In the U.S., the first generic drug maker to challenge the patents on a branded drug can be granted a six-month monopoly that prevents other copycats from entering the market.
Normally, the first generic drug company to receive approval from the U.S. Food and Drug Administration receives the right to be the exclusive manufacturer of a generic for six months.
Bernstein analysts Tim Anderson and Ronny Gal are out this morning with a note to investors suggesting that generic Lipitor could be delayed because of manufacturing problems at Ranbaxy, the first generic drug maker to file with the Food and Drug Administration and the company with whom Pfizer settled.
During the first 180 days a generic drug is on the market, the generic company has a virtual market monopoly for its formulation.
The pill, a fixed combination of two generic ingredients, is the first drug tested only in African-Americans.
Under existing regulations, generic firms can compete against an off-patent branded drug and battle for first-to-file, 180-day exclusivity to market a generic replacement.
U.S. law in many cases gives the first generic company to get approval for a particular copycat drug six months of exclusivity, creating a duopoly between the original brand and the new generic.
's first-quarter net income rose 53 percent despite growing generic drug competition as the world's second-largest drugmaker benefited from a gain related to a joint venture with China.
Revlimid is the chemical cousin and heir to Celgene's first drug, Thalomid, which is still probably better known by its generic name, thalidomide.
The first generic versions will go for sale, marking the end of a brand that has dominated the drug industry, lowered the cholesterol of tens of millions of patients, and generated more in annual sales than Major League Baseball or the entire box office of U.S. movies.
In December 2006, the first generic versions of the popular anti-depressant Wellbutrin XL were approved by the FDA. The drug comes in two dosage strengths, 150 milligrams and 300mg.
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