When a pharmaceutical company creates a new medication, they place the finished product under patent protection. This is because the research and development stages involved in delivering healthcare solutions are so expensive that sponsors are rewarded the sole right to sell the drug for a limited time.
The innovator company has the right to give the drug a name that is both easy to market and will ensure maximum brand awareness until the patent expires. Once that period ends, other manufacturers are allowed to sell what is known as a generic version of the same drug, which will be named after the active ingredient.
These generic medications are not inferior to the original product. According to the FDA, generic drugs are created to be the same as an already existing brand-name drug when it comes to dosage, form, safety, strength, route of administration, quality and performance characteristics. That is to say that it works exactly the same as its branded equivalent.
Here, we cover how these alternatives could be the key to managing your symptoms and keeping your healthcare costs down.
Do generic drugs work the same as branded medicine?
Yes. In fact, drug companies are required by the FDA to demonstrate that their generic medicine can be effectively substituted and subsequently provide the same clinical benefit as the brand-name alternative. When these drug companies submit their abbreviated new drug application (ANDA), they must show:
- The active ingredient in the generic drug is the same in the original
- The inactive ingredients of the generic drug are acceptable
- The manufacturing standards of the generic drug are of the same level as the original
- The container of the generic drug is appropriate
- The drug information label is the same as the label on the branded equivalent
As a result, the person taking the drug experiences exactly the same level of benefit as the typically higher-priced, branded medication – they just have a slower time-to-market on account of the patent put in place by the original manufacturer.
It is worth bearing in mind that the patent can often even delay the approval process of these generic drugs. While this can be challenged by other drug manufacturers, in most cases, the FDA must comply with the delays that the patents and exclusivities impose.
Why do generic drugs look different?
Due to trademark laws in the United States, pharmaceutical companies are not allowed to create a generic drug that looks exactly like the counterpart that is already on the market. For this reason, generic manufacturers typically change the colors and flavorings of their medication so that they stand apart from the branded original but in no way affect the performance of the drug.
That being said, the FDA found that changing the size, shape and color of the pills caused confusion among people, especially the elderly. Research showed that physical characteristics impacted patient compliance and medication errors, as some generic drugs could not easily be identified as an alternative solution. For this reason, the FDA produced guidance on how manufacturers of generic drugs can differentiate their product while still making them visually recognizable.
This guidance can be found in their application process, and includes a box where companies are also allowed to justify any areas of their medication that may exceed the parameters of the original. To ensure that these pharmaceutical companies maintain the standards of the prototype, the FDA also conducts 3,500 inspections of manufacturing plants a year, ensuring all suppliers are operating according to the agency’s regulations.
Why are some generic drugs cheaper than others?
As the pharmaceutical leaders producing the branded drugs are required to conduct all the market research, along with animal and clinical (human) studies, they typically sell the drug at a higher price in order to recuperate the production costs. Generic manufacturers are obviously saved this expense and are therefore able to sell their products at a substantially lower price.
The other big reason is that multiple companies will produce a generic alternative to a branded drug. As with any commodity, the more competition that exists, the lower the prices. This is something that the FDA actively encourages, as it gives people a more varied selection to choose from when it comes to managing their own medication.
In fact, evidence shows that prices are 54% lower than the branded drug price if there are two competitors. What is more, prices are 95% lower with six or more competitors. That is why it is important that US citizens continue to vary their medication and make the most of a market that is not dominated by single companies.
How can I find non-branded versions of my medication?
Medix purposely stocks various generic and non-generic medicine so that you have a wide selection to choose from. We understand the importance of managing your own medication and appreciate that the rising cost of prescriptions is crippling some American families. Our aim is to provide an affordable, convenient solution that addresses your healthcare needs.
In need of medication and would like to hear how we can help? Get in touch on 1-866-500-6633 (toll-free phone number) or +44 1438 500111 (international phone number). Alternatively, feel free to request a callback.