senators worry pharmacy benefit managers will continue charging employers and Medicare the full cost of the drug and pocket the difference.  In letters to the companies, they’re asking for clarification.

On Wednesday, the U.S. Food and Drug Administration approved the first generic version of Lipitor, made by Ranbaxy Laboratories Ltd.  Ranbaxy has exclusive rights to sell the generic for 180 days, during which time it will be Lipitor’s sole competitor.

In an email to ABC News, Pfizer spokesman MacKay Jimeson said the Senators’ letter is based on “incomplete and incorrect information.”

“Our intent is to offer Lipitor to payers and patients at or below the cost of a generic during the 180-day period.  As a result, patients receive Lipitor at co-pays comparable to generics,” he wrote.  “Participation in Pfizer’s programs by a health plan is entirely voluntary.  It is not imposed on any plan either by Pfizer or their [pharmacy benefit manager].”

The Senators asked the companies to respond to their letters no later than Dec. 21.

Copyright 2011 ABC News Radio


Consumers Will Pay Half as Much for Generic Version of Lipitor

Brand X Pictures/Thinkstock(NEW YORK) -- Angus Hepburn, of Beacon, N.Y., has been taking Lipitor, a cholesterol-lowering drug, since 2009, after he had a heart attack. He credits the drug with helping him bring his cholesterol level down to a healthy level.

Lifesaving as Lipitor may be, it's expensive. Hepburn, who has an employer-based health plan with pharmacy benefits manager MedCo Health Solutions, said he pays about $200 every three months in co-payments and deductibles to take the brand-name drug.

But Hepburn and the 8.7 million Americans who take Lipitor, which is in a class of drugs called statins, for their high cholesterol are in for a pleasant change. On Wednesday, the drug's patent expires, opening the market for cheaper, generic versions of Lipitor, which should lower costs for consumers by about 50 percent.

Lipitor has been a moneymaker for its manufacturer, Pfizer. In 2010 alone, the drug earned the company more than $5.3 billion in U.S. sales. Many patients have been eagerly awaiting the patent's expiration and the money it will save them on their prescriptions.

Dr. Nieca Goldberg, medical director of the New York University Women's Heart Program, said many of her patients have asked about the release of a generic Lipitor.

Hepburn said Lipitor's going generic is the best news he's heard in a while.

"If I want to stay alive, I've got to keep taking these things," he said. "You've just got to bite the bullet and pay the charges until something like this happens."

For patients currently taking Lipitor, here are answers to the questions that will inevitably arise when the Lipitor patent expires and the drug goes generic:

Will the generic version be the same as Lipitor? Although the new pill may look different and will cost less, doctors say the generic version of the drug, called atorvastatin calcium, will be basically the same as the brand version. To receive approval from the U.S. Food and Drug Administration, generic drugs must contain the same active ingredients as their original patented counterparts.

What will happen when I need to refill my Lipitor prescription? Consumers can still get a Lipitor prescription filled at their pharmacies once the drug's patent expires. But whether they get the brand-name drug or the generic will depend on what kind of health insurance plan they have. Some plans automatically require consumers to get less-expensive generic drugs, if they exist, while other plans leave it to consumers to decide if they want to pay higher co-payments for the brand-name drugs.

Another question remains about whether initial supplies of atorvastatin will be sufficient to meet demand from consumers who want to switch to the generic right away. Ranbaxy Laboratories, the manufacturer with exclusive rights to sell atorvastatin for the first 180 days of the patent expiration, did not respond to requests for comment about its initial supply of the drug.

Experts say patients should check with their pharmacists about whether atorvastatin is available and covered by their health plans. They should also check with their doctors to learn if their prescriptions specify that they take Lipitor, and ask if a switch to the generic is possible.

How much money will I save by switching? Most experts say consumers can expect to pay about 50 percent less for atrovastatin as they did for Lipitor. Co-payments for Lipitor range from $25 to about $50, depending on a patient's health plan. Co-payments for the generic form of the drug will drop to $10.

After the next 180 days, Ranbaxy's exclusive rights to sell the generic drug will expire, opening the door to even more manufacturers, which could drive prices down even further. But many experts say consumers will see the biggest price differences as soon as the drug goes generic on Wednesday.

