Why is there no generic form of Actos (Pioglitazone HCl)?

Question

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?

Answer 1

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.

Answer 2

You won't be able to find an online pharmacy who sells pioglitazone. If you do, it's not pioglitazone. The previous submitter is exactly right. Pharmaceutical companies pull some pretty good tricks. The FDA also grants special exceptions for companies under certain conditions. Especially when the drug is a first generation. Its possible ACTOS falls under these conditions. More than likely, the drug synthesis didn't take long. It was likely synthesized around 1991 and marketed in 1999. That would give 20 yrs of patent until 2011.
As far as the insurance thing goes...that's completely up to the insurance company. The insurance companies use brand and generics as a tactic to determine price. They COULD charge you $1 as a copay for anything but it wouldn't be cost effective for them.
--pharmacist

Answer 3

That's exactly extremely common. There are many tricks a pharmaceutical company can pull to extend a patent. Normal patent length for drugs is about 20 years. The patent begins at the point of drug synthesis. Normally, about 10 years of the patent is exactly spent in development. The industry tries to regain some of those years.
I would not trust foreign online pharmacies. I've heard too many bad stories.

Answer 4

you may desire to be very careful and terrific while writing chemical formulation. i think of which you recommend HCl. notice that it rather is Capital H that's hydrogen, and CapitalC observed via decrease case l that's chlorine - not a capital L as you have writtem there is no substance in chemistry HCL. Now: wisely, HCl is hydrogen chloride. this might nicely be a gas at established room temperature and tension. that is accessible from chemical providers particularly boxes for chemical synthesis. If the HCl gas is dissolved in water, that's then stated as hydrochloric acid, even though it nevertheless has the formulation HCl. related to the main focused style of HCl answer available is 36% via mass in water, and this answer has a density of one million.18g/cm³