Decision Resources, one of the world's
leading research and advisory firms for pharmaceutical and healthcare issues,
finds that widespread generic erosion of branded atypical antipsychotics will
cause the bipolar disorder drug market to decline from $6.3 billion in 2008 to
approximately $5 billion in 2018 in the United States, France, Germany, Italy,
Spain, the United Kingdom and Japan.
The new Pharmacor report entitled Bipolar Disorder finds that the market will
be constrained over the next several years by the patent expiries and
subsequent generic erosion of key antipsychotic agents such as AstraZeneca's
Seroquel, Eli Lilly's Zyprexa, Bristol-Myers Squibb/Otsuka's Abilify and
Pfizer's Geodon. In 2008, sales of atypical antipsychotics exceeded $4 billion
but generic competition, beginning in 2011, will cause sales of these agents
to decline to just under $3 billion by 2018, according to the report.
Additionally, patent expiries of branded antidepressants that include Wyeth's
(now Pfizer's) Effexor XR, Eli Lilly's Cymbalta/Xeristar and Forest/Lundbeck's
Lexapro/Cipralex will further constrain the market.
READ MORE @ REUTERS
Showing posts with label generics. Show all posts
Showing posts with label generics. Show all posts
Wednesday, November 11, 2009
Sunday, August 23, 2009
Cymbalta's waning patent and generic rivals soon could threaten Lilly's sales
Eli Lilly has enjoyed a wave of success with antidepressants, but analysts say such expertise must now bring new revenue growth.
Eli Lilly and Co. built a large part of its fortune selling medications for gloom, anxiety and withdrawal.
Now the question is: Can the Indianapolis drug maker keep riding the antidepressant wave? Can it find its next Prozac, its next Cymbalta?
Use of antidepressants in the U.S. doubled from 1996 to 2005, as more people sought out treatment and the stigma of depression has fallen, according to a study published in the August issue of the Archives of General Psychiatry. All told, about 10 percent of Americans, or 27 million people, were prescribed an antidepressant in 2005, up sharply from 13 million people a decade earlier.
"There's a huge increase in the recognition of depression and its symptoms," said Dr. Jim Martinez, an Indianapolis psychiatrist and adviser to Lilly. "And I think we've seen a growing improvement in public attitudes around seeking care for this disease."
But in recent years, the market has faced growing headwinds. Industry sales from antidepressants dipped nearly 14 percent in the past four years, even as the number of prescriptions dispensed for the pills has continued to climb. Medco Health Solutions, a huge pharmacy company that studies drug trends, is forecasting that use of antidepressants is likely to grow slowly over the next three years.
READ MORE @ INDIANAPOLIS STAR
Eli Lilly and Co. built a large part of its fortune selling medications for gloom, anxiety and withdrawal.
Now the question is: Can the Indianapolis drug maker keep riding the antidepressant wave? Can it find its next Prozac, its next Cymbalta?
Use of antidepressants in the U.S. doubled from 1996 to 2005, as more people sought out treatment and the stigma of depression has fallen, according to a study published in the August issue of the Archives of General Psychiatry. All told, about 10 percent of Americans, or 27 million people, were prescribed an antidepressant in 2005, up sharply from 13 million people a decade earlier.
"There's a huge increase in the recognition of depression and its symptoms," said Dr. Jim Martinez, an Indianapolis psychiatrist and adviser to Lilly. "And I think we've seen a growing improvement in public attitudes around seeking care for this disease."
But in recent years, the market has faced growing headwinds. Industry sales from antidepressants dipped nearly 14 percent in the past four years, even as the number of prescriptions dispensed for the pills has continued to climb. Medco Health Solutions, a huge pharmacy company that studies drug trends, is forecasting that use of antidepressants is likely to grow slowly over the next three years.
READ MORE @ INDIANAPOLIS STAR
Tuesday, January 27, 2009
Obama battles big pharma
Pfizer's latest mega deal reflects the threats faced by global drugs firms, not least from the new US president, says Alistair Dawber
"We will lower drug costs by allowing the importation of safe medicines from other developed countries, increasing the use of generic drugs in public programmes and taking on drug companies that block cheaper generic medicines from the market." The wording of President Obama's healthcare policy could not be clearer and should send a shiver through the boardroom of every major pharmaceutical group in the world.
For some time, the big players in the drugs market have faced a simple problem. Treatments that the likes of Pfizer, Novartis and GlaxoSmithKline (GSK) have spent years and millions of dollars developing are increasingly coming under threat from the generics companies, which invest nearly as much energy in challenging patents and developing cheaper alternatives. The established groups may consider the generics firms parasitical, but the likes of Barack Obama and the European Commission are tiring of the big beasts hiding behind patents ensuring that healthcare is more expensive to the ultimate user.
