Brand name drugs have long dominated the pockets of Americans throughout the country. Generics have been a source of respite for those struggling to pay the cost of their brand name counterparts. However, with such a large price gap, there are many concerns and misunderstandings regarding the differences between brand name and generic drugs.
The featured resource shared alongside this post is meant to shine a light on those concerns. Among the information shared you’ll come to understand that the patent process for newly developed drugs is both complex and expensive. Even worse off, is that a majority of these patents are largely unsuccessful. The companies that spend billions of dollars researching new drugs are often met with disappointment as these drugs rarely ever make their way onto pharmacy shelves. For the drugs that do end up being produced, companies responsible for producing them must place them under patent protection. This patent is what allows companies to share the exuberantly high prices they do on their drugs. These prices are a result of all the money invested into research and development by these companies in order to produce these drugs. Without this investment, the entire country would be much worse off from a health perspective.
Despite the advancements made in the way of drug production, the U.S government quickly learned that a majority of Americans would be unable to pay the costs associated with these brand name drugs for extended periods of time. As such, in 1984, the Hatch-Waxman Act was passed which provided the opportunity for generic drugs to compete with brand name drugs. The important consideration here was the generic drugs were not required to pass the pre-clinical and clinical trials that the name brand drugs had to pass prior to their large-scale availability. This allowed for generics to flood the market and provide Americans with more options at greatly reduced rates.
However, an important distinction must be made for those who opt into generic drugs more often than naught. There are two types of generics: authorized and non-authorized generic drugs. An authorized generic is a drug manufactured and marketed by the company responsible for the branded drug. Alternatively, these authorized generics can be manufactured by another company with the permission of the original manufacturer. A non-authorized generic is a drug made by a company other than the original manufacturer. Typically consumers can consider these authorized generics as possessing a higher sense of quality control and a more consistent availability which is helpful for expensive brand name drugs that are typically used long-term.
For consumers hoping to find some relief from the costs of brand name drugs where no generic is widely available, patience is imperative. In some instances, the generic alternative could be months, or years, away. Patents for these drugs are awarded for 20 years, and these companies can then obtain market protection extensions from the FDA as well. These drug companies are hoping to maintain exclusivity for as long as possible in most instances. However, United States law indicates that competitors are always allowed to challenge these patents. If successful in court, these companies are then able to produce generics and bring them to the market at a more accelerated rate.
For more information regarding branded and generic drugs and their patent processes, be sure to check out the featured resource coupled with this post. Courtesy of Rubin Anders