What if I want to keep taking Lipitor? Some health plans allow patients to choose to stay on Lipitor and pay the difference between the brand and generic cost. Consumers should check on the policies of their health plans and their state regarding mandatory prescriptions of generic drugs.

Patients can get Lipitor directly from Pfizer. The company has set up a discount program called Lipitor for You, which will allow participants to sign up and receive a discount card to get Lipitor for $4 a month. Pfizer has negotiated with health plans to make the drug available at or lower than the rate of generic drugs for the next 180 days.

Copyright 2011 ABC News Radio


Generic Drug Makers May Soon Pay for Inspection of Overseas Plants

Ryan McVay/Photodisc/Thinkstock(WASHINGTON) -- One of the world's largest generic drug makers is calling on its fellow manufacturers to help foot the bill for the U.S. Food and Drug Administration (FDA) to conduct inspections of overseas pharmaceutical plants.

Up to 40 percent of the drugs Americans use are imported, and around 80 percent of the active ingredients in those drugs are made in foreign facilities. The FDA only inspected 11 percent of the more than 3,700 foreign manufacturing sites in 2009, according to data from the U.S. Government Accountability Office (GAO). All manufacturing facilities in the United States, however, are subject to FDA inspection every two years.

In addition, the GAO determined the FDA does not have accurate information on all of the overseas facilities, meaning the agency could not keep track of where inspections were needed.

One infamous result of such oversight problems occurred in 2008, when Chinese manufacturers substituted a fake ingredient for the main one in a supply of the blood thinner heparin.  The contaminated drug killed 81 people in the United States and sickened hundreds of others.  The FDA never inspected the plants that manufactured the main ingredient.

Hoping to prevent similar situations from happening again, Mylan Pharmaceuticals is helping to negotiate an agreement between the FDA and generic drug makers that would provide $299 million a year for inspections.  That sum would come from fees paid by the manufacturers themselves.

The plan, which was first reported by The New York Times, was the brainchild of Mylan's president, Heather Bresch, who discovered that Mylan's foreign plants weren't held to the same quality and safety standards as the company's U.S.-based facilities.

"Every American has the right to know that whenever they go to have a prescription filled, it's held to the same standard of quality, whether it's made in the U.S. or overseas," Bresch told ABC News.

Bresch worked hard to win support for the plan from other generic drug makers.

"Generics account for 75 percent of prescription drug volume, and our industry was willing to step up," she said. "It's our chance to address issues of safety and standards."

Copyright 2011 ABC News Radio


Ten Top-Selling Drugs Coming Off Patent

Jupiterimages/Thinkstock(NEW YORK) -- Ten of the world's top-selling prescription drugs are about to get cheaper.

Over the next 17 months, the patents on brand-name medications like the cholesterol-lowering drug Lipitor and the blood thinner Plavix will expire, opening the door for generic versions that could cost up to 80 percent less. Name-brand drug costs could also fall because of the new competition. It might be bad news for drug makers, but good news for patients.

Here's a look at the 10 blockbuster drugs coming off patent:

1. Plavix

When a clot builds up or lodges in a blood vessel, it restricts blood flow and could cause a heart attack or stroke. Plavix, which belongs to a class of drugs called blood thinners or anti-platelets, can help keep blood flowing smoothly -- for about $162 per month. In 2010, Plavix earned co-marketers Bristol-Myers Squibb and Sanofi-Aventis more than $6.1 billion in U.S. sales. A generic version could be available in the U.S. in May 2012.

2. Lipitor

High blood levels of cholesterol can lead to a build-up of fat on the inside of blood vessels, narrowing the opening through which the blood can flow and increasing the risk of heart attack and stroke. Lipitor, which belongs to a class of drugs called statins, can decrease the amount of cholesterol in the blood and lower heart attack and stroke risk. It can cost up to $168 per month. In 2010, Lipitor earned Pfizer more than $5.3 billion in U.S. sales. A generic version could be available in the U.S. in November 2011.

3. Seroquel

Seroquel is used to treat the symptoms of schizophrenia and bipolar disorder. It belongs to a class of drugs called atypical antipsychotics, which work by changing the activity of certain chemicals in the brain. Depending on the dose, the drug costs about $549 per month. In 2010, Seroquel earned AstraZeneca more than $3.7 billion in U.S. sales. A generic version could be available in the U.S. in the spring of 2012.

