Why Generic Drugs Are Made

You may wander why generic drugs are made. The patents for drugs usually last for twenty years however they are taken away early in the event of a process and with a long animal then human clinical trials it can take a decade or more from getting the patent to go into production.

Some companies may make a challenge for patents or get around them by making drugs that are going to do the same job but just a little bit different so that they are not affected by the existing patents.

Companies may also produce generic types of a patented drug in countries that are not covered by a patent.

Some companies can apply for a five-year extension to their patent to make up for the time that they are going through the approval period.

They cannot patent the active ingredient for more than the length of the paten or renew the paten that has already expired. They can however patent the inactive ingredients and different forms of compounds that are used.

Companies can protect their product by patenting the drug like the shape, size and taste of the brand name. These patents do not ever run out.

They may also do what is known as a research exemption to their patents. Other companies can do the research and make their own genetic versions of the drug while the patent protection is still available and can move fast to get their product onto the market once the patent expires.

The first company to file an accepted new drug application for a generic drug can also gain a 180-day exclusive to the produce and sell their generic version. This can be applied to the original innovator company as a way of prolonging their exclusive rights. However they are not using the original drug, as there has to be some differences to make it a generic brand.