The European Commission said in November that the pharmaceutical groups are blocking the entry of new, cheaper drugs on to the market and that this cost EU healthcare providers, including the National Health Service, an estimated €3bn between 2000 and 2007. It added that it "will not hesitate to open antitrust cases against companies where there are indications that the antitrust rules may have been breached."
READ MORE @ INDEPENDENT
"We will lower drug costs by allowing the importation of safe medicines from other developed countries, increasing the use of generic drugs in public programmes and taking on drug companies that block cheaper generic medicines from the market." The wording of President Obama's healthcare policy could not be clearer and should send a shiver through the boardroom of every major pharmaceutical group in the world.
For some time, the big players in the drugs market have faced a simple problem. Treatments that the likes of Pfizer, Novartis and GlaxoSmithKline (GSK) have spent years and millions of dollars developing are increasingly coming under threat from the generics companies, which invest nearly as much energy in challenging patents and developing cheaper alternatives. The established groups may consider the generics firms parasitical, but the likes of Barack Obama and the European Commission are tiring of the big beasts hiding behind patents ensuring that healthcare is more expensive to the ultimate user.
The European Commission said in November that the pharmaceutical groups are blocking the entry of new, cheaper drugs on to the market and that this cost EU healthcare providers, including the National Health Service, an estimated €3bn between 2000 and 2007. It added that it "will not hesitate to open antitrust cases against companies where there are indications that the antitrust rules may have been breached."
READ MORE @ INDEPENDENT
Thursday, September 18, 2008
Obama & McCain Agree On One Thing: Generics
You’re not surprised, are you? In any event, expanding the use of low-cost generics, including versions of biologics, would be near the top of their health care agendas, according to their advisers, who were speaking at a conference for the generic industry.
“We know that expanding the use of generics and eliminating barriers to that goal must be a centerpoint of any health reform effort,” Dora Hughes, a health care adviser for Obama, according to the Associated Press. And McCain adviser Douglas Holtz-Eakin echoed the sentiment: “Controlling health care costs has to be the imperative of any effective health care reform.”
READ MORE @ PHARMALOT
“We know that expanding the use of generics and eliminating barriers to that goal must be a centerpoint of any health reform effort,” Dora Hughes, a health care adviser for Obama, according to the Associated Press. And McCain adviser Douglas Holtz-Eakin echoed the sentiment: “Controlling health care costs has to be the imperative of any effective health care reform.”
READ MORE @ PHARMALOT
Thursday, July 3, 2008
FDA Approves First Generic Risperidone to Treat Psychiatric Conditions
The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions.
"This generic drug approval is another example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary Buehler, director of the FDA's Office of Generic Drugs in the Center for Drug Evaluation and Research.
Varying strengths of risperidone tablets, manufactured by TEVA Pharmaceuticals USA, have been approved. Specific information about the strengths approved can be found at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
The labeling of the generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity.
The generic risperidone products will have the same safety warnings as Risperdal, including a Boxed Warning that cautions that older patients with dementia-related psychosis treated with atypical anti-psychotic drugs are at increased risk of death compared with those taking placebo. Risperdal, and other antipsychotic medications, are not FDA-approved to treat dementia-related psychosis. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called "off-label" use and falls within the practice of medicine.
from FDA NEWS
"This generic drug approval is another example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary Buehler, director of the FDA's Office of Generic Drugs in the Center for Drug Evaluation and Research.
Varying strengths of risperidone tablets, manufactured by TEVA Pharmaceuticals USA, have been approved. Specific information about the strengths approved can be found at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
The labeling of the generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity.
The generic risperidone products will have the same safety warnings as Risperdal, including a Boxed Warning that cautions that older patients with dementia-related psychosis treated with atypical anti-psychotic drugs are at increased risk of death compared with those taking placebo. Risperdal, and other antipsychotic medications, are not FDA-approved to treat dementia-related psychosis. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called "off-label" use and falls within the practice of medicine.
from FDA NEWS
Saturday, February 16, 2008
Generics Capture 65% of U.S. Market as Costs Rise (Update1)
Two-thirds of prescriptions filled in the U.S., the most ever, are cheap copies of brand names made by generic-drug companies.
Generics accounted for 65 percent of the U.S. market last year, up from 63 percent in 2006, according to data released today at the Generic Pharmaceutical Association's annual industry meeting in Boca Raton, Florida. Costlier brand-name drugs made up about 80 percent of dollars spent on prescriptions in each year.
