What Are Advanced Patented Generics?
Updated: Dec 5, 2022
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.