Updated: Dec 5, 2022
Brand-name drug companies have a limited window to develop, test, trial, and market a product before it becomes available to generic companies.
When you go to the pharmacist to have a prescription filled and get asked whether you would like a generic option or brand name, have you ever wondered why some products don't have a generic version?
Ultimately, generic versions of medications perform the same role and are made using the same active ingredients but can cost much less than their brand-name counterparts. Why is that? How can one company make the same product and sell it for much less than someone else? Development, testing, and trials.
What one company does no longer has to be replicated like it once did in the past. To learn more about that, check out our article on the History of Generic Drugs In the United States. It focuses on the patent law, which makes this possible!
How Long Does a Drug Patent Last?
Drug patents are valid for 20 years from the date they were filed. It can take several years for the patent application process to be approved. However, the companies typically file the patent well before the drug hits the market to protect it from their competition, so the development, testing, and trials before the product hits the market consume 8-10 years of their 20-year patent.
Drug Patents and U.S Food & Drug Administration (FDA)
The process any drug must undertake to take a new drug to market is extensive. From start to finish, it could take anywhere from 8 to 10 years in some cases. In the past, drugs were released much sooner, and if any issues were found, they would be recalled. Now, the FDA requires rigorous testing and trialing and can come back to the manufacturer and demand more testing until they are 100% satisfied.
There are several different ways that large pharmaceutical companies attempt to extend this patent period to protect their exclusivity, including filing multiple patents on the same product. As a result, it’s estimated that sales of name-brand drugs drop by as much as 80% once the generic version hits the market.
Generic Drug Manufacturers and Patents
Most brand-name drug manufacturers that develop a new drug enjoy an 8 to 10 period of exclusive sales before they need to worry about a generic version being released. But obviously, they put a lot of time and money into developing a new drug, so they want to maximize the return on their investment.
Once the original patent expires, a generic version can be produced, but it must have an identical makeup to the original drug. However, it's not a free-for-all, and generic manufacturers still have guidelines they must follow, including:
The original patent must be expired.
The original manufacturer must certify that their patents weren’t infringed, invalid, or unenforceable.
There are no previous patents on the product or patents in countries where the drug has no protection under the law.
Brand-name drug companies don't just give up on their products after twenty years. Many companies will alter the original formula, go through the trial and testing process again, and create a new version under a new patent.
How Do Drug Patents Affect the Pharmaceutical Industry?
Most patents in the United States last 20 years from when the patent is filed. However, pharmaceutical patents are a little different because they allow manufacturers to apply for extensions to compensate for the delays in the FDA approval process. This will enable companies to apply for a five-year extension to cover delays in FDA approval of their drug.
This act gives brand-name drug manufacturers more time to profit off their drugs before a generic version is released. Another extension is available for drugs that are intended for children. This extension is known as the pediatric exclusivity extension and grants an additional six months to the patent but can only be used twice.
How Long Does A Drug Patent Last?
As you can see, drug patents protect the investment of the original manufacturer who made the drug but is limited, so more people may benefit from a cheaper generic version once the patent expires.
If you're using a brand-name drug with no generic alternative, then you can check out this website which lists drugs currently patented and when those patents are expected to expire.
3D Printing and the Future of Pharmaceutical Patents
Through its digitization of pharmaceutical manufacturing, our SPID®-Technology (Screen Printing Innovative Drug Delivery Technology) challenges traditional drug development processes and unlocks the potential for a new pharmaceutical landscape.
We offer pharmaceutical companies whose products are facing patent expiration an opportunity to "extend" their patents through Technology Transfer. Our additive manufacturing approach allows for the optimization and reformulation of such pharmaceutical products, which, in turn, are protected by the Laxxon IP. Further, SPID®-Technology can unlock the potential for personalized medicine.
Laxxon Medical is dedicated to engineering patented 3D pharmaceutical solutions which optimize products and benefit patients. We aim to establish SPID®-Technology as a manufacturing process with the individual and the pharmaceutical partner in mind.