Mutual and the Obama administration want that protection extended to the design of the drug, since the generic is an exact copy of the brand-name drug that has already been approved by the federal government.
So filling in that -- what's commonly known as -- ironically, in health care -- the doughnut hole, about -- that up to 50 percent of the name brand -- the price for that name brand drug would be paid for, and I think that provides a hefty discount that will bear appreciable benefits for seniors all over the country.
Experts estimate that the average rebate for a brand-name drug in 2011 reaches 40%.
FORBES: Senior Citizens Will Pay Dearly For Health Care Price Controls
More risky are cases where generic drugs are not functionally equivalent to the brand-name drug.
Taking advantage of advances in technology, some of the new products may even be better than the original, brand-name drug.
If there's no exact generic equivalent to the brand-name drug that you are taking, there may be similar drugs in the same class that are close enough.
But a Consumer Reports analysis found that the FDA was as likely to warn about manufacturing issues at a brand-name drug factory as a generic one, Dr. Santa says.
Such lawsuits are strengthened if the brand-name drug company files a new patent covering, say, the colour of the pill bottle just before the main patent is about to expire.
According to the 2010 RBC Capital Markets study, when trial victories, settlements between drugmakers and dropped cases are combined, generic companies were able to bring their product to market before the brand-name drug's patent expired in 76 percent of the 371 drug patent suits decided from 2000 through 2009.
The only losers were patients who have had to keep paying much higher prices for their name-brand-only drug.
That's good news for Andrx, which hopes to sell its delayed-release lovastatin as a new drug under the brand name Altocor.
Left unanswered in the FDA's latest guidelines is whether the bio-knockoffs can use the same name as the original brand drug.
In separate experiments, the two flavonoids were added to lung-cell cultures before, during and after infection with H5N1, and tested on H5N1-infected cells treated with zanamivir (brand name Relenza), an antiviral drug prescribed to flu patients.
The drug, sold under the brand name Aredia, was originally used to treat bone complications caused by breast cancer and multiple myeloma.
Lovaza was launched in the U.S. in 2004 under the brand name Omacor by Reliant Pharmaceuticals, a specialty drug company linked to the billionaire Pritzker clan.
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Beyond that, drug company- discounts on brand-name drugs and federal subsidies and discounts for all drugs will gradually reduce the gap, eliminating it by 2020.
The drug will be sold under the brand name Vascepa.
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The drug is Taxol, Bristol's brand name for paclitaxel, a trace compound found in the bark of the Pacific yew tree in the northwestern U.S. During the 1970s researchers for the U.S. government's National Cancer Institute discovered that paclitaxel stops the growth of some cancerous tumors.
Such pay-for-delay deals arise when generic companies file a challenge at the Food and Drug Administration to the patents that give brand-name drugs a 20-year monopoly.
The US FDA today approved a new weight loss drug that will be called Qsymia, the brand name for the combination of two previously approved drugs, phentermine and extended-release topiramate.
The same drug is expected to be approved under a different brand name to treat urinary incontinence later this year.
The Obama administration wants Big Pharma to stop paying generic drug competitors to delay releasing cheaper versions of brand-name drugs.
The stock dropped after Cephalon announced that a new study had shown that its main drug, a compound called modafinil sold under the brand name Provigil, was not effective in treating Attention Deficit Hyperactivity Disorder (ADHD).
Mutual, however, argues that federal law preempts this type of claim, because the FDA had already approved its drug and federal law also requires a generic drug to have the same design as the brand-name medication ( here is the petition).
FORBES: Good For Generic Drugmakers? White House To Argue In Favor Of Preemption
For 60 years, doctors have had only one pill to prevent clotting: warfarin, a drug originally derived from rat poison and sold under the brand name Coumadin by Bristol-Myers Squibb (nyse: BMY - news - people ).
Big Pharma has managed to completely undermine Hatch-Waxman's intent, which was to put in place mechanisms that encouraged generic drug makers to challenge the weak patents often used to protect brand-name drugs.
But the amount of money being poured by the U.S. into brand-name drugs is striking, and can be expected to drive the political debate about drug costs in America.
With billions of dollars at stake and neither company certain how it might fare in court, a brand-name manufacturer might prefer to pay its potential competitor substantial compensation to delay its generic drug and the generic maker might welcome a hefty payoff rather than face the uncertainties of litigation and marketing.
FORBES: The Times Reproduces The FTC's Flawed Position On Drug Patent Settlements
Because generic companies tend to challenge patents of every successful drug, the FTC's position would impose onerous legal costs on brand-name drugmakers and limit their ability to fund expensive research to create new drugs, said the Pharmaceutical Research and Manufacturers of America, which represents brand-name drugmakers.
You can search it to see whether your doctor is receiving drug company money to give speeches and talks to other doctors that help promote brand-name drugs.
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