Friday, May 9, 2008

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Why Are There Ggeneric Drugs

Why Are There Ggeneric Drugs

Why are there generic drugs, surely all drugs are patented by those who develop them? Patents for drugs generally last for 20 years however they are taken out early in the development process and with lengthy animal then human clinical trials it can take a decade or more from getting the patent to going into production. Other companies may challenge patents or get around them by producing drugs which are do the same job but different enough not to be affected by existing patents. Companies may also produce generic versions of a patented drug in countries not covered by the patent. Companies can apply for a 5-year extension to their patent to make up for the time they were going through the approval process.

They cannot however patent the active ingredient for more than the length of the patent or renew patents that have expired, though they can patent the inactive ingredients and specific forms of compounds used.

Companies protect their product by patenting aspects of their drug such as the size shape and colour of the pill as well as the brand name, these patents do not run out.

There is also what is known as a research exemption to these patents, other companies can research and develop their own generic versions of the drug whilst the patent protection is still in place and so can move fast to get their product onto the market once the patent expires.

The first company to file an accepted abbreviated new drug application (for a generic) can also gain a 180 day exclusivity to produce a sell their generic version, this can be applied for by the original innovator company as a way of prolonging their exclusivity, though not using the original drug as there have to be some differences to make it a generic.

Monday, May 5, 2008

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Should I take generic drugs for Acid Reflux?

Should I take generic drugs for Acid Reflux?

Yes is the answer, generic drugs must show that they are bioequivalent to the original. They release just as much active ingredient in to the blood stream over exactly the same time period in other words they work exactly the same as the original in every way. The regulation and safety of generic drugs is just as rigorous as branded drugs and is just as tough. Generic drugs are manufactured in exactly the same way as the branded alternative and the facilities in which they are produced must adhere to exactly the same guidelines and regulations.

In fact 50% of generic drugs are produced by companies, which also produce branded products.

Generic drugs look different to branded versions because the look of the branded pill is often patented, so the generic version although containing exactly the same active ingredient differs in the non-active components to make the drug look different.

The vast majority of drugs prescribed are generics.Talk to your Doctor about the medication you are prescribed if you have any concerns. They should be able to give you accurate advice of the drug, its effects and side effects; the important thing is to be informed.

Generic drugs are cheaper than the original so reduce medical bills significantly. Sometimes especially if it is a new drug a generic version won’t be available.

Saturday, May 3, 2008

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Is there a difference between generic and branded drugs for Acid Reflux?

Is there a difference between generic and branded drugs for Acid Reflux?

Generic drugs do not differ greatly from their branded equivalents. All drugs are carefully regulated in exactly the same way to ensure they contain the correct amount of active ingredient as well as suitable inactive ingredients and are produced and manufactured in a similar way.

The generic drug must be shown to be bioequivalent to the branded alternative i.e. releases exactly the same amount of active ingredient over the same time scale.

The differences often lie mostly in the presentation of the drug for example a branded drug may produce pills which have a nice colouring and flavour, whereas the generic version will generally contain little more than the active ingredient. There should therefore be very little difference to the patient between branded and generic drugs and both have to go through the same regulators. Generics have a few advantages however over the branded alternatives.

The branded drug is often the first of it’s type to be developed and so the company spends a lot of money on developing, testing and patenting it’s new drug and consequently they are more expensive.

Generic Drugs appear once a patent has expired or in rare cases are different enough from the original to get around the patent whilst still doing the same job.

Generic drug with just smaller development and manufacture costs are often a lot cheaper and so are far more likely to be prescribed. This affordability also means increased availability especially to those in poorer countries.