The figures, compiled by the research firm IMS Health Inc., show generic drugmakers are capitalizing on expiring patents and efforts by insurers to rein in health-care costs. The companies seek further gains this year as drugs with $20 billion in annual sales lose patent protection and the presidential candidates promise to make generic drugs more widely available.
``We're poised to do very well,'' said Kathleen Jaeger, president of the Arlington, Virginia-based Generic Pharmaceutical Association, in an interview yesterday. ``All the candidates believe that generics are part of the answer.''
READ MORE @ BLOOMBERG
Generics accounted for 65 percent of the U.S. market last year, up from 63 percent in 2006, according to data released today at the Generic Pharmaceutical Association's annual industry meeting in Boca Raton, Florida. Costlier brand-name drugs made up about 80 percent of dollars spent on prescriptions in each year.
The figures, compiled by the research firm IMS Health Inc., show generic drugmakers are capitalizing on expiring patents and efforts by insurers to rein in health-care costs. The companies seek further gains this year as drugs with $20 billion in annual sales lose patent protection and the presidential candidates promise to make generic drugs more widely available.
``We're poised to do very well,'' said Kathleen Jaeger, president of the Arlington, Virginia-based Generic Pharmaceutical Association, in an interview yesterday. ``All the candidates believe that generics are part of the answer.''
READ MORE @ BLOOMBERG
Sunday, December 23, 2007
Generic Antidepressant May Affect Wyeth
The difference between a pill and a capsule might not seem big, but it could result in hundreds of millions of dollars in lost sales for Wyeth's top drug.
The Madison, N.J.-based company makes the best-selling antidepressant in the world, Effexor, with sales on pace to exceed $3.7 billion this year. The most common version is an extended-release capsule, Effexor XR.
Until recently, it seemed Wyeth would be the exclusive seller of extended-release Effexor in the United States through July 2010, thanks to its resolution of patent litigation in 2005.
But now Wyeth's market exclusivity is being threatened. Sun Pharmaceutical Industries Ltd., a generics manufacturer in India, has applied for U.S. Food and Drug Administration approval to sell a drug with the same active ingredient as Effexor XR, but with an important difference: It's an extended-release tablet, not a capsule.
FDA approval of what is likely to be a lower-priced drug from Sun might come when patent protection for Effexor's active ingredient, venlafaxine, runs out in June 2008. Patent protection for the capsule formulation expires later. Sun's different formulation should allow it to sidestep Wyeth's patent rights, and Wyeth already has told Sun it won't sue for patent infringement.
READ MORE @ AP
The Madison, N.J.-based company makes the best-selling antidepressant in the world, Effexor, with sales on pace to exceed $3.7 billion this year. The most common version is an extended-release capsule, Effexor XR.
Until recently, it seemed Wyeth would be the exclusive seller of extended-release Effexor in the United States through July 2010, thanks to its resolution of patent litigation in 2005.
But now Wyeth's market exclusivity is being threatened. Sun Pharmaceutical Industries Ltd., a generics manufacturer in India, has applied for U.S. Food and Drug Administration approval to sell a drug with the same active ingredient as Effexor XR, but with an important difference: It's an extended-release tablet, not a capsule.
FDA approval of what is likely to be a lower-priced drug from Sun might come when patent protection for Effexor's active ingredient, venlafaxine, runs out in June 2008. Patent protection for the capsule formulation expires later. Sun's different formulation should allow it to sidestep Wyeth's patent rights, and Wyeth already has told Sun it won't sue for patent infringement.
READ MORE @ AP
Saturday, October 13, 2007
Report questions generic antidepressant - ConsumerLab.com finds cheaper drug may not work the same as brand
For seven years Linda Douglas has been treating her depression with the antidepressant Wellbutrin, first with a twice-a-day version and then later with a more convenient once-a-day pill called Wellbutrin XL. The drug, she says, "renewed my joy for living."
All that changed earlier this year when she switched to a generic version of Wellbutrin XL 300 milligrams to save money. Instead of paying $250 for a three-month supply of the brand drug, she was paying just $53. The cost savings were welcome, but Douglas, 48, a telecommunications project manager in Columbia, Md., says the depression returned during the six months she took the generic antidepressant.
READ MORE @ MSNBC
All that changed earlier this year when she switched to a generic version of Wellbutrin XL 300 milligrams to save money. Instead of paying $250 for a three-month supply of the brand drug, she was paying just $53. The cost savings were welcome, but Douglas, 48, a telecommunications project manager in Columbia, Md., says the depression returned during the six months she took the generic antidepressant.
READ MORE @ MSNBC
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