Could active pharmaceutical ingredients be the key to generic drug patent issues?
Typically, drug manufacturers are protected by a twenty-year patent on their new drugs, which protects them from generic versions entering the market. Typically, the sale period of these new drugs is usually 8-12 years, depending on various factors, including testing, approval, development, and when the product was patented.
After the patent expires, it then opens the product to the generic market, where companies can reproduce the same drug with the same active ingredients and the same benefits and produce them at a much lower cost.
The Hatch-Waxman Act allows generic versions of the same product to use existing data if the active ingredients are the same, such as clinical trials and studies for their approval process, significantly reducing the time and costs associated with producing a drug.
What Are Advanced Patented Generics, and What Problem Do They Solve?
Utilizing SPID®-Technology, Laxxon can repurpose, reposition, and then relaunch generic active pharmaceutical ingredients (APIs) with patent protection while at the same time addressing common generic drug problems such as patent compliance, side effects, and dosage.
Their Advanced Patented Generics will be registered in the US under the FDA Section 505(b)(2), a fast-tracked regulatory approval process. In the EU, their Advanced Patented Generics will be registered as the Hybrid applications under Article 10(3) of Directive 2001/83/EC.
Some potential candidates for this process include:
Drugs that have changes in dosage form, formulation, strength, dosing regime, or route of administration.
Drugs that have new active ingredients.
Drugs that are a new combination product.
One example of Advanced Patented Generis is the drug Levodopa. Levodopa is currently considered by many to be the ‘gold standard’ when it comes to Parkinson’s treatment. However, many people acknowledge that there is still some room for improvement.
According to Mayo Clinic, “Parkinson’s disease is a progressive disorder that affects the nervous system and the parts of the body controlled by the nerves. Symptoms start slowly. The first symptom may be a barely noticeable tremor in just one hand. Tremors are common, but the disorder may also cause stiffness or slowing of movement.”
Sales for Levadopa are currently about $4.5 billion annually. However, according to Helmut Kerschbaumer, “Levodopa itself as a treatment still has opportunities for improvement. For example, one severe effect of Parkinson’s is the ‘freezing of gait’ effect, where patients are not able to move in the morning until they have their standard Levodopa dose. If patients are not able to move, they need a nurse or relative to administer the intake of Levodopa.
Laxxon has been developing a ‘new product generation’ of Levodopa with a delayed release program of 8-9 hours. This means the patient can, for example, take a second-generation version of the Levodopa tablet in the evening, and the medication will be released automatically after 8 to 9 hours to prevent the freezing of gait effect. This will be a dramatic improvement for Parkinson’s patients suffering from the freezing of gait.
Although Levodopa is already a generic drug, a new Levodopa generation classifies as an ‘Advanced Patented Generic Drugs’ because it is manufactured with our patented 3D screen printing technology. So, the drug is still generic, but due to the fact that it’s developed and manufactured with patented technology, automatically, the second-generation version is patented as well.”
New Product Generation Benefits Patients
Laxxon’s development of a second-generation version of Levodopa is just one example of Advanced Patented Generics and how they could ultimately benefit millions of people worldwide. Ultimately, developing a drug that provides a better experience to the end user should be the priority for any pharmaceutical company, and Laxxon is doing that using its Advanced Patented Generics program.
Eliminating negative side effects and adverse drug interactions and increasing the performance of medications such as Levodopa benefits the end user and improves the quality of life and treatment performance.
Laxxon Medical is dedicated to engineering patented 3D pharmaceutical solutions which optimize products and benefit patients. Our goal is to establish SPID®-Technology as a manufacturing process that has the individual and the pharmaceutical partner in mind.