4. Actos

Actos is used to treat type 2 diabetes -- a chronic disease that's on the rise nationwide. The drug belongs to a class of medications called thiazolidinediones and can increase the body's sensitivity to insulin and help control blood sugar levels. It costs up to $241 per month. In 2010, Actos earned Japanese manufacturer Takeda more than $3.3 billion in U.S. sales. A generic version could be available in the U.S. in August 2012.

5. Enbrel

Enbrel is used to treat the autoimmune diseases rheumatoid arthritis and psoriasis. The drug, which belongs to a class of medications called tumor necrosis factor (TNF)-alpha inhibitors, acts as a decoy receptor in the body and soaks chemicals that propagate the autoimmune reaction. It costs up to $2,784 per month. In 2010, Enbrel earned Amgen more than $3.3 billion in U.S. sales. The patent expires in August 2012. But because the drug is a "biologic" that mimics the body's own receptor, it's subject to different laws and companies can't manufacture a generic version in the U.S.

6. Singulair

Singulair is used to prevent symptoms of asthma and allergies. In 2010, Singulair earned Merck over $3.2 billion in U.S. sales. A generic version could be available in the U.S. in August 2012.

7. Levaquin

Levaquin is an injectable antibiotic used to treat pneumonia as well as infections of the sinus, urinary tract, kidney and skin. A generic version of the drug, which belongs to a class of bacteria-killing medications called fluoroquinolones, is available in tablet form. But the injectable form is still under patent. In 2010, Levaquin earned over Johnson & Johnson $1.3 billion in U.S. sales.

8. Zyprexa

Zyprexa, like Seroquel, is an atypical antipsychotic used to treat the symptoms of schizophrenia and bipolar disorder. It costs up to $641 per month. In 2010, Zyprexa earned Eli Lilly almost $3.5 billion in U.S. sales. A generic version could be available in the U.S. in October 2011.

9. Concerta

Concerta is used to control symptoms of attention deficit hyperactivity disorder (ADHD) -- a condition marked by difficulty focusing and remaining still or quiet that affects adults and children. It's also used to treat narcolepsy. The drug, which belongs to a class of medications called central nervous system stimulants, works by changing the concentrations of certain chemicals in the brain. It costs up to $236 per month. In 2010, Concerta earned Johnson & Johnson $929 million in U.S. sales. A generic version could be available in the U.S. in 2011.

10. Protonix

Protonix is used to treat gastroesophageal reflux disease and conditions that cause the stomach to produce too much acid. The drug, which belongs to a class of medications called proton-pump inhibitors, works by decreasing the amount of acid made in the stomach. It costs up to $173 per month. In 2010, Protonix earned Pfizer $690 million in U.S. sales. A generic version could be available in the U.S. in 2011.

Copyright 2011 ABC News Radio


Lipitor Among Top Drugs Coming Off Patent by Year's End

Jupiterimages/Thinkstock(SANTA MONICA, Calif.) -- There could soon be some good news for consumers weary of soaring health care costs: The patents for several best-selling medications will expire this year, clearing the path for lower-cost generics to take their place.

According to IBIS World, an industry research firm, some of the blockbuster drugs whose patents expire this year are the cholesterol buster Lipitor, the antipsychotic Zyprexa, the antibiotic Levaquin, Concerta, a drug used to treat attention deficit disorder and attention deficit-hyperactivity disorder, and Protonix, an antacid.  Together, these drugs brought in more than $10 billion in sales in 2010.

Pfizer, the manufacturer of Lipitor, managed to hold off competition until later this year.  Ranbaxy, an India-based pharmaceutical company, agreed to delay the release of its generic version of Lipitor until Nov. 30.  According to its website, Ranbaxy will have the exclusive right to sell its drug in the U.S. for six months.

Experts say when generic versions of these drugs make it to market, pharmaceutical companies could face billions in potential losses, while consumers could save tens of billions of dollars a year.

"Studies suggest that the average cost of generics is 71 percent less than the cost of brand-name drugs," said James Zhang, associate professor and director of the Pharmaceutical Economics and Policy Research Program at Virginia Commonwealth University's School of Pharmacy in Richmond, Virgnia.  "Studies also suggest that generic drug use accounts for 63 percent of drug use."

Copyright 2011 ABC News Radio

ABC News Radio