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Q: Why is there no generic form of Actos (Pioglitazone HCl)?
I see that a U.S. federal judge ruled on February 21, 2006 in favor of Takeda Pharmaceuticals North America, Inc. that a patent
covering the active ingredient of ACTOS is valid and enforceable through 2011. Yet this drug has been on the market since 1999 and has generated billions of dollars in profit but yet probably only cost them a billion dollars tops to get to market.
Why am I, under a typical insurance plan, paying $5 per pill (day) because it is a Brand name drug rather than $20 copay for generics. This is obsurd given that 30 million perscriptions have been written for this drug and that 20 million Americans have diabetes.
Does anyone know how they were able to renew this patent which is not typical? Does anyone know of a reliable foreign online pharmacy that sells Pioglitazone?
A: The patent wasn’t extended, it was enforced. It was a lawsuit against several companies who were applying for abbreviated new drug applications. ANDA’s are “application that contains information to show that the proposed product is identical in active ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics and intended use, among other things to a previously approved application (the reference listed drug (RLD). ANDAs do not contain clinical studies as required in NDAs but are required to contain information establishing bioequivalence to the RLD. In general, the bioequivalence determination allows the ANDA to rely on the agency’s finding of safety and efficacy for the RLD.” (fda.gov) The court ruled that the patent stands. A patent generally last 17-20 years. You can read more about patents here…http://www4.law.cornell.edu/uscode/html/uscode35/usc_sec_35_00000154—-000-.html
I think it’s ridiculous too. Unfortunately that’s the way it is…the drug companies get richer and we get poorer. Diabetes itself is one big